LonelinessNCT04064372
Mindful Response to Adversity: A Brief Stress Resilience Training
A study testing Mindful response to adversity brief training and Strengths-based response to adversity brief training in people with Loneliness and Depression, run by Carnegie Mellon University at 1 site in United States.
Trial summary
The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Depression
- What is being tested?
- Mindful response to adversity brief training and Strengths-based response to adversity brief training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 13 Dec 2019
- 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
- Full-time first-year student at Carnegie Mellon University.
- Adult (age 18+)
- Must own a data-enabled smartphone
- Scores indicating moderate to high levels of depressive symptomatology (composite score > or equal to 2 on the short-form (6-item) Beck Depression Inventory).
Who cannot join
- Potential participants who score a 0 or a 1 on the 6-item BDI section will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Mindful Response to Adversity: A Brief Stress Resilience Training for Improving Mental Health in Students
The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
Read the detailed description
The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. The investigators will also work closely with institutional officials to assess whether the intervention can improve student well-being. Specifically, the project aims to teach freshman students (who are at high risk for depression) skills in how to foster a mindful response to adversity at the beginning of the school term, along with periodic support reminders (via text message) during high stress/vulnerability periods over the course of the semester. The investigators will adopt a randomized controlled trial approach to rigorously evaluate whether this intervention can be adopted as a standard onboarding program for all incoming freshman students during the first weeks of orientation on the CMU campus. Participants will come for the study session and provide a dried blood spot sample and complete a battery of self-report questionnaires.
Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G). Salivary cortisol measures will be collected throughout the TSST-G.
The treatment condition will be trained in techniques designed to teach a "mindful approach to adversity". These techniques will include: normalizing, attention, equanimity, non-judgment, de-centering, accepting of experiences, and impermanence. Participants will be instructed on the mindset, asked to write about an instance of non-judgment and share with a partner, and then guided through a short training designed to practice each skill.
The control condition will be trained in techniques designed to teach a typical narrative self-analysis / strengths-based approach to adversity. These techniques will include: choosing the best approach, minimizing stress, and identifying and enhancing personal strengths. Participants will be instructed on the mindset, asked to write about an instance of personal strength and share with a partner, and then guided through a short training designed to practice each skill.
Daily diary measures will be collected for 7 days following the study session and 1 week before the follow-up session. Microhit boosters will be sent to participants at self-identified high stress periods, which remind participants of the training session skills.
Participants will come for the follow-up session and provide a dried blood spot sample and complete a battery of self-report questionnaires.
- Conditions
- Loneliness, Depression
- Being tested
- Mindful response to adversity brief training, Strengths-based response to adversity brief training
- Keywords
- Mindfulness, Resilience, Equanimity, Inflammation, Wise Intervention
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful response to adversity brief trainingBehavioural
Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of mindfulness, equanimity, and non-judgment, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
Strengths-based response to adversity brief trainingBehavioural
Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of strengths-based, narrative self-analysis, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
| Study group | Role | What they receive |
|---|---|---|
| Mindful Response to Adversity | Experimental | The treatment condition will be trained in techniques designed to teach a "mindful approach to adversity". These techniques will include: normalizing, attention, equanimity, non-judgment, de-centering, accepting of experiences, and impermanence. Participants will be instructed on the mindset, asked to write about an instance of non-judgment and share with a partner, and then guided through a short training designed to practice each skill. Receives: Behavioral: Mindful response to adversity brief training |
| Strength-based approach to adversity | Active comparator | The control condition will be trained in techniques designed to teach a typical narrative self-analysis / strengths-based approach to adversity. These techniques will include: choosing the best approach, minimizing stress, and identifying and enhancing personal strengths. Participants will be instructed on the mindset, asked to write about an instance of personal strength and share with a partner, and then guided through a short training designed to practice each skill. Receives: Behavioral: Strengths-based response to adversity brief training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Depression
In a daily diary, participants are asked at the end of the day to identify the extent to which they endorse symptoms measuring depressive symptomatology (i.e. "feeling hopeless about the future", "feeling blue") for that day.
Analyses will use multilevel modeling to test for a time by condition interaction showing lower daily depressive symptomatology at post-treatment in the equanimity compared to the strength based group.
Measured: Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.
Depression I
Evaluated using the validated 21-item Beck Depression Inventory (BDI), which is designed to measure characteristic attitudes and symptoms of depression. The score for each item ranges between 0-3, where 0 denotes less depression (e.g. "I do not feel sad") and 3 denotes more depression (e.g. "I am so dan and unhappy that I can't stand it"). Total score will be between 0-63, where 0 indicates no depression and 63 indicates extreme depression. The score is a total of 21 questions and the following is a typical subscale range distribution:
1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.
Measured: Change in depression over 4-month period.
Depression II
Evaluated using the validated 20-item Center for Epidemiologic Studies Depression scale (CES-D), which is designed to measure characteristic attitudes and symptoms of depression. There are 20 questions and the score for each item ranges between 0-3. For most questions, a lower score indicates lack of depression and a higher score indicates high depression (e.g. in response to the statement "I felt fearful" a 0 indicates rarely and 3 indicates most or all of the time). Questions 4, 8, 12, and 16 are reverse scored. The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.
Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.
Measured: Change in depression over 4-month period.
Daily Social Connection
Following Hawkley et al. (2007) and our previous studies, end-of-day daily diary questions will assess the amount of time spent interacting with others and the extent to which social interactions throughout the day were perceived as positive. Example items: "How much time did you spend today with others, talking or listening to them?" (0 = little or none of the day to 4 = most or all of the day) and "How many positive interactions did you have today (e.g., supportive, enjoyable, rewarding, affirming)?" (0 = one, 1 = several, 2 = many).
Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social connection at post-treatment in the equanimity compared to the strength based group.
Measured: Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.
Daily Belonging
End-of-day daily diary questions will measure feelings of belonging and closeness at school. Example items: "I felt like I belong in school" and "I felt like no one really knew me well at school (reverse-scored)" (0= Not at all, 4= Extremely).
Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social belonging at post-treatment in the equanimity compared to the strength based group.
Measured: Change in loneliness over 4-month period.
Loneliness
Evaluated using the University of California, Los Angeles (UCLA) Loneliness Scale. The University of California, Los Angeles (UCLA) Loneliness scale is designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either A ("I always feels this way"), O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Scores are summed from each item and higher scores indicate greater degrees of loneliness. Scores of 15-20 indicate average level of loneliness; 21-30 indicate frequent loneliness; 31-40 indicate severe loneliness.
Analyses will use multilevel modeling to test for a time by condition interaction showing decreased loneliness at post-treatment in the equanimity compared to the strength based group.
Measured: Change in loneliness over 4-month period.
Secondary outcomes (12)
Academic performance
Academic performance will be assessed using Grade Point Average (GPA). Analyses will use multilevel modeling to test for a time by condition interaction higher GPA at post treatment (and follow-up) in the equanimity compared to the strength based group.
Measured: Change in GPA between semester immediately prior to enrollment and semester during enrollment in the study (approximately 5 months).
Occurrences of Daily Acceptance
End-of-day perceptions of daily acceptance (used in Chin et al., under review) will be measured (Example questions" Today, I was able to accept myself as I am", "Today, I've been judging the situation that I am in or the events that are occurring as good or bad").
Analyses will use multilevel modeling to test for a time by condition interaction showing increased acceptance and non-judgment at post-treatment in the equanimity compared to the strength based group.
Measured: Assessed daily for seven days during week 2 and week 16 of the study.
Physical Activity (FitBit)
Activity data for number of steps will be assessed using a FitBit device worn by participants.
Multi-level models will test for time by treatment interactions showing increased physical activity outcomes over time in the equanimity compared to the strength based group.
Measured: Assessed daily during week 2-17 of the study.
Sleep (FitBit)
Activity data for sleep will be assessed using a FitBit device worn by participants.
Multi-level models will test for time by treatment interactions showing increased sleep outcomes over time in the equanimity compared to the strength based group.
Measured: Assessed daily during week 2-17 of the study.
Concentrations of pro-inflammatory gene expression
Gene expression measures of immune system function will be collected via dried blood spot collection method.
Multi-level models will test for time by condition effects. Analyses will focus an a priori-specified gene regulation pattern involving increased expression of inflammation-related genes and decreased expression of antiviral gene - a pattern called the conserved transcriptional response to adversity (CTRA; Cole, 2012).
Measured: Change in gene expression over weeks 1 and weeks 17 of the study.
Concentrations of C-Reactive Protein
CRP will be assessed through dried blood spots collected at baseline and post-intervention.
Changes in CRP will be assessed using a time by group interaction.
Measured: Change in CRP over 4-month period.
Concentrations of salivary cortisol
Saliva samples will be collected before and after the TSST, and assayed for salivary cortisol determination.
Salivary cortisol will be analyzed both using area-under-the-curve (AUC) and mixed effects linear models, testing for a time by condition interaction showing that equanimity group has reduced cortisol reactivity to the TSST over time relative to the strength based group.
Measured: Four cortisol samples will be collected at the baseline session. One sample before and three samples after the acute stress challenge using the TSST.
Perceived Stress
Evaluated using Perceived Stress Scale (PSS). The PSS measures the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Analyses will use multilevel modeling to test for a time by condition interaction showing decreased reported stress at post-treatment in the equanimity compared to the strength based group.
Measured: Change in perceived stress over 4-month period.
Subjective Social Status
Created by health psychologist Nancy Adler and team (2000), the MacArthur Scale of Subjective Social Status is a single-item measure that assesses a person's perceived rank relative to others in their group. Respondents view a drawing of a ladder with 10 rungs, and either read that the ladder represents where people stand in society. Respondents further read : "At the top of the ladder are the people who are the best off, those who have the most money, most education, and best jobs. At the bottom are the people who are the worst off, those who have the least money, least education, worst jobs, or no job. Please place an 'X' on the rung that best represents where you think you stand on the ladder.". Rungs are translated to numbers (1-10). Choosing higher rungs of the ladder (e.g. 10) indicates perception of higher social status and choosing lower rungs of the ladder (e.g. 1) indicates lower social status.
Measured: Measured at baseline only.
Daily Resilience using the Brief Resilience Scale
End-of-day items will measure resilience over the course of the day. The Brief Resilience Scale (BRS, Smith et al. 2008) is a 6-item survey that assesses the ability to bounce back or recover from stress (e.g. "It does not take me long to recover from a stressful event."). Some items are reverse scored and then all items are summed. Higher scores reflect more resilience. Analyses will use multilevel modeling to test for a time by condition interaction showing increased resilience in daily life at post-treatment in the equanimity compared to the strength based group.
Measured: Assessed daily for seven days during week 2 and week 16 of the study.
Daily Occurrence of Stress and Successful Coping Scale
End-of-day items will measure the perception of stress occurrence and types (e.g. "concerns about academic performance" or "family concerns") and overall perceptions of coping ability scale (e.g. Since the last survey, to what extent do you feel like your demands exceeded your ability to cope with them?") over the course of the day. Scale ranges from 0="not at all true" to 4 = "extremely true"), where higher scores indicate less successful coping (item 3 reverse scored).
Analyses will use multilevel modeling to test for a time by condition interaction showing decreased stress (and increased coping) in daily life at post-treatment in the equanimity compared to the strength based group.
Measured: Assessed daily for seven days during week 2 and week 16 of the study.
Daily State Mindfulness Scale
End-of-day items will measure state mindfulness over the course of the day (e.g. "I was thinking about something other than what I was currently doing" is reverse scored). The scale ranges from 0=Strongly agree to 5= Strongly disagree. Higher scores indicate higher state mindfulness.
Analyses will use multilevel modeling to test for a time by condition interaction showing increased mindfulness in daily life at post-treatment in the equanimity compared to the strength based group.
Measured: Assessed daily for seven days during week 2 and week 16 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start26 Aug 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064372
- Sponsor's protocol ID
- 182R07SM
- Status last verified
- Feb 2020
- First submitted
- 1 Jan 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
PubMed 32691879
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Response to Adversity: A Brief Stress Resilience Training for Improving Mental Health in Students
- ClinicalTrials.gov ID
- NCT04064372
- Acronym / sponsor ID
- 182R07SM
- Conditions
- Loneliness, Depression
- Keywords
- Mindfulness, Resilience, Equanimity, Inflammation, Wise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 21 Aug 2019 (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 investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
Detailed description
The investigators will conduct an intervention study with the aim of improving stress resilience and mental health outcomes in at-risk freshman students. The investigators will also work closely with institutional officials to assess whether the intervention can improve student well-being. Specifically, the project aims to teach freshman students (who are at high risk for depression) skills in how to foster a mindful response to adversity at the beginning of the school term, along with periodic support reminders (via text message) during high stress/vulnerability periods over the course of the semester. The investigators will adopt a randomized controlled trial approach to rigorously evaluate whether this intervention can be adopted as a standard onboarding program for all incoming freshman students during the first weeks of orientation on the CMU campus. Participants will come for the study session and provide a dried blood spot sample and complete a battery of self-report questionnaires.
Participants will attend a group training session, led by a professional instructor, about responding to adversity, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that the participants just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G). Salivary cortisol measures will be collected throughout the TSST-G.
The treatment condition will be trained in techniques designed to teach a "mindful approach to adversity". These techniques will include: normalizing, attention, equanimity, non-judgment, de-centering, accepting of experiences, and impermanence. Participants will be instructed on the mindset, asked to write about an instance of non-judgment and share with a partner, and then guided through a short training designed to practice each skill.
The control condition will be trained in techniques designed to teach a typical narrative self-analysis / strengths-based approach to adversity. These techniques will include: choosing the best approach, minimizing stress, and identifying and enhancing personal strengths. Participants will be instructed on the mindset, asked to write about an instance of personal strength and share with a partner, and then guided through a short training designed to practice each skill.
Daily diary measures will be collected for 7 days following the study session and 1 week before the follow-up session. Microhit boosters will be sent to participants at self-identified high stress periods, which remind participants of the training session skills.
Participants will come for the follow-up session and provide a dried blood spot sample and complete a battery of self-report questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Response to Adversity | Experimental | Behavioral: Mindful response to adversity brief trainingThe treatment condition will be trained in techniques designed to teach a "mindful approach to adversity". These techniques will include: normalizing, attention, equanimity, non-judgment, de-centering, accepting of experiences, and impermanence. Participants will be instructed on the mindset, asked to write about an instance of non-judgment and share with a partner, and then guided through a short training designed to practice each skill. |
| Strength-based approach to adversity | Active comparator | Behavioral: Strengths-based response to adversity brief trainingThe control condition will be trained in techniques designed to teach a typical narrative self-analysis / strengths-based approach to adversity. These techniques will include: choosing the best approach, minimizing stress, and identifying and enhancing personal strengths. Participants will be instructed on the mindset, asked to write about an instance of personal strength and share with a partner, and then guided through a short training designed to practice each skill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Full-time first-year student at Carnegie Mellon University.
- Adult (age 18+)
- Must own a data-enabled smartphone
- Scores indicating moderate to high levels of depressive symptomatology (composite score > or equal to 2 on the short-form (6-item) Beck Depression Inventory).
Key exclusion criteria (1 listed)
- Potential participants who score a 0 or a 1 on the 6-item BDI section will not be eligible.
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 |
|---|---|---|
| Mindful response to adversity brief trainingParticipants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of mindfulness, equanimity, and non-judgment, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G). | Behavioural | Mindful Response to Adversity |
| Strengths-based response to adversity brief trainingParticipants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of strengths-based, narrative self-analysis, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G). | Behavioural | Strength-based approach to adversity |
Primary outcome
Daily Depression
Time frame: Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.
In a daily diary, participants are asked at the end of the day to identify the extent to which they endorse symptoms measuring depressive symptomatology (i.e. "feeling hopeless about the future", "feeling blue") for that day. Analyses will use multilevel modeling to test for a time by condition interaction showing lower daily depressive symptomatology at post-treatment in the equanimity compared to the strength based group.
Depression I
Time frame: Change in depression over 4-month period.
Evaluated using the validated 21-item Beck Depression Inventory (BDI), which is designed to measure characteristic attitudes and symptoms of depression. The score for each item ranges between 0-3, where 0 denotes less depression (e.g. "I do not feel sad") and 3 denotes more depression (e.g. "I am so dan and unhappy that I can't stand it"). Total score will be between 0-63, where 0 indicates no depression and 63 indicates extreme depression. The score is a total of 21 questions and the following is a typical subscale range distribution: 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.
Depression II
Time frame: Change in depression over 4-month period.
Evaluated using the validated 20-item Center for Epidemiologic Studies Depression scale (CES-D), which is designed to measure characteristic attitudes and symptoms of depression. There are 20 questions and the score for each item ranges between 0-3. For most questions, a lower score indicates lack of depression and a higher score indicates high depression (e.g. in response to the statement "I felt fearful" a 0 indicates rarely and 3 indicates most or all of the time). Questions 4, 8, 12, and 16 are reverse scored. The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed. Analyses will use multilevel modeling to test for a time by condition interaction showing lower depressive symptomatology at post-treatment in the equanimity compared to the strength based treatment group.
Daily Social Connection
Time frame: Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.
Following Hawkley et al. (2007) and our previous studies, end-of-day daily diary questions will assess the amount of time spent interacting with others and the extent to which social interactions throughout the day were perceived as positive. Example items: "How much time did you spend today with others, talking or listening to them?" (0 = little or none of the day to 4 = most or all of the day) and "How many positive interactions did you have today (e.g., supportive, enjoyable, rewarding, affirming)?" (0 = one, 1 = several, 2 = many). Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social connection at post-treatment in the equanimity compared to the strength based group.
Daily Belonging
Time frame: Change in loneliness over 4-month period.
End-of-day daily diary questions will measure feelings of belonging and closeness at school. Example items: "I felt like I belong in school" and "I felt like no one really knew me well at school (reverse-scored)" (0= Not at all, 4= Extremely). Analyses will use multilevel modeling to test for a time by condition interaction showing increased daily social belonging at post-treatment in the equanimity compared to the strength based group.
Loneliness
Time frame: Change in loneliness over 4-month period.
Evaluated using the University of California, Los Angeles (UCLA) Loneliness Scale. The University of California, Los Angeles (UCLA) Loneliness scale is designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either A ("I always feels this way"), O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Scores are summed from each item and higher scores indicate greater degrees of loneliness. Scores of 15-20 indicate average level of loneliness; 21-30 indicate frequent loneliness; 31-40 indicate severe loneliness. Analyses will use multilevel modeling to test for a time by condition interaction showing decreased loneliness at post-treatment in the equanimity compared to the strength based group.
12 secondary outcomes
Academic performance
Time frame: Change in GPA between semester immediately prior to enrollment and semester during enrollment in the study (approximately 5 months).
Occurrences of Daily Acceptance
Time frame: Assessed daily for seven days during week 2 and week 16 of the study.
Physical Activity (FitBit)
Time frame: Assessed daily during week 2-17 of the study.
Sleep (FitBit)
Time frame: Assessed daily during week 2-17 of the study.
Concentrations of pro-inflammatory gene expression
Time frame: Change in gene expression over weeks 1 and weeks 17 of the study.
Concentrations of C-Reactive Protein
Time frame: Change in CRP over 4-month period.
Concentrations of salivary cortisol
Time frame: Four cortisol samples will be collected at the baseline session. One sample before and three samples after the acute stress challenge using the TSST.
Perceived Stress
Time frame: Change in perceived stress over 4-month period.
Subjective Social Status
Time frame: Measured at baseline only.
Daily Resilience using the Brief Resilience Scale
Time frame: Assessed daily for seven days during week 2 and week 16 of the study.
Daily Occurrence of Stress and Successful Coping Scale
Time frame: Assessed daily for seven days during week 2 and week 16 of the study.
Daily State Mindfulness Scale
Time frame: Assessed daily for seven days during week 2 and week 16 of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 32691879Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful response to adversity brief training and Strengths-based response to adversity brief training in people with Loneliness and Depression, run by Carnegie Mellon 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: finished, as of the sponsor's last update on 3 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Depression (time frame: Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.). The study lists 6 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 NCT04064372, which also lists 1 linked publication.
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 3 Mar 2020.