Generalized Anxiety DisorderCLUENCT05172427
Acceptability/Feasibility of IU Intervention
A study testing 14 days of EMI and Uncertainty reappraisal training in people with Generalized Anxiety Disorder and Emotional Disorder, run by Ohio University at 1 site in United States.
Trial summary
Anxiety disorders are prominent mental health burdens, affecting roughly 1 in 5 adults annually, and a third of individuals over the course of their life. These disorders are also impairing to individuals, with 23% of individuals with anxiety disorders describing their impairment as serious. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, Emotional Disorder
- What is being tested?
- 14 days of EMI and Uncertainty reappraisal training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 31 Dec 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 GAD symptoms (i.e., GAD-7 scores greater than or equal to 10)
- Elevated IU symptoms (i.e., IUS-12 scores greater than or equal to 28)
- Access to a device with internet connection
Who cannot join
- N/A
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 Testing of an Intervention Targeting Intolerance of Uncertainty
Anxiety disorders are prominent mental health burdens, affecting roughly 1 in 5 adults annually, and a third of individuals over the course of their life. These disorders are also impairing to individuals, with 23% of individuals with anxiety disorders describing their impairment as serious. Given the public health impact, it is crucial that interventions are designed to alleviate symptoms of anxiety, through reducing risk factors that predispose individuals to develop anxiety. One approach to do this is to develop brief interventions that could be administered virtually, which can then be supplemented using ecological momentary intervention (EMI) to reduce risk factors for anxiety disorders. In contrast to targeting more distant risk factors, targeting more direct risk factors, such as intolerance of uncertainty, could be used in the prevention and treatment of anxiety disorders.
Read the detailed description
Anxiety disorders have been estimated to impact roughly 1 in 5 (19%) adults in the United States over the past year, and almost a third (31%) of adults in the United States over the course of their life. Further, these disorders are impairing to individuals; 23% of individuals with anxiety disorders describing their impairment as serious. Given this public health impact, it is crucial, that interventions are designed to alleviate symptoms of anxiety, or to reduce risk factors that may predispose individuals to develop anxiety. Further, it is expected that the COVID-19 will have long-lasting impacts on mental concerns worldwide. With these concerns come new opportunities to improve mental health care, through ultra-brief, self-paced, web-based interventions. These interventions are ideal to increase access to care given their high dissemination value and low cost. Building on prior experimental and intervention work conducted by Dr. Allan, we aim to conduct pilot testing of an ultra-brief, CBT-informed intervention targeting intolerance of uncertainty, or an extreme aversion to and fear of uncertainty.
Intolerance of uncertainty is an ideal construct to target in a broad web-based intervention given theoretical and empirical links between intolerance of uncertainty and a broad spectrum of anxiety and related disorders. Theoretically, intolerance of uncertainty amplifies the experience of stress and anxiety causing people to engage in maladaptive cognitive (e.g., worry) and behavioral (e.g., checking, avoidance) strategies to reduce distress, preventing an opportunity to habituate to the uncertainty. Empirically, a recent meta-analysis reported effect sizes (ds) ranging from .4 to .6 across generalized anxiety disorder, major depression, obsessive compulsive disorder, social anxiety disorder, panic disorder and agoraphobia, and eating disorders. Other studies have implicated intolerance of uncertainty in posttraumatic stress disorder as well as suicidal thought and behavior. More recent evidence has demonstrated that intolerance of uncertainty is not only a "fundamental fear" underlying anxiety disorder etiology but has also been implicated in a host of other mental health problems, including substance use. We recently examined the impact of intolerance of uncertainty on anxiety and depression during the COVID-19 pandemic over three months and found intolerance of uncertainty was concurrently associated with and significantly predictive of symptoms of generalized anxiety disorder and depression. Therefore, not only is there strong theoretical and empirical support for intolerance of uncertainty as a transdiagnostic risk factor for anxiety and related conditions, but there is also evidence that supports intolerance of uncertainty as particularly relevant to the current environmental conditions due to COVID-19.
To date, we have conducted the only pilot RCT of a CBT-based intervention (clinicaltrials.gov NCT04199884). In a sample of 84 participants with elevated intolerance of uncertainty during their screening appointment, we compared a researcher-facilitated Intolerance of Uncertainty Treatment (IUT) to a time-matched healthy living control condition. IUT contains psychoeducation, challenging negative automatic thoughts regarding uncertainty through "mythbusting" exercises, and designing behavioral experiments to challenge these negative automatic thoughts. In this study, significant, medium effect size differences (d = .46) emerged between IUT and the control condition, but not until the month 1 follow-up. In addition, reductions in intolerance of uncertainty served as indirect effects from treatment condition to anxiety and depression symptoms. Further, most people found the intervention easy to understand, helpful, and applicable to their daily lives. Building on this prior work, we plan to adapt the existing ultra-brief intolerance of uncertainty intervention to be disseminated via a web-based computerized platform. Given the flexibility afforded via this digital platform, we also propose to include ecological momentary intervention (EMI) to enhance learning through the application of critical interventions skills as needed. EMI is ideal for these brief interventions as it allows for participants to gain the much-needed practice of challenging negative automatic thoughts and completing behavioral experiments critical to internalizing the skills and strategies taught during the intervention. Similar augmentations to brief interventions for stress, generalized anxiety disorder, and panic disorder (d = .5) have been successful in enhancing intervention effects (i.e., an additional d of .4 to .6), further underscoring the promise of including EMI to optimize outcomes.
The goals specific to this project are to 1) engage stakeholders in the design of an ultra-brief intolerance of uncertainty intervention (Enhanced Intolerance of Uncertainty Treatment [E-IUT]) and 2) to conduct a pilot trial to evaluate the acceptability, feasibility, and preliminary effect size estimates of E-IUT, in support of a larger fully powered test of E-IUT.
- Conditions
- Generalized Anxiety Disorder, Emotional Disorder
- Being tested
- 14 days of EMI, Uncertainty reappraisal training
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 days of EMIBehavioural
Following the intervention, participants will receive personalized prompts whenever they report elevated stress or anxiety. These prompts will be generated at the end of the intervention session, and will only be sent to individuals in the EMI condition.
Uncertainty reappraisal trainingBehavioural
CLUE consists of an hour long intervention, followed by a 2-week long EMI. During the hour long intervention session, participants will receive psychoeducation (i.e., defining uncertainty), discuss myths associated with uncertainty (e.g., if I do not plan things, they will go poorly), and discuss behavioral experiments that can be done to challenge uncertainty beliefs.
| Study group | Role | What they receive |
|---|---|---|
| CLUE intervention (EMA + EMI) | Active comparator | Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA, which will include EMI prompts that they come up with at the end of the CLUE intervention (framed as "key takeaways"). After the two week period of EMA/EMI, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention. Receives: Behavioral: 14 days of EMI; Behavioral: Uncertainty reappraisal training |
| CLUE intervention (EMA only) | Active comparator | Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention. Receives: Behavioral: Uncertainty reappraisal training |
| Waitlist control | No intervention | Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, participants will be assigned 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline. One month after the post-intervention questionnaires, participants will complete a one-month follow up questionnaire battery, that will include parallel questions from baseline and post-intervention. As these participants did not receive the intervention following their baseline EMA, they will be given the opportunity to schedule an appointment for the intervention after they have completed their one-month follow up questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire-8
The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale
Measured: One day after 14-day EMA/EMI
Client Satisfaction Questionnaire-8
The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale
Measured: One month follow up
Feasibility of service
Feasibility will also be determined based on response rates for EMA/EMI. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery
Measured: 14-day EMA/EMI
Secondary outcomes (53)
Intolerance of Uncertainty-12
a 12-item scale for measuring trait IU. 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.
Measured: Baseline
Intolerance of Uncertainty-12
a 12-item scale for measuring trait IU. 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.
Measured: One day after 14-day EMA/EMI
Intolerance of Uncertainty-12
a 12-item scale for measuring trait IU. 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.
Measured: One month follow up
PROMIS anxiety scale
The PROMIS Anxiety scale 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).
Measured: Baseline
PROMIS anxiety scale
The PROMIS Anxiety scale 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).
Measured: One day after 14-day EMA/EMI
PROMIS anxiety scale
The PROMIS Anxiety scale 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).
Measured: One month follow up
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Measured: Baseline
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Measured: One day after 14-day EMA/EMI
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Measured: One month follow up
PROMIS stress scale
The PROMIS Psychological Stress scale 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).
Measured: Baseline
PROMIS stress scale
The PROMIS Psychological Stress scale 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).
Measured: One day after 14-day EMA/EMI
PROMIS stress scale
The PROMIS Psychological Stress scale 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).
Measured: One month follow up
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.
Measured: Baseline
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.
Measured: One day after 14-day EMA/EMI
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.
Measured: One month follow up
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.
Measured: Baseline
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.
Measured: One day after 14-day EMA/EMI
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.
Measured: One month follow up
COVID-19 impact battery short-form (CIB-SF)
A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
Measured: Baseline
COVID-19 impact battery short-form (CIB-SF)
A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
Measured: One day after 14-day EMA/EMI
COVID-19 impact battery short-form (CIB-SF)
A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
Measured: One month follow up
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Measured: Baseline
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Measured: One day after 14-day EMA/EMI
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Measured: One month follow up
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, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: Baseline
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, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: One day after 14-day EMA/EMI
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, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.
Measured: One month follow up
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).
Measured: Baseline
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).
Measured: One day after 14-day EMA/EMI
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).
Measured: One month follow up
The Anxiety Depression Distress Inventory-27 (ADDI-27)
The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).
Measured: Baseline
The Anxiety Depression Distress Inventory-27 (ADDI-27)
The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).
Measured: One day after 14-day EMA/EMI
The Anxiety Depression Distress Inventory-27 (ADDI-27)
The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).
Measured: One month follow up
Perseverative Thought Questionnaire (PTQ)
The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).
Measured: Baseline
Perseverative Thought Questionnaire (PTQ)
The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).
Measured: One day after 14-day EMA/EMI
Perseverative Thought Questionnaire (PTQ)
The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).
Measured: One month follow up
Ruminative Response Scale (RRS)
The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").
Measured: Baseline
Ruminative Response Scale (RRS)
The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").
Measured: One day after 14-day EMA/EMI
Ruminative Response Scale (RRS)
The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").
Measured: One month follow up
Positive and Negative Affect Schedule-SF
The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.
Measured: Baseline
Positive and Negative Affect Schedule-SF
The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.
Measured: One day after 14-day EMA/EMI
Positive and Negative Affect Schedule-SF
The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.
Measured: One month follow up
The Metacognition Questionnaire-30 (MCQ)
The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),
Measured: Baseline
The Metacognition Questionnaire-30 (MCQ)
The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),
Measured: One day after 14-day EMA/EMI
The Metacognition Questionnaire-30 (MCQ)
The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),
Measured: One month follow up
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Measured: Baseline
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Measured: One day after 14-day EMA/EMI
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Measured: One month follow up
Oxford Covid-19 Vaccine Hesitancy Scale
The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
Measured: Baseline
Oxford Covid-19 Vaccine Hesitancy Scale
The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
Measured: One day after 14-day EMA/EMI
Oxford Covid-19 Vaccine Hesitancy Scale
The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
Measured: One month follow up
EMA questions
EMA questions will be given 4 times per day in a 12 hour period. The first survey ("Morning survey") will be a survey that takes approximately 3 minutes to complete. The following surveys ("afternoon surveys") will take approximately a minute to complete. In the 14 day EMA/EMI period, those in the CLUE + EMI condition will receive intervention prompts based on their responses. For those in the CLUE and waitlist control condition, they will not receive intervention prompts based on their responses.
Measured: 7-day EMA period
EMA questions
EMA questions will be given 4 times per day in a 12 hour period. The first survey ("Morning survey") will be a survey that takes approximately 3 minutes to complete. The following surveys ("afternoon surveys") will take approximately a minute to complete. In the 14 day EMA/EMI period, those in the CLUE + EMI condition will receive intervention prompts based on their responses. For those in the CLUE and waitlist control condition, they will not receive intervention prompts based on their responses.
Measured: 14-day EMA/EMI period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two active conditions or a waitlist control condition. Participants assigned to the EMA/EMI condition will receive the intervention, following by two weeks of EMA with personalized EMI prompts sent to them based on their responses to the EMA questions. Participants assigned to the EMA condition will receive the intervention, followed by two weeks of EMA only (with no EMI prompts based on their responses). The waitlist control will not receive the intervention prior to completing two weeks of EMA, and will not receive EMI prompts based on their responses. Those in the waitlist control will be given the opportunity to receive the intervention at their one-month follow up appointment.
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT05172427
- Sponsor's protocol ID
- BARLOW_CLUE intervention
- Acronym
- CLUE
- Status last verified
- Dec 2021
- First submitted
- 8 Sep 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harvard Medical School, 2007. National Comorbidity Survey (NCS). (2017, August 21). Retrieved from https://www.hcp.med.harvard.edu/ncs/index.php. Data Table 2: 12-month prevalence DSM-IV/WMH-CIDI disorders by sex and cohort.
Oglesby 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 28531873Shapiro, M. O., Allan, N. P., & Schmidt, N. B. (under review). A randomized control trial examining the efficacy of an intolerance of uncertainty focused psychoeducation intervention. 14.
Boswell JF, Thompson-Hollands J, Farchione TJ, Barlow DH. Intolerance of uncertainty: a common factor in the treatment of emotional disorders. J Clin Psychol. 2013 Jun;69(6):630-45. doi: 10.1002/jclp.21965. Epub 2013 Feb 4.
PubMed 23381685Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.
PubMed 16647833Dugas MJ, Schwartz A, Francis K. Brief Report: Intolerance of Uncertainty, Worry, and Depression. Cognit Ther Res. 2004;28(6):835-842. doi:10.1007/s10608-004-0669-0
Tolin DF, Abramowitz JS, Brigidi BD, Foa EB. Intolerance of uncertainty in obsessive-compulsive disorder. J Anxiety Disord. 2003;17(2):233-42. doi: 10.1016/s0887-6185(02)00182-2.
PubMed 12614665McEvoy PM, Hyett MP, Shihata S, Price JE, Strachan L. The impact of methodological and measurement factors on transdiagnostic associations with intolerance of uncertainty: A meta-analysis. Clin Psychol Rev. 2019 Nov;73:101778. doi: 10.1016/j.cpr.2019.101778. Epub 2019 Oct 31.
PubMed 31678816Raines AM, Oglesby ME, Walton JL, True G, Franklin CL. Intolerance of uncertainty and DSM-5 PTSD symptoms: Associations among a treatment seeking veteran sample. J Anxiety Disord. 2019 Mar;62:61-67. doi: 10.1016/j.janxdis.2018.12.002. Epub 2018 Dec 12.
PubMed 30572246Zerach G, Levi-Belz Y. Intolerance of Uncertainty Moderates the Association Between Potentially Morally Injurious Events and Suicide Ideation and Behavior Among Combat Veterans. J Trauma Stress. 2019 Jun;32(3):424-436. doi: 10.1002/jts.22366. Epub 2019 Feb 5.
PubMed 30720890Carleton RN. Fear of the unknown: One fear to rule them all? J Anxiety Disord. 2016 Jun;41:5-21. doi: 10.1016/j.janxdis.2016.03.011. Epub 2016 Mar 29.
PubMed 27067453Garami J, Haber P, Myers CE, Allen MT, Misiak B, Frydecka D, Moustafa AA. Intolerance of uncertainty in opioid dependency - Relationship with trait anxiety and impulsivity. PLoS One. 2017 Jul 31;12(7):e0181955. doi: 10.1371/journal.pone.0181955. eCollection 2017.
PubMed 28759635Grassi A, Gaggioli A, Behavior GR-C&, 2009 undefined. The green valley: the use of mobile narratives for reducing stress in commuters. liebertpub.com. https://www.liebertpub.com/doi/abs/10.1089/cpb.2008.0156?casa_token=byLouW-52ZcAAAAA:R7eHFRaJmuBay29q9Rzkhazn9jKeKZEpN_PDzWjAeM7GQRTWaSrV3M_EWPOhzsOO8S223f4JYmY. Accessed May 1, 2020.
Kenardy JA, Dow MG, Johnston DW, Newman MG, Thomson A, Taylor CB. A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial. J Consult Clin Psychol. 2003 Dec;71(6):1068-75. doi: 10.1037/0022-006X.71.6.1068.
PubMed 14622082Newman MG, Przeworski A, Consoli AJ, Taylor CB. A randomized controlled trial of ecological momentary intervention plus brief group therapy for generalized anxiety disorder. Psychotherapy (Chic). 2014 Jun;51(2):198-206. doi: 10.1037/a0032519. Epub 2013 Sep 23.
PubMed 24059730
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability/Feasibility Testing of an Intervention Targeting Intolerance of Uncertainty
- ClinicalTrials.gov ID
- NCT05172427
- Acronym / sponsor ID
- CLUE / BARLOW_CLUE intervention
- Conditions
- Generalized Anxiety Disorder, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Dec 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.
Anxiety disorders are prominent mental health burdens, affecting roughly 1 in 5 adults annually, and a third of individuals over the course of their life. These disorders are also impairing to individuals, with 23% of individuals with anxiety disorders describing their impairment as serious. Given the public health impact, it is crucial that interventions are designed to alleviate symptoms of anxiety, through reducing risk factors that predispose individuals to develop anxiety. One approach to do this is to develop brief interventions that could be administered virtually, which can then be supplemented using ecological momentary intervention (EMI) to reduce risk factors for anxiety disorders. In contrast to targeting more distant risk factors, targeting more direct risk factors, such as intolerance of uncertainty, could be used in the prevention and treatment of anxiety disorders.
Detailed description
Anxiety disorders have been estimated to impact roughly 1 in 5 (19%) adults in the United States over the past year, and almost a third (31%) of adults in the United States over the course of their life. Further, these disorders are impairing to individuals; 23% of individuals with anxiety disorders describing their impairment as serious. Given this public health impact, it is crucial, that interventions are designed to alleviate symptoms of anxiety, or to reduce risk factors that may predispose individuals to develop anxiety. Further, it is expected that the COVID-19 will have long-lasting impacts on mental concerns worldwide. With these concerns come new opportunities to improve mental health care, through ultra-brief, self-paced, web-based interventions. These interventions are ideal to increase access to care given their high dissemination value and low cost. Building on prior experimental and intervention work conducted by Dr. Allan, we aim to conduct pilot testing of an ultra-brief, CBT-informed intervention targeting intolerance of uncertainty, or an extreme aversion to and fear of uncertainty.
Intolerance of uncertainty is an ideal construct to target in a broad web-based intervention given theoretical and empirical links between intolerance of uncertainty and a broad spectrum of anxiety and related disorders. Theoretically, intolerance of uncertainty amplifies the experience of stress and anxiety causing people to engage in maladaptive cognitive (e.g., worry) and behavioral (e.g., checking, avoidance) strategies to reduce distress, preventing an opportunity to habituate to the uncertainty. Empirically, a recent meta-analysis reported effect sizes (ds) ranging from .4 to .6 across generalized anxiety disorder, major depression, obsessive compulsive disorder, social anxiety disorder, panic disorder and agoraphobia, and eating disorders. Other studies have implicated intolerance of uncertainty in posttraumatic stress disorder as well as suicidal thought and behavior. More recent evidence has demonstrated that intolerance of uncertainty is not only a "fundamental fear" underlying anxiety disorder etiology but has also been implicated in a host of other mental health problems, including substance use. We recently examined the impact of intolerance of uncertainty on anxiety and depression during the COVID-19 pandemic over three months and found intolerance of uncertainty was concurrently associated with and significantly predictive of symptoms of generalized anxiety disorder and depression. Therefore, not only is there strong theoretical and empirical support for intolerance of uncertainty as a transdiagnostic risk factor for anxiety and related conditions, but there is also evidence that supports intolerance of uncertainty as particularly relevant to the current environmental conditions due to COVID-19.
To date, we have conducted the only pilot RCT of a CBT-based intervention (clinicaltrials.gov NCT04199884). In a sample of 84 participants with elevated intolerance of uncertainty during their screening appointment, we compared a researcher-facilitated Intolerance of Uncertainty Treatment (IUT) to a time-matched healthy living control condition. IUT contains psychoeducation, challenging negative automatic thoughts regarding uncertainty through "mythbusting" exercises, and designing behavioral experiments to challenge these negative automatic thoughts. In this study, significant, medium effect size differences (d = .46) emerged between IUT and the control condition, but not until the month 1 follow-up. In addition, reductions in intolerance of uncertainty served as indirect effects from treatment condition to anxiety and depression symptoms. Further, most people found the intervention easy to understand, helpful, and applicable to their daily lives. Building on this prior work, we plan to adapt the existing ultra-brief intolerance of uncertainty intervention to be disseminated via a web-based computerized platform. Given the flexibility afforded via this digital platform, we also propose to include ecological momentary intervention (EMI) to enhance learning through the application of critical interventions skills as needed. EMI is ideal for these brief interventions as it allows for participants to gain the much-needed practice of challenging negative automatic thoughts and completing behavioral experiments critical to internalizing the skills and strategies taught during the intervention. Similar augmentations to brief interventions for stress, generalized anxiety disorder, and panic disorder (d = .5) have been successful in enhancing intervention effects (i.e., an additional d of .4 to .6), further underscoring the promise of including EMI to optimize outcomes.
The goals specific to this project are to 1) engage stakeholders in the design of an ultra-brief intolerance of uncertainty intervention (Enhanced Intolerance of Uncertainty Treatment [E-IUT]) and 2) to conduct a pilot trial to evaluate the acceptability, feasibility, and preliminary effect size estimates of E-IUT, in support of a larger fully powered test of E-IUT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of two active conditions or a waitlist control condition. Participants assigned to the EMA/EMI condition will receive the intervention, following by two weeks of EMA with personalized EMI prompts sent to them based on their responses to the EMA questions. Participants assigned to the EMA condition will receive the intervention, followed by two weeks of EMA only (with no EMI prompts based on their responses). The waitlist control will not receive the intervention prior to completing two weeks of EMA, and will not receive EMI prompts based on their responses. Those in the waitlist control will be given the opportunity to receive the intervention at their one-month follow up appointment.
| Arm | Type | Receives |
|---|---|---|
| CLUE intervention (EMA + EMI) | Active comparator | Behavioral: 14 days of EMI, Behavioral: Uncertainty reappraisal trainingParticipants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA, which will include EMI prompts that they come up with at the end of the CLUE intervention (framed as "key takeaways"). After the two week period of EMA/EMI, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention. |
| CLUE intervention (EMA only) | Active comparator | Behavioral: Uncertainty reappraisal trainingParticipants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention. |
| Waitlist control | No intervention | –Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, participants will be assigned 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline. One month after the post-intervention questionnaires, participants will complete a one-month follow up questionnaire battery, that will include parallel questions from baseline and post-intervention. As these participants did not receive the intervention following their baseline EMA, they will be given the opportunity to schedule an appointment for the intervention after they have completed their one-month follow up questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elevated GAD symptoms (i.e., GAD-7 scores greater than or equal to 10)
- Elevated IU symptoms (i.e., IUS-12 scores greater than or equal to 28)
- Access to a device with internet connection
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| 14 days of EMIFollowing the intervention, participants will receive personalized prompts whenever they report elevated stress or anxiety. These prompts will be generated at the end of the intervention session, and will only be sent to individuals in the EMI condition. | Behavioural | CLUE intervention (EMA + EMI) |
| Uncertainty reappraisal trainingCLUE consists of an hour long intervention, followed by a 2-week long EMI. During the hour long intervention session, participants will receive psychoeducation (i.e., defining uncertainty), discuss myths associated with uncertainty (e.g., if I do not plan things, they will go poorly), and discuss behavioral experiments that can be done to challenge uncertainty beliefs. | Behavioural | CLUE intervention (EMA + EMI), CLUE intervention (EMA only) |
Primary outcome
Client Satisfaction Questionnaire-8
Time frame: One day after 14-day EMA/EMI
The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale
Client Satisfaction Questionnaire-8
Time frame: One month follow up
The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale
Feasibility of service
Time frame: 14-day EMA/EMI
Feasibility will also be determined based on response rates for EMA/EMI. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery
53 secondary outcomes
Intolerance of Uncertainty-12
Time frame: Baseline
Intolerance of Uncertainty-12
Time frame: One day after 14-day EMA/EMI
Intolerance of Uncertainty-12
Time frame: One month follow up
PROMIS anxiety scale
Time frame: Baseline
PROMIS anxiety scale
Time frame: One day after 14-day EMA/EMI
PROMIS anxiety scale
Time frame: One month follow up
PROMIS depression scale
Time frame: Baseline
PROMIS depression scale
Time frame: One day after 14-day EMA/EMI
PROMIS depression scale
Time frame: One month follow up
PROMIS stress scale
Time frame: Baseline
PROMIS stress scale
Time frame: One day after 14-day EMA/EMI
PROMIS stress scale
Time frame: One month follow up
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: One day after 14-day EMA/EMI
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: One month follow up
Drug Use Disorders Identification Test (DUDIT)
Time frame: Baseline
Drug Use Disorders Identification Test (DUDIT)
Time frame: One day after 14-day EMA/EMI
Drug Use Disorders Identification Test (DUDIT)
Time frame: One month follow up
COVID-19 impact battery short-form (CIB-SF)
Time frame: Baseline
COVID-19 impact battery short-form (CIB-SF)
Time frame: One day after 14-day EMA/EMI
COVID-19 impact battery short-form (CIB-SF)
Time frame: One month follow up
COVID-19 contraction questions
Time frame: Baseline
COVID-19 contraction questions
Time frame: One day after 14-day EMA/EMI
COVID-19 contraction questions
Time frame: One month follow up
Insomnia Severity Index (ISI)
Time frame: Baseline
Insomnia Severity Index (ISI)
Time frame: One day after 14-day EMA/EMI
Insomnia Severity Index (ISI)
Time frame: One month follow up
Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline
Penn State Worry Questionnaire (PSWQ)
Time frame: One day after 14-day EMA/EMI
Penn State Worry Questionnaire (PSWQ)
Time frame: One month follow up
The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time frame: Baseline
The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time frame: One day after 14-day EMA/EMI
The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time frame: One month follow up
Perseverative Thought Questionnaire (PTQ)
Time frame: Baseline
Perseverative Thought Questionnaire (PTQ)
Time frame: One day after 14-day EMA/EMI
Perseverative Thought Questionnaire (PTQ)
Time frame: One month follow up
Ruminative Response Scale (RRS)
Time frame: Baseline
Ruminative Response Scale (RRS)
Time frame: One day after 14-day EMA/EMI
Ruminative Response Scale (RRS)
Time frame: One month follow up
Positive and Negative Affect Schedule-SF
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- BackgroundHarvard Medical School, 2007. National Comorbidity Survey (NCS). (2017, August 21). Retrieved from https://www.hcp.med.harvard.edu/ncs/index.php. Data Table 2: 12-month prevalence DSM-IV/WMH-CIDI disorders by sex and cohort.
- Background: PubMed 28531873Oglesby 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.
- BackgroundShapiro, M. O., Allan, N. P., & Schmidt, N. B. (under review). A randomized control trial examining the efficacy of an intolerance of uncertainty focused psychoeducation intervention. 14.
- Background: PubMed 23381685Boswell JF, Thompson-Hollands J, Farchione TJ, Barlow DH. Intolerance of uncertainty: a common factor in the treatment of emotional disorders. J Clin Psychol. 2013 Jun;69(6):630-45. doi: 10.1002/jclp.21965. Epub 2013 Feb 4.
- Background: PubMed 16647833Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.
- BackgroundDugas MJ, Schwartz A, Francis K. Brief Report: Intolerance of Uncertainty, Worry, and Depression. Cognit Ther Res. 2004;28(6):835-842. doi:10.1007/s10608-004-0669-0
- Background: PubMed 12614665Tolin DF, Abramowitz JS, Brigidi BD, Foa EB. Intolerance of uncertainty in obsessive-compulsive disorder. J Anxiety Disord. 2003;17(2):233-42. doi: 10.1016/s0887-6185(02)00182-2.
- Background: PubMed 31678816McEvoy PM, Hyett MP, Shihata S, Price JE, Strachan L. The impact of methodological and measurement factors on transdiagnostic associations with intolerance of uncertainty: A meta-analysis. Clin Psychol Rev. 2019 Nov;73:101778. doi: 10.1016/j.cpr.2019.101778. Epub 2019 Oct 31.
- Background: PubMed 30572246Raines AM, Oglesby ME, Walton JL, True G, Franklin CL. Intolerance of uncertainty and DSM-5 PTSD symptoms: Associations among a treatment seeking veteran sample. J Anxiety Disord. 2019 Mar;62:61-67. doi: 10.1016/j.janxdis.2018.12.002. Epub 2018 Dec 12.
- Background: PubMed 30720890Zerach G, Levi-Belz Y. Intolerance of Uncertainty Moderates the Association Between Potentially Morally Injurious Events and Suicide Ideation and Behavior Among Combat Veterans. J Trauma Stress. 2019 Jun;32(3):424-436. doi: 10.1002/jts.22366. Epub 2019 Feb 5.
- Background: PubMed 27067453Carleton RN. Fear of the unknown: One fear to rule them all? J Anxiety Disord. 2016 Jun;41:5-21. doi: 10.1016/j.janxdis.2016.03.011. Epub 2016 Mar 29.
- Background: PubMed 28759635Garami J, Haber P, Myers CE, Allen MT, Misiak B, Frydecka D, Moustafa AA. Intolerance of uncertainty in opioid dependency - Relationship with trait anxiety and impulsivity. PLoS One. 2017 Jul 31;12(7):e0181955. doi: 10.1371/journal.pone.0181955. eCollection 2017.
- 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 14 days of EMI and Uncertainty reappraisal training in people with Generalized Anxiety Disorder 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 3 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 29 Dec 2021. 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?
Client Satisfaction Questionnaire-8 (time frame: One day after 14-day EMA/EMI). The study lists 3 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 NCT05172427, which also lists 15 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 29 Dec 2021.