Social IsolationCOPING CREWNCT05019053
Acceptability/Feasibility of COVID-19 Intervention
A study testing Coping Crew in people with Social Isolation and Emotional Disorder, run by Ohio University at 1 site in United States.
Trial summary
The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Isolation, Emotional Disorder
- What is being tested?
- Coping Crew
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated anxiety sensitivity (i.e., a score greater than 1 standard deviation above the mean on the Anxiety Sensitivity Index-3; Taylor et al., 2007)
- Elevated Intolerance of uncertainty (i.e., a score greater than 1 standard deviation above the mean on the Intolerance of Uncertainty Scale - Short Form; Carleton et al., 2007)
- Elevated loneliness (i.e., a score greater than 1 standard deviation above the mean on the NIH Toolbox Loneliness Scale; Cyranowski et al., 2013)
- Access to a device with internet connection
Who cannot join
- Participants who have previously received other FEAR Lab interventions or participated in a focus group related to that intervention (20-X-184; 20-X-204) will be excluded due to the overlap of intervention material.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ohio University
Athens, Ohio, 45701
Nicholas P Allan, Ph.D
About this study
Official title: Acceptability/Feasibility of COVID-19 Intervention of a Virtual Group Intervention for COVID-19 Distress
The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll, 45% of respondents reported that the coronavirus has had a negative impact on their mental health. This is reflected in Southeastern Ohio. In data that the investigators collected from 317 Ohio University faculty, staff, and students from late May to early June, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severe levels of depression and 57% reported the COVID-19 outbreak was impacting their sense of social connection much or very much. Despite the significant community need for accessible and affordable care, there are currently no evidence-based interventions for individuals coping poorly with coronavirus-related distress. The investigators have developed a virtual group-based intervention targeting cognitive biases that amplify the experience of stress and anxiety (i.e., amplifying cognitions; Coping with Coronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing this intervention in a scientifically rigorous manner is to refine the manual and procedures and conduct a pilot test of the intervention.
Read the detailed description
There is a coming mental health crisis in response to the COVID-19 pandemic. Already, rates of depression, anxiety, and suicide are elevated in response to the pandemic. A recent study of more than 5,400 people in the US found prevalence rates of anxiety and depression in June of 2020 were 3-4 times higher than these rates in June of 2019. In this same study, 41% of respondents in June 2020 reported experiencing an adverse mental or behavioral health condition, including 13% who endorsed using substances to cope with stress or emotions and 11% who reported seriously contemplating suicide in the prior 30 days. Thus, heightened anxiety, stress, and depression will likely continue to lead to increases in self-harm and maladaptive substance use if left unchecked.
It is crucial that empirically validated psychotherapies be developed to meet these needs. These treatments must address how common barriers to treatment, including time, cost, transportation, and stigma about mental health may be exacerbated by the pandemic. The investigators developed a brief, virtual group-based intervention, framed as educational, Coping with Coronavirus-Related Emotions and Worries (COPING CREW), to address these barriers. This intervention was developed over the summer by Drs. Allan, Suhr, and Austin, working with two graduate student research assistants for administration by clinical psychology graduate student therapists as part of their practicum experience at the Ohio University Psychology and Social Work Clinic (PSWC). A benefit of this approach, therefore, is that this intervention is highly scalable.
Theoretical models posit the short- and long-term stressors experienced during the pandemic exacerbate the experience of negative emotions an individual is already predisposed to experience. That is, people who are already experiencing mental health issues are going to experience more severe issues and people who may not already be experiencing mental health issues are more likely to develop mental health issues during the pandemic. Cognitive risk factors (i.e., amplifying cognitions) such as anxiety sensitivity (fear of anxiety sensations), intolerance of uncertainty (fear of the unknown), and loneliness (the subjective feeling of isolation) increase the experience of negative emotions as well as the likelihood of unhealthy coping behavior such as increased alcohol consumption or self-harm.
Anxiety sensitivity, intolerance of uncertainty, and loneliness can be reduced through brief interventions applying cognitive-behavioral therapy principles. Reductions in these constructs lead to later reductions in anxiety, depression, and suicide. Targeting these risk factors appears critical to address distress due to COVID-19. In 317 Ohio University faculty, staff, and students, anxiety sensitivity, intolerance of uncertainty, and loneliness accounted for 63%-75% of the variance in ratings of anxiety, depression, and suicidality as well as 49% of COVID-related disability. These findings highlight the prominent role these risk factors play in the distress many individuals are experiencing due to COVID-19. The investigators have developed a virtual group-based intervention targeting risk factors that amplify the experience of emotional distress; the next steps in developing a scientifically rigorous intervention that can be disseminated broadly is to develop and pilot test this intervention.
The goals specific to this project are to 1) engage stakeholders in the design of a brief group-based treatment to improve COPING CREW and 2) to conduct a Stage I pilot trial through evaluating the acceptability and feasibility of COPING CREW.
Aim 1: Refine a prototype for COPING CREW by working virtually with a community partner stakeholder advisory group (SAG) as well as participants receiving the intervention. The investigators will develop a SAG comprising one participant from each community partner. The investigators will meet with the SAG at least three times during the 1-year project. Meetings will occur prior to starting COPING CREW groups, after running the first two groups, and after all four groups have been completed. The investigators anticipate that building a strong relationship with this SAG will increase treatment relevance to clientele, treatment engagement, and treatment dissemination. In turn, this will enhance the durable impacts and sustainability of COPING CREW. In addition to SAGs, the investigators will also utilize a systematic approach to engage with participant stakeholders by asking for feedback about the intervention (the Exit Interview). The investigators have used these intervention modules separately a number of times but have yet to examine these modules as part of the same intervention. Thus, participants will provide important information on how to tailor the intervention, including the order of the components, the amount of homework specific to each component, and the length of time before the booster session to best meet their needs. Although the investigators are confident that COPING CREW will largely be viewed as acceptable, it can be modified to increase acceptability by effective engagement with community partners. Solicitation of feedback will occur via two mechanisms. First, information related to adaptation will be obtained from quantitative and qualitative feedback during the intervention. Second, information related to adaptation and engagement will also be collected in separate, focused feedback sessions with COPING CREW participants.
Aim 2: Examine acceptability and feasibility of COPING CREW, delivered virtually. A pilot one arm trial will be conducted, delivering the intervention to 24 participants across 4 groups.
H1: It is hypothesized that the intervention will demonstrate high acceptability and feasibility (as measured by completion rates and favorable ratings of satisfaction) across intervention modules and components within sessions. Components will include psychoeducation, challenging cognitive biases or mythbusting, behavioral exposure, behavioral experiments, and ecological momentary intervention (EMI) for treatment monitoring and homework tracking.
- Conditions
- Social Isolation, Emotional Disorder
- Being tested
- Coping Crew
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping CrewBehavioural
Coping Crew consists of five 60-minute virtual intervention sessions coinciding with five weeks of EMI. Participants will receive psychoeducation, challenge cognitive biases or mythbust, and participate in behavioral exposure and behavioral experiments. An EMI component of this treatment will be included for the purpose of treatment monitoring and homework tracking. Participation in this EMI component involves the daily report of levels of anxiety, depression, stress, and loneliness. When participants endorse elevated levels on any of these constructs, they will receive a targeted message reminding them of the topics covered in COPING CREW. One month after the intervention session, COPING CREW participants will complete follow-up questionnaires and interview. Participants will also participate in a feedback session 3 months after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Coping Crew Intervention | Experimental | Interested participants who meet the screening criteria will be assigned to receive COPING CREW. First, following informed consent, eligible participants will complete a baseline assessment appointment in the week prior to the group beginning. During the baseline appointment, participants will provide informed consent, be instructed in the use of Microsoft Teams, complete a battery of self-report measures, be given a semi-structured diagnostic interview, and follow instructions to install a mobile app that will be used to track their mood and homework. Then, 4 groups of COPING CREW, with 6 participants per group, will be run. Participants will complete four weekly 60-minute virtual intervention sessions followed by a booster session two weeks later. Participants will complete daily surveys and homework assignments on their mobile devices. Links to follow-up surveys will be sent to participants at 1- and 3-month follow-ups. Receives: Behavioral: Coping Crew |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8
The Client Satisfaction Questionnaire-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The Client Satisfaction Questionnaire-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale. Possible total scores range from 8 to 32. Greater satisfaction is indicated by higher scores.
Measured: Immediately after the intervention
Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention
Feasibility will also be determined based on response rates for Ecological Momentary Assessment/Ecological Momentary Intervention. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery.
Measured: 5-week EMA/EMI, During the Intervention (Weeks 1-5)
Secondary outcomes (65)
COVID-19 Impact Battery - Behavior
This 12-item scale was created to measure behavioral patterns in response to the COVID-19 outbreak. Participants responded to this scale by rating the extent to which they "have engaged in the following behaviors in response to COVID-19" using a five-point scale (from 0 = "Not at all" to 4 = "Very much"). Each of the potential behaviors listed in this scale (e.g., "Using hand sanitizer") were rated by participants. Possible total scores range from 0 to 48. A higher rate of engagement in the listed behaviors is indicated by a higher score.
Measured: Baseline, pre-intervention
COVID-19 Impact Battery - Behavior
This 12-item scale was created to measure behavioral patterns in response to the COVID-19 outbreak. Participants responded to this scale by rating the extent to which they "have engaged in the following behaviors in response to COVID-19" using a five-point scale (from 0 = "Not at all" to 4 = "Very much"). Each of the potential behaviors listed in this scale (e.g., "Using hand sanitizer") were rated by participants. Possible total scores range from 0 to 48. A higher rate of engagement in the listed behaviors is indicated by a higher score.
Measured: Immediately after the intervention
COVID-19 Impact Battery - Behavior
This 12-item scale was created to measure behavioral patterns in response to the COVID-19 outbreak. Participants responded to this scale by rating the extent to which they "have engaged in the following behaviors in response to COVID-19" using a five-point scale (from 0 = "Not at all" to 4 = "Very much"). Each of the potential behaviors listed in this scale (e.g., "Using hand sanitizer") were rated by participants. Possible total scores range from 0 to 48. A higher rate of engagement in the listed behaviors is indicated by a higher score.
Measured: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Behavior
This 12-item scale was created to measure behavioral patterns in response to the COVID-19 outbreak. Participants responded to this scale by rating the extent to which they "have engaged in the following behaviors in response to COVID-19" using a five-point scale (from 0 = "Not at all" to 4 = "Very much"). Each of the potential behaviors listed in this scale (e.g., "Using hand sanitizer") were rated by participants. Possible total scores range from 0 to 48. A higher rate of engagement in the listed behaviors is indicated by a higher score.
Measured: Follow-Up, 3 months after the intervention
COVID-19 Impact Battery - Worry
This 11-item scale was created to measure worry and distress in response to the outbreak of COVID-19. The items on this measure use a five-point scale (from 0 = "Not at all" to 4 = "Very Much"). Participants used this scale to rate each item (e.g., "I worry that I will lose my employment") based on the degree to which it has caused distress. Possible total scores range from 0 to 44. Greater worry and distress is indicated by higher scores.
Measured: Baseline, pre-intervention
COVID-19 Impact Battery - Worry
This 11-item scale was created to measure worry and distress in response to the outbreak of COVID-19. The items on this measure use a five-point scale (from 0 = "Not at all" to 4 = "Very Much"). Participants used this scale to rate each item (e.g., "I worry that I will lose my employment") based on the degree to which it has caused distress. Possible total scores range from 0 to 44. Greater worry and distress is indicated by higher scores.
Measured: Immediately after the intervention
COVID-19 Impact Battery - Worry
This 11-item scale was created to measure worry and distress in response to the outbreak of COVID-19. The items on this measure use a five-point scale (from 0 = "Not at all" to 4 = "Very Much"). Participants used this scale to rate each item (e.g., "I worry that I will lose my employment") based on the degree to which it has caused distress. Possible total scores range from 0 to 44. Greater worry and distress is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Worry
This 11-item scale was created to measure worry and distress in response to the outbreak of COVID-19. The items on this measure use a five-point scale (from 0 = "Not at all" to 4 = "Very Much"). Participants used this scale to rate each item (e.g., "I worry that I will lose my employment") based on the degree to which it has caused distress. Possible total scores range from 0 to 44. Greater worry and distress is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
COVID-19 Impact Battery - Disability
This 7-item scale was created to measure the presence of difficulties in response to the outbreak of COVID-19. Participants were asked to rate difficulties on a five-point scale from 0 ("None") to 4 ("Extreme or cannot do"). Participants used this scale to rate the degree of difficulties experienced in the preceding 30 days because of the COVID-19 outbreak. Possible total scores range from 0 to 28. A greater rate of disability is indicated by a higher score.
Measured: Baseline, pre-intervention
COVID-19 Impact Battery - Disability
This 7-item scale was created to measure the presence of difficulties in response to the outbreak of COVID-19. Participants were asked to rate difficulties on a five-point scale from 0 ("None") to 4 ("Extreme or cannot do"). Participants used this scale to rate the degree of difficulties experienced in the preceding 30 days because of the COVID-19 outbreak. Possible total scores range from 0 to 28. A greater rate of disability is indicated by a higher score.
Measured: Immediately after the intervention
COVID-19 Impact Battery - Disability
This 7-item scale was created to measure the presence of difficulties in response to the outbreak of COVID-19. Participants were asked to rate difficulties on a five-point scale from 0 ("None") to 4 ("Extreme or cannot do"). Participants used this scale to rate the degree of difficulties experienced in the preceding 30 days because of the COVID-19 outbreak. Possible total scores range from 0 to 28. A greater rate of disability is indicated by a higher score.
Measured: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Disability
This 7-item scale was created to measure the presence of difficulties in response to the outbreak of COVID-19. Participants were asked to rate difficulties on a five-point scale from 0 ("None") to 4 ("Extreme or cannot do"). Participants used this scale to rate the degree of difficulties experienced in the preceding 30 days because of the COVID-19 outbreak. Possible total scores range from 0 to 28. A greater rate of disability is indicated by a higher score.
Measured: Follow-Up, 3 months after the intervention
COVID-19 Items
Investigator-created questions assessing demographic information related to the COVID-19 pandemic will be administered.
Measured: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
The PROMIS Anxiety scale is an 8-item scale that measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater anxiety is indicated by higher scores.
Measured: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
The PROMIS Anxiety scale is an 8-item scale that measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater anxiety is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
The PROMIS Anxiety scale is an 8-item scale that measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater anxiety is indicated by higher scores.
Measured: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
The PROMIS Anxiety scale is an 8-item scale that measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater anxiety is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
The PROMIS Anxiety scale is an 8-item scale that measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater anxiety is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
The PROMIS Depression scale is an 8-item scale that measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater depression is indicated by higher scores.
Measured: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
The PROMIS Depression scale is an 8-item scale that measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater depression is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
The PROMIS Depression scale is an 8-item scale that measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater depression is indicated by higher scores.
Measured: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
The PROMIS Depression scale is an 8-item scale that measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater depression is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
The PROMIS Depression scale is an 8-item scale that measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater depression is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
The PROMIS Psychological Stress scale is an 8-item scale that measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater stress is indicated by higher scores.
Measured: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
The PROMIS Psychological Stress scale is an 8-item scale that measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater stress is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
The PROMIS Psychological Stress scale is an 8-item scale that measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater stress is indicated by higher scores.
Measured: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
The PROMIS Psychological Stress scale is an 8-item scale that measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater stress is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
The PROMIS Psychological Stress scale is an 8-item scale that measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always). Possible total scores range from 8 to 40. Greater stress is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
18-item self-report measure of anxiety sensitivity. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the previous ASIs provided. The ASI-3 will be utilized to assess level of overall anxiety sensitivity. Participants are asked to rate the degree to which anxiety symptoms are distressing on a five-point scale from 0 ("Very Little") to 4 ("Very Much"). Possible total scores range from 0 to 72. Greater distress is indicated by higher scores.
Measured: Baseline, pre-intervention
Anxiety Sensitivity Index 3 (ASI-3)
18-item self-report measure of anxiety sensitivity. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the previous ASIs provided. The ASI-3 will be utilized to assess level of overall anxiety sensitivity. Participants are asked to rate the degree to which anxiety symptoms are distressing on a five-point scale from 0 ("Very Little") to 4 ("Very Much"). Possible total scores range from 0 to 72. Greater distress is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
Anxiety Sensitivity Index 3 (ASI-3)
18-item self-report measure of anxiety sensitivity. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the previous ASIs provided. The ASI-3 will be utilized to assess level of overall anxiety sensitivity. Participants are asked to rate the degree to which anxiety symptoms are distressing on a five-point scale from 0 ("Very Little") to 4 ("Very Much"). Possible total scores range from 0 to 72. Greater distress is indicated by higher scores.
Measured: Immediately after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
18-item self-report measure of anxiety sensitivity. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the previous ASIs provided. The ASI-3 will be utilized to assess level of overall anxiety sensitivity. Participants are asked to rate the degree to which anxiety symptoms are distressing on a five-point scale from 0 ("Very Little") to 4 ("Very Much"). Possible total scores range from 0 to 72. Greater distress is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
18-item self-report measure of anxiety sensitivity. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the previous ASIs provided. The ASI-3 will be utilized to assess level of overall anxiety sensitivity. Participants are asked to rate the degree to which anxiety symptoms are distressing on a five-point scale from 0 ("Very Little") to 4 ("Very Much"). Possible total scores range from 0 to 72. Greater distress is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Intolerance of Uncertainty-12
This scale is a 12-item scale for measuring trait Intolerance of Uncertainty. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future. This scale uses a five-point, Likert-type scale ranging from 1 ("Not at all characteristic of me") to 5 ("Entirely characteristic of me"). Possible total scores range from 12 to 60. Greater uncertainty is indicated by higher scores.
Measured: Baseline, pre-intervention
Intolerance of Uncertainty-12
This scale is a 12-item scale for measuring trait Intolerance of Uncertainty. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future. This scale uses a five-point, Likert-type scale ranging from 1 ("Not at all characteristic of me") to 5 ("Entirely characteristic of me"). Possible total scores range from 12 to 60. Greater uncertainty is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
Intolerance of Uncertainty-12
This scale is a 12-item scale for measuring trait Intolerance of Uncertainty. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future. This scale uses a five-point, Likert-type scale ranging from 1 ("Not at all characteristic of me") to 5 ("Entirely characteristic of me"). Possible total scores range from 12 to 60. Greater uncertainty is indicated by higher scores.
Measured: Immediately after the intervention
Intolerance of Uncertainty-12
This scale is a 12-item scale for measuring trait Intolerance of Uncertainty. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future. This scale uses a five-point, Likert-type scale ranging from 1 ("Not at all characteristic of me") to 5 ("Entirely characteristic of me"). Possible total scores range from 12 to 60. Greater uncertainty is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Intolerance of Uncertainty-12
This scale is a 12-item scale for measuring trait Intolerance of Uncertainty. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future. This scale uses a five-point, Likert-type scale ranging from 1 ("Not at all characteristic of me") to 5 ("Entirely characteristic of me"). Possible total scores range from 12 to 60. Greater uncertainty is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four. Possible total scores range from 0 to 28. Higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: Baseline, pre-intervention
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four. Possible total scores range from 0 to 28. Higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: Immediately after the intervention
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four. Possible total scores range from 0 to 28. Higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: Follow-Up, 1 month after the intervention
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four. Possible total scores range from 0 to 28. Higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: Follow-Up, 3 months after the intervention
Depressive Symptom Index - Suicidality Subscale (DSI-SS)
The DSI-SS is a 4-item measure of symptoms of suicide. The DSI-SS was designed to be a brief screening measure for suicide risk, and has well established cut points for clinical and research utility. Participants are asked to rate each item using a scale that ranges from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation.
Measured: Baseline, pre-intervention
Depressive Symptom Index - Suicidality Subscale (DSI-SS)
The DSI-SS is a 4-item measure of symptoms of suicide. The DSI-SS was designed to be a brief screening measure for suicide risk, and has well established cut points for clinical and research utility. Participants are asked to rate each item using a scale that ranges from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation.
Measured: Immediately after the intervention
Depressive Symptom Index - Suicidality Subscale (DSI-SS)
The DSI-SS is a 4-item measure of symptoms of suicide. The DSI-SS was designed to be a brief screening measure for suicide risk, and has well established cut points for clinical and research utility. Participants are asked to rate each item using a scale that ranges from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation.
Measured: Follow-Up, 1 month after the intervention
Depressive Symptom Index - Suicidality Subscale (DSI-SS)
The DSI-SS is a 4-item measure of symptoms of suicide. The DSI-SS was designed to be a brief screening measure for suicide risk, and has well established cut points for clinical and research utility. Participants are asked to rate each item using a scale that ranges from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation.
Measured: Follow-Up, 3 months after the intervention
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior. For items 1-8, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 9 and 10, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 40. Greater alcohol consumption, drinking behavior, and alcohol-related problems is indicated by higher scores.
Measured: Baseline, pre-intervention
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior. For items 1-8, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 9 and 10, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 40. Greater alcohol consumption, drinking behavior, and alcohol-related problems is indicated by higher scores.
Measured: Immediately after the intervention
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior. For items 1-8, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 9 and 10, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 40. Greater alcohol consumption, drinking behavior, and alcohol-related problems is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior. For items 1-8, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 9 and 10, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 40. Greater alcohol consumption, drinking behavior, and alcohol-related problems is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Drug Use Disorders Identification Test (DUDIT)
The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior. For items 1-9, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 10 and 11, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 44. Greater drug consumption, drug use behavior, and drug-related problems is indicated by higher scores.
Measured: Baseline, pre-intervention
Drug Use Disorders Identification Test (DUDIT)
The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior. For items 1-9, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 10 and 11, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 44. Greater drug consumption, drug use behavior, and drug-related problems is indicated by higher scores.
Measured: Immediately after the intervention
Drug Use Disorders Identification Test (DUDIT)
The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior. For items 1-9, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 10 and 11, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 44. Greater drug consumption, drug use behavior, and drug-related problems is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Drug Use Disorders Identification Test (DUDIT)
The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior. For items 1-9, participants are asked to rate each item using a scale that ranges from 0 to 4. For items 10 and 11, participants are asked to choose from possible responses of 0, 2 and 4. Possible total scores range from 0 to 44. Greater drug consumption, drug use behavior, and drug-related problems is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Fear of Arousal Questionnaire (FAQ)
The FAQ is a 12-item self-report measure of fear of arousal. Fear of arousal is defined as the fear of the physiological responses that are typical of anxiety (e.g., racing thoughts, racing heart, or throat tightening). The measure asks participants to rate each item on a 1 to 5 scale with 1 corresponding to no anxiety and 5 corresponding to extreme anxiety. Possible total scores range from 12 to 60. Greater fear of arousal is indicated by higher scores.
Measured: Baseline, pre-intervention
Fear of Arousal Questionnaire (FAQ)
The FAQ is a 12-item self-report measure of fear of arousal. Fear of arousal is defined as the fear of the physiological responses that are typical of anxiety (e.g., racing thoughts, racing heart, or throat tightening). The measure asks participants to rate each item on a 1 to 5 scale with 1 corresponding to no anxiety and 5 corresponding to extreme anxiety. Possible total scores range from 12 to 60. Greater fear of arousal is indicated by higher scores.
Measured: Immediately after the intervention
Fear of Arousal Questionnaire (FAQ)
The FAQ is a 12-item self-report measure of fear of arousal. Fear of arousal is defined as the fear of the physiological responses that are typical of anxiety (e.g., racing thoughts, racing heart, or throat tightening). The measure asks participants to rate each item on a 1 to 5 scale with 1 corresponding to no anxiety and 5 corresponding to extreme anxiety. Possible total scores range from 12 to 60. Greater fear of arousal is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
Fear of Arousal Questionnaire (FAQ)
The FAQ is a 12-item self-report measure of fear of arousal. Fear of arousal is defined as the fear of the physiological responses that are typical of anxiety (e.g., racing thoughts, racing heart, or throat tightening). The measure asks participants to rate each item on a 1 to 5 scale with 1 corresponding to no anxiety and 5 corresponding to extreme anxiety. Possible total scores range from 12 to 60. Greater fear of arousal is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
National Institutes of Health (NIH) Toolbox Loneliness Scale
The NIH Toolbox Loneliness Scale is a 5-item scale belonging to the NIH Toolbox Adult Social Relationship Scales. This brief scale was developed to measure perceived loneliness, or the perception that one is lonely or socially isolated from others. The measure asks participants to rate each item on a 1 ("Never") to 5 ("Always") scale. Possible total scores range from 5 to 25. Greater loneliness is indicated by higher scores.
Measured: Baseline, pre-intervention
National Institutes of Health (NIH) Toolbox Loneliness Scale
The NIH Toolbox Loneliness Scale is a 5-item scale belonging to the NIH Toolbox Adult Social Relationship Scales. This brief scale was developed to measure perceived loneliness, or the perception that one is lonely or socially isolated from others. The measure asks participants to rate each item on a 1 ("Never") to 5 ("Always") scale. Possible total scores range from 5 to 25. Greater loneliness is indicated by higher scores.
Measured: During the Intervention (Weeks 1-5)
National Institutes of Health (NIH) Toolbox Loneliness Scale
The NIH Toolbox Loneliness Scale is a 5-item scale belonging to the NIH Toolbox Adult Social Relationship Scales. This brief scale was developed to measure perceived loneliness, or the perception that one is lonely or socially isolated from others. The measure asks participants to rate each item on a 1 ("Never") to 5 ("Always") scale. Possible total scores range from 5 to 25. Greater loneliness is indicated by higher scores.
Measured: Immediately after the intervention
National Institutes of Health (NIH) Toolbox Loneliness Scale
The NIH Toolbox Loneliness Scale is a 5-item scale belonging to the NIH Toolbox Adult Social Relationship Scales. This brief scale was developed to measure perceived loneliness, or the perception that one is lonely or socially isolated from others. The measure asks participants to rate each item on a 1 ("Never") to 5 ("Always") scale. Possible total scores range from 5 to 25. Greater loneliness is indicated by higher scores.
Measured: Follow-Up, 1 month after the intervention
National Institutes of Health (NIH) Toolbox Loneliness Scale
The NIH Toolbox Loneliness Scale is a 5-item scale belonging to the NIH Toolbox Adult Social Relationship Scales. This brief scale was developed to measure perceived loneliness, or the perception that one is lonely or socially isolated from others. The measure asks participants to rate each item on a 1 ("Never") to 5 ("Always") scale. Possible total scores range from 5 to 25. Greater loneliness is indicated by higher scores.
Measured: Follow-Up, 3 months after the intervention
Exit Interview
Participants will provide information on how to tailor the intervention, including the order of the components, the amount of homework specific to each component, and the length of time before the booster session to best meet their needs. They will provide this information in a focused feedback session in which they will respond to an investigator-created semi-structured interview.
Measured: Immediately after the intervention
Ecological Momentary Assessment (EMA) questions
The EMA items include several investigator designed questions asking participants about the impact of the COVID-19 pandemic, sleep quality, and in-the-moment ratings of anxiety, depression, stress, and loneliness. These are the items that participants will complete every morning. Participants will then be asked to rate in-the-moment anxiety, depression, stress, and loneliness and 3 random points throughout the day. Following week 1, participants will receive prompts about coping with anxiety, stress, uncertainty, and loneliness. Following week 1, participants will also be asked to engage in interoceptive exposure exercises, Intolerance of uncertainty exercises, and loneliness exercises. Participants will be asked to describe their experience of engaging in the exercises using the MetricWire app.
Measured: During the Intervention (Weeks 1-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Allan, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019053
- Sponsor's protocol ID
- BAKER_Coping Crew Intervention
- Acronym
- COPING CREW
- Status last verified
- Feb 2022
- First submitted
- 29 Jul 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sher L. The impact of the COVID-19 pandemic on suicide rates. QJM. 2020 Oct 1;113(10):707-712. doi: 10.1093/qjmed/hcaa202.
PubMed 32539153Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
PubMed 32790653Mohr DC, Hart SL, Howard I, Julian L, Vella L, Catledge C, Feldman MD. Barriers to psychotherapy among depressed and nondepressed primary care patients. Ann Behav Med. 2006 Dec;32(3):254-8. doi: 10.1207/s15324796abm3203_12.
PubMed 17107299Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Barriers to Mental Health Treatment in Rural Older Adults. Am J Geriatr Psychiatry. 2015 Nov;23(11):1172-8. doi: 10.1016/j.jagp.2015.06.002. Epub 2015 Jun 17.
PubMed 26245880Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, Reifler D. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010 Apr;66(4):394-409. doi: 10.1002/jclp.20659.
PubMed 20127795DeMartini KS, Carey KB. The role of anxiety sensitivity and drinking motives in predicting alcohol use: a critical review. Clin Psychol Rev. 2011 Feb;31(1):169-77. doi: 10.1016/j.cpr.2010.10.001. Epub 2010 Oct 21.
PubMed 21074306McClelland H, Evans JJ, Nowland R, Ferguson E, O'Connor RC. Loneliness as a predictor of suicidal ideation and behaviour: a systematic review and meta-analysis of prospective studies. J Affect Disord. 2020 Sep 1;274:880-896. doi: 10.1016/j.jad.2020.05.004. Epub 2020 May 22.
PubMed 32664029Allan NP, Macatee RJ, Norr AM, Raines AM, Schmidt NB. Relations between common and specific factors of anxiety sensitivity and distress tolerance and fear, distress, and alcohol and substance use disorders. J Anxiety Disord. 2015 Jun;33:81-9. doi: 10.1016/j.janxdis.2015.05.002. Epub 2015 May 21.
PubMed 26037492Allan NP, Capron DW, Raines AM, Schmidt NB. Unique relations among anxiety sensitivity factors and anxiety, depression, and suicidal ideation. J Anxiety Disord. 2014 Mar;28(2):266-75. doi: 10.1016/j.janxdis.2013.12.004. Epub 2013 Dec 27.
PubMed 24534564Allan NP, Albanese BJ, Norr AM, Zvolensky MJ, Schmidt NB. Effects of anxiety sensitivity on alcohol problems: evaluating chained mediation through generalized anxiety, depression and drinking motives. Addiction. 2015 Feb;110(2):260-8. doi: 10.1111/add.12739. Epub 2014 Oct 23.
PubMed 25220033Banducci AN, Bujarski SJ, Bonn-Miller MO, Patel A, Connolly KM. The impact of intolerance of emotional distress and uncertainty on veterans with co-occurring PTSD and substance use disorders. J Anxiety Disord. 2016 Jun;41:73-81. doi: 10.1016/j.janxdis.2016.03.003. Epub 2016 Mar 9.
PubMed 27004450Allan NP, Boffa JW, Raines AM, Schmidt NB. Intervention related reductions in perceived burdensomeness mediates incidence of suicidal thoughts. J Affect Disord. 2018 Jul;234:282-288. doi: 10.1016/j.jad.2018.02.084. Epub 2018 Feb 27.
PubMed 29554617Oglesby ME, Allan NP, Schmidt NB. Randomized control trial investigating the efficacy of a computer-based intolerance of uncertainty intervention. Behav Res Ther. 2017 Aug;95:50-57. doi: 10.1016/j.brat.2017.05.007. Epub 2017 May 11.
PubMed 28531873Raines AM, Allan NP, McGrew SJ, Gooch CV, Wyatt M, Laurel Franklin C, Schmidt NB. A computerized anxiety sensitivity intervention for opioid use disorders: A pilot investigation among veterans. Addict Behav. 2020 May;104:106285. doi: 10.1016/j.addbeh.2019.106285. Epub 2020 Jan 7.
PubMed 32006788Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.
PubMed 24821096
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability/Feasibility of COVID-19 Intervention of a Virtual Group Intervention for COVID-19 Distress
- ClinicalTrials.gov ID
- NCT05019053
- Acronym / sponsor ID
- COPING CREW / BAKER_Coping Crew Intervention
- Conditions
- Social Isolation, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll, 45% of respondents reported that the coronavirus has had a negative impact on their mental health. This is reflected in Southeastern Ohio. In data that the investigators collected from 317 Ohio University faculty, staff, and students from late May to early June, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severe levels of depression and 57% reported the COVID-19 outbreak was impacting their sense of social connection much or very much. Despite the significant community need for accessible and affordable care, there are currently no evidence-based interventions for individuals coping poorly with coronavirus-related distress. The investigators have developed a virtual group-based intervention targeting cognitive biases that amplify the experience of stress and anxiety (i.e., amplifying cognitions; Coping with Coronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing this intervention in a scientifically rigorous manner is to refine the manual and procedures and conduct a pilot test of the intervention.
Detailed description
There is a coming mental health crisis in response to the COVID-19 pandemic. Already, rates of depression, anxiety, and suicide are elevated in response to the pandemic. A recent study of more than 5,400 people in the US found prevalence rates of anxiety and depression in June of 2020 were 3-4 times higher than these rates in June of 2019. In this same study, 41% of respondents in June 2020 reported experiencing an adverse mental or behavioral health condition, including 13% who endorsed using substances to cope with stress or emotions and 11% who reported seriously contemplating suicide in the prior 30 days. Thus, heightened anxiety, stress, and depression will likely continue to lead to increases in self-harm and maladaptive substance use if left unchecked.
It is crucial that empirically validated psychotherapies be developed to meet these needs. These treatments must address how common barriers to treatment, including time, cost, transportation, and stigma about mental health may be exacerbated by the pandemic. The investigators developed a brief, virtual group-based intervention, framed as educational, Coping with Coronavirus-Related Emotions and Worries (COPING CREW), to address these barriers. This intervention was developed over the summer by Drs. Allan, Suhr, and Austin, working with two graduate student research assistants for administration by clinical psychology graduate student therapists as part of their practicum experience at the Ohio University Psychology and Social Work Clinic (PSWC). A benefit of this approach, therefore, is that this intervention is highly scalable.
Theoretical models posit the short- and long-term stressors experienced during the pandemic exacerbate the experience of negative emotions an individual is already predisposed to experience. That is, people who are already experiencing mental health issues are going to experience more severe issues and people who may not already be experiencing mental health issues are more likely to develop mental health issues during the pandemic. Cognitive risk factors (i.e., amplifying cognitions) such as anxiety sensitivity (fear of anxiety sensations), intolerance of uncertainty (fear of the unknown), and loneliness (the subjective feeling of isolation) increase the experience of negative emotions as well as the likelihood of unhealthy coping behavior such as increased alcohol consumption or self-harm.
Anxiety sensitivity, intolerance of uncertainty, and loneliness can be reduced through brief interventions applying cognitive-behavioral therapy principles. Reductions in these constructs lead to later reductions in anxiety, depression, and suicide. Targeting these risk factors appears critical to address distress due to COVID-19. In 317 Ohio University faculty, staff, and students, anxiety sensitivity, intolerance of uncertainty, and loneliness accounted for 63%-75% of the variance in ratings of anxiety, depression, and suicidality as well as 49% of COVID-related disability. These findings highlight the prominent role these risk factors play in the distress many individuals are experiencing due to COVID-19. The investigators have developed a virtual group-based intervention targeting risk factors that amplify the experience of emotional distress; the next steps in developing a scientifically rigorous intervention that can be disseminated broadly is to develop and pilot test this intervention.
The goals specific to this project are to 1) engage stakeholders in the design of a brief group-based treatment to improve COPING CREW and 2) to conduct a Stage I pilot trial through evaluating the acceptability and feasibility of COPING CREW.
Aim 1: Refine a prototype for COPING CREW by working virtually with a community partner stakeholder advisory group (SAG) as well as participants receiving the intervention. The investigators will develop a SAG comprising one participant from each community partner. The investigators will meet with the SAG at least three times during the 1-year project. Meetings will occur prior to starting COPING CREW groups, after running the first two groups, and after all four groups have been completed. The investigators anticipate that building a strong relationship with this SAG will increase treatment relevance to clientele, treatment engagement, and treatment dissemination. In turn, this will enhance the durable impacts and sustainability of COPING CREW. In addition to SAGs, the investigators will also utilize a systematic approach to engage with participant stakeholders by asking for feedback about the intervention (the Exit Interview). The investigators have used these intervention modules separately a number of times but have yet to examine these modules as part of the same intervention. Thus, participants will provide important information on how to tailor the intervention, including the order of the components, the amount of homework specific to each component, and the length of time before the booster session to best meet their needs. Although the investigators are confident that COPING CREW will largely be viewed as acceptable, it can be modified to increase acceptability by effective engagement with community partners. Solicitation of feedback will occur via two mechanisms. First, information related to adaptation will be obtained from quantitative and qualitative feedback during the intervention. Second, information related to adaptation and engagement will also be collected in separate, focused feedback sessions with COPING CREW participants.
Aim 2: Examine acceptability and feasibility of COPING CREW, delivered virtually. A pilot one arm trial will be conducted, delivering the intervention to 24 participants across 4 groups.
H1: It is hypothesized that the intervention will demonstrate high acceptability and feasibility (as measured by completion rates and favorable ratings of satisfaction) across intervention modules and components within sessions. Components will include psychoeducation, challenging cognitive biases or mythbusting, behavioral exposure, behavioral experiments, and ecological momentary intervention (EMI) for treatment monitoring and homework tracking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coping Crew Intervention | Experimental | Behavioral: Coping CrewInterested participants who meet the screening criteria will be assigned to receive COPING CREW. First, following informed consent, eligible participants will complete a baseline assessment appointment in the week prior to the group beginning. During the baseline appointment, participants will provide informed consent, be instructed in the use of Microsoft Teams, complete a battery of self-report measures, be given a semi-structured diagnostic interview, and follow instructions to install a mobile app that will be used to track their mood and homework. Then, 4 groups of COPING CREW, with 6 participants per group, will be run. Participants will complete four weekly 60-minute virtual intervention sessions followed by a booster session two weeks later. Participants will complete daily surveys and homework assignments on their mobile devices. Links to follow-up surveys will be sent to participants at 1- and 3-month follow-ups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elevated anxiety sensitivity (i.e., a score greater than 1 standard deviation above the mean on the Anxiety Sensitivity Index-3; Taylor et al., 2007)
- Elevated Intolerance of uncertainty (i.e., a score greater than 1 standard deviation above the mean on the Intolerance of Uncertainty Scale - Short Form; Carleton et al., 2007)
- Elevated loneliness (i.e., a score greater than 1 standard deviation above the mean on the NIH Toolbox Loneliness Scale; Cyranowski et al., 2013)
- Access to a device with internet connection
Key exclusion criteria (1 listed)
- Participants who have previously received other FEAR Lab interventions or participated in a focus group related to that intervention (20-X-184; 20-X-204) will be excluded due to the overlap of intervention material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping CrewCoping Crew consists of five 60-minute virtual intervention sessions coinciding with five weeks of EMI. Participants will receive psychoeducation, challenge cognitive biases or mythbust, and participate in behavioral exposure and behavioral experiments. An EMI component of this treatment will be included for the purpose of treatment monitoring and homework tracking. Participation in this EMI component involves the daily report of levels of anxiety, depression, stress, and loneliness. When participants endorse elevated levels on any of these constructs, they will receive a targeted message reminding them of the topics covered in COPING CREW. One month after the intervention session, COPING CREW participants will complete follow-up questionnaires and interview. Participants will also participate in a feedback session 3 months after the intervention. | Behavioural | Coping Crew Intervention |
Primary outcome
Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8
Time frame: Immediately after the intervention
The Client Satisfaction Questionnaire-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The Client Satisfaction Questionnaire-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale. Possible total scores range from 8 to 32. Greater satisfaction is indicated by higher scores.
Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention
Time frame: 5-week EMA/EMI, During the Intervention (Weeks 1-5)
Feasibility will also be determined based on response rates for Ecological Momentary Assessment/Ecological Momentary Intervention. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery.
65 secondary outcomes
COVID-19 Impact Battery - Behavior
Time frame: Baseline, pre-intervention
COVID-19 Impact Battery - Behavior
Time frame: Immediately after the intervention
COVID-19 Impact Battery - Behavior
Time frame: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Behavior
Time frame: Follow-Up, 3 months after the intervention
COVID-19 Impact Battery - Worry
Time frame: Baseline, pre-intervention
COVID-19 Impact Battery - Worry
Time frame: Immediately after the intervention
COVID-19 Impact Battery - Worry
Time frame: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Worry
Time frame: Follow-Up, 3 months after the intervention
COVID-19 Impact Battery - Disability
Time frame: Baseline, pre-intervention
COVID-19 Impact Battery - Disability
Time frame: Immediately after the intervention
COVID-19 Impact Battery - Disability
Time frame: Follow-Up, 1 month after the intervention
COVID-19 Impact Battery - Disability
Time frame: Follow-Up, 3 months after the intervention
COVID-19 Items
Time frame: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
Time frame: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
Time frame: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
Time frame: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
Time frame: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
Time frame: Follow-Up, 3 months after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
Time frame: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
Time frame: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
Time frame: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
Time frame: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
Time frame: Follow-Up, 3 months after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
Time frame: Baseline, pre-intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
Time frame: During the Intervention (Weeks 1-5)
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
Time frame: Immediately after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
Time frame: Follow-Up, 1 month after the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
Time frame: Follow-Up, 3 months after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: Baseline, pre-intervention
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: During the Intervention (Weeks 1-5)
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: Immediately after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: Follow-Up, 1 month after the intervention
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: Follow-Up, 3 months after the intervention
Intolerance of Uncertainty-12
Time frame: Baseline, pre-intervention
Intolerance of Uncertainty-12
Time frame: During the Intervention (Weeks 1-5)
Intolerance of Uncertainty-12
Time frame: Immediately after the intervention
Intolerance of Uncertainty-12
Time frame: Follow-Up, 1 month after the intervention
Intolerance of Uncertainty-12
Time frame: Follow-Up, 3 months after the intervention
Insomnia Severity Index (ISI)
Time frame: Baseline, pre-intervention
Insomnia Severity Index (ISI)
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 32539153Sher L. The impact of the COVID-19 pandemic on suicide rates. QJM. 2020 Oct 1;113(10):707-712. doi: 10.1093/qjmed/hcaa202.
- Background: PubMed 32790653Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
- Background: PubMed 17107299Mohr DC, Hart SL, Howard I, Julian L, Vella L, Catledge C, Feldman MD. Barriers to psychotherapy among depressed and nondepressed primary care patients. Ann Behav Med. 2006 Dec;32(3):254-8. doi: 10.1207/s15324796abm3203_12.
- Background: PubMed 26245880Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Barriers to Mental Health Treatment in Rural Older Adults. Am J Geriatr Psychiatry. 2015 Nov;23(11):1172-8. doi: 10.1016/j.jagp.2015.06.002. Epub 2015 Jun 17.
- Background: PubMed 20127795Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, Reifler D. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010 Apr;66(4):394-409. doi: 10.1002/jclp.20659.
- Background: PubMed 21074306DeMartini KS, Carey KB. The role of anxiety sensitivity and drinking motives in predicting alcohol use: a critical review. Clin Psychol Rev. 2011 Feb;31(1):169-77. doi: 10.1016/j.cpr.2010.10.001. Epub 2010 Oct 21.
- Background: PubMed 32664029McClelland H, Evans JJ, Nowland R, Ferguson E, O'Connor RC. Loneliness as a predictor of suicidal ideation and behaviour: a systematic review and meta-analysis of prospective studies. J Affect Disord. 2020 Sep 1;274:880-896. doi: 10.1016/j.jad.2020.05.004. Epub 2020 May 22.
- Background: PubMed 26037492Allan NP, Macatee RJ, Norr AM, Raines AM, Schmidt NB. Relations between common and specific factors of anxiety sensitivity and distress tolerance and fear, distress, and alcohol and substance use disorders. J Anxiety Disord. 2015 Jun;33:81-9. doi: 10.1016/j.janxdis.2015.05.002. Epub 2015 May 21.
- Background: PubMed 24534564Allan NP, Capron DW, Raines AM, Schmidt NB. Unique relations among anxiety sensitivity factors and anxiety, depression, and suicidal ideation. J Anxiety Disord. 2014 Mar;28(2):266-75. doi: 10.1016/j.janxdis.2013.12.004. Epub 2013 Dec 27.
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- Background: PubMed 27004450Banducci AN, Bujarski SJ, Bonn-Miller MO, Patel A, Connolly KM. The impact of intolerance of emotional distress and uncertainty on veterans with co-occurring PTSD and substance use disorders. J Anxiety Disord. 2016 Jun;41:73-81. doi: 10.1016/j.janxdis.2016.03.003. Epub 2016 Mar 9.
- Background: PubMed 29554617Allan NP, Boffa JW, Raines AM, Schmidt NB. Intervention related reductions in perceived burdensomeness mediates incidence of suicidal thoughts. J Affect Disord. 2018 Jul;234:282-288. doi: 10.1016/j.jad.2018.02.084. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Crew in people with Social Isolation and Emotional Disorder, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Allan, Ph.D. (740-597-2717, allan@ohio.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8 (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019053, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.