A Phase 2 interventional study of Cognitive Bias Modification - Interpretation training and Coaching in Anxiety, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The project aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.
Approximately 25-30% of the U.S. population will experience anxiety pathology severe enough to qualify for an anxiety disorder diagnosis during their lifetime. Critically, the majority will not receive treatment, creating a serious need to consider alternative approaches to delivering mental health services that can meet needs on a larger scale. Cognitive Bias Modification (CBM) interventions for anxiety hold considerable promise as a way to meet these needs. These programs alter biased ways of thinking, such as selective assignment of threat interpretations, which are known to cause and maintain anxiety. CBM for interpretation bias (CBM-I) has established efficacy when administered via computer in the laboratory, and there is clear evidence for target engagement (i.e., change in interpretations, the identified mechanism). Now, effectiveness needs to be tested in the community, using sufficiently large samples to evaluate key moderators of its effects, including delivery method (computer vs. mobile phone) and the addition of minimal human contact (for those at risk of attrition). Addressing attrition is critical given high rates of drop out for web-based interventions. Via the PI's MindTrails web site (established with the lab's prior NIMH R34MH106770 award), the lab already has the infrastructure to deliver CBM to the public and recruit large anxious samples. Moreover, the PI and Co-I have established infrastructure to do mobile sensing of mood and CBM-I delivery via mobile phones. Thus, the project can respond to NIMH's request for "Effectiveness trials that can contribute to advancing the personalization of mental health care." The current proposal aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes. Study 1 will provide a pilot feasibility and user experience test of the CBM-I program on mobile phones. Study 2 will examine the lab's current online, computer-based CBM-I data to help determine empirical indicators of attrition. Study 3 will provide the primary test of moderators of effectiveness. Namely, in Study 3, high anxious participants will be randomized to one of 2 conditions: 1) CBM-I training delivered by computer or mobile phone (at existing MindTrails site); 2) Alternate intervention group-Psychoeducation only. CBM-I and Psychoeducation conditions include 5 weekly training sessions. Based on theoretically- and empirically-derived predictors of attrition, participants identified as high-risk for dropout in condition 1 will then be randomly assigned to add minimal human contact (using a modified TeleCoach protocol) or no change. Using this adaptive intervention, known as Sequential, Multiple Assignment, Randomized Trial (SMART), the project can test both the effects of CBM-I delivery method and the added value of human contact to improve retention for participants at high-risk for dropping out.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 1,748 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Virginia is the lead sponsor of 676 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Behavioral: Cognitive Bias Modification - Interpretation training
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Behavioral: Cognitive Bias Modification - Interpretation training · Behavioral: Coaching
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Behavioral: Cognitive Bias Modification - Interpretation training
Online psychoeducation about anxiety
Behavioral: Online psychoeducation about anxiety
Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
Change in Recognition Ratings (Positive Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Recognition Ratings (Negative Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Overall Anxiety Severity and Impairment Scale
This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
Time frame: Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session.
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Depression Comorbid Symptoms
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Alcohol Use Comorbid Symptoms
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Wellness Measures - Optimism
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Wellness Measures - Growth Mindset
Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Wellness Measures - Self-efficacy
Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Wellness Measures - Life Satisfaction
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life. Participants are asked "All things considered, how satisfied are you with your life as a whole?" and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility. Participants are asked "I often look at a situation from different viewpoints." with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance. Participants are asked "I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them." with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal. Participants are given two statements - "When I want to feel more positive emotion, I change the way I'm thinking about the situation" and "When I want to feel less negative emotion, I change the way I'm thinking about the situation" - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Change in Anxiety and Identity Circles
We will assess change in the extent anxiety is viewed as central to the person's self-concept. Participants are asked "To what extent is your anxiety a central part of who you are currently?" and provided with 5 images of two circles, one labeled "My Anxiety" and one labeled "Me", where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
| Milestone | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment |
|---|---|---|---|---|---|---|---|
| Started | 149 | 288 | 265 | 282 | 242 | 13 | 509 |
| Completed | 0 | 140 | 134 | 131 | 154 | 0 | 0 |
| Not completed | 149 | 148 | 131 | 151 | 88 | 13 | 509 |
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
| units on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 2.40 ± 0.47 | 2.29 ± 0.53 | 2.29 ± 0.54 | 2.30 ± 0.53 | 2.33 ± 0.54 | 2.40 ± 0.60 |
| Session 3 assessment | — | 2.89 ± 0.44 | 2.84 ± 0.48 | 2.92 ± 0.49 | 2.39 ± 0.57 | — |
| Session 5 assessment | — | 2.83 ± 0.52 | 2.92 ± 0.44 | 2.86 ± 0.50 | 2.42 ± 0.55 | — |
| Follow-up assessment | — | 2.71 ± 0.47 | 2.80 ± 0.46 | 2.75 ± 0.54 | 2.48 ± 0.53 | — |
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
| units on a scale | CBM-I, Not Classified as High/Low Risk for Attrition | CBM-I, Low Attrition | CBM-I, High Attrition, no Coach | CBM-I, High Attrition, Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 2.78 ± 0.53 | 2.90 ± 0.54 | 2.96 ± 0.51 | 2.94 ± 0.55 | 2.89 ± 0.50 | 2.70 ± 0.60 |
| Session 3 assessment | — | 2.56 ± 0.56 | 2.49 ± 0.55 | 2.46 ± 0.58 | 2.87 ± 0.55 | — |
| Session 5 assessment | — | 2.58 ± 0.55 | 2.53 ± 0.56 | 2.56 ± 0.52 | 2.74 ± 0.59 | — |
| Follow-up assessment | — | 2.55 ± 0.55 | 2.48 ± 0.56 | 2.43 ± 0.58 | 2.68 ± 0.58 | — |
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.
| units on a scale | CBM-I, Not Classified as High/Low Risk for Attrition | CBM-I, Low Attrition | CBM-I, High Attrition, no Coach | CBM-I, High Attrition, Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 2.04 ± 0.55 | 2.00 ± 0.53 | 2.13 ± 0.49 | 2.05 ± 0.52 | 2.07 ± 0.55 | 2.23 ± 0.38 |
| Session 3 assessment | — | 2.25 ± 0.55 | 2.38 ± 0.53 | 2.36 ± 0.52 | 2.20 ± 0.51 | — |
| Session 5 assessment | — | 2.34 ± 0.62 | 2.51 ± 0.52 | 2.45 ± 0.53 | 2.19 ± 0.58 | — |
| Follow-up assessment | — | 2.31 ± 0.56 | 2.35 ± 0.58 | 2.36 ± 0.55 | 2.23 ± 0.61 | — |
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.
| units on a scale | CBM-I, Not Classified as High/Low Risk for Attrition | CBM-I, Low Attrition | CBM-I, High Attrition, no Coach | CBM-I, High Attrition, Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 1.42 ± 0.83 | 1.61 ± 0.86 | 1.52 ± 0.81 | 1.58 ± 0.82 | 1.61 ± 0.81 | 1.35 ± 0.94 |
| Session 3 assessment | — | 0.93 ± 0.80 | 0.85 ± 0.66 | 0.85 ± 0.71 | 1.36 ± 0.81 | — |
| Session 5 assessment | — | 0.81 ± 0.68 | 0.77 ± 0.68 | 0.83 ± 0.70 | 1.24 ± 0.78 | — |
| Follow-up assessment | — | 0.78 ± 0.62 | 0.79 ± 0.62 | 0.69 ± 0.57 | 1.16 ± 0.77 | — |
This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
| units on a scale | CBM-I, Not Classified as High/Low Risk for Attrition | CBM-I, Low Attrition | CBM-I, High Attrition, no Coach | CBM-I, High Attrition, Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 2.28 ± 0.75 | 2.32 ± 0.71 | 2.31 ± 0.67 | 2.34 ± 0.67 | 2.31 ± 0.68 | 2.62 ± 0.79 |
| Session 1 assessment | 2.00 ± NA | 2.22 ± 0.73 | 2.15 ± 0.75 | 2.21 ± 0.72 | 2.24 ± 0.73 | — |
| Session 2 assessment | — | 1.75 ± 0.74 | 1.71 ± 0.74 | 1.79 ± 0.75 | 1.92 ± 0.75 | — |
| Session 3 assessment | — | 1.80 ± 0.80 | 1.72 ± 0.79 | 1.84 ± 0.74 | 2.00 ± 0.78 | — |
| Session 4 assessment | — | 1.63 ± 0.84 | 1.48 ± 0.80 | 1.53 ± 0.78 | 1.85 ± 0.90 | — |
| Session 5 assessment | — | 1.58 ± 0.78 | 1.50 ± 0.78 | 1.62 ± 0.80 | 1.77 ± 0.85 | — |
| Follow-up assessment | — | 1.59 ± 0.79 | 1.56 ± 0.87 | 1.60 ± 0.79 | 1.68 ± 0.81 | — |
This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.
| units on a scale | CBM-I, Not Classified as High/Low Risk for Attrition | CBM-I, Low Attrition | CBM-I, High Attrition, no Coach | CBM-I, High Attrition, Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline assessment | 1.61 ± 0.55 | 1.58 ± 0.53 | 1.65 ± 0.54 | 1.65 ± 0.53 | 1.65 ± 0.52 | 1.71 ± 0.64 |
| Session 3 assessment | — | 1.01 ± 0.61 | 0.98 ± 0.62 | 1.07 ± 0.62 | 1.19 ± 0.64 | — |
| Session 5 assessment | — | 0.89 ± 0.58 | 0.83 ± 0.57 | 0.89 ± 0.62 | 1.03 ± 0.67 | — |
| Follow-up assessment | — | 0.82 ± 0.57 | 0.80 ± 0.63 | 0.80 ± 0.64 | 0.97 ± 0.62 | — |
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 2.77 ± 0.86 | 2.76 ± 0.90 | 2.68 ± 0.93 | 2.77 ± 0.91 | 2.78 ± 0.89 | 2.92 ± 0.95 |
| Session 3 | — | 2.35 ± 0.92 | 2.22 ± 0.86 | 2.32 ± 0.90 | 2.49 ± 0.96 | — |
| Session 5 | — | 2.15 ± 0.92 | 2.12 ± 0.90 | 2.13 ± 0.90 | 2.36 ± 0.97 | — |
| 2-month Follow-up | — | 2.15 ± 0.91 | 2.00 ± 0.93 | 2.00 ± 0.89 | 2.09 ± 0.88 | — |
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 0.92 ± 0.82 | 0.90 ± 0.84 | 0.94 ± 0.86 | 0.95 ± 0.79 | 0.90 ± 0.89 | 0.64 ± 0.73 |
| Session 3 | — | 0.88 ± 0.89 | 0.92 ± 0.83 | 0.80 ± 0.73 | 0.84 ± 0.85 | — |
| Session 5 | — | 0.75 ± 0.75 | 0.85 ± 0.77 | 0.71 ± 0.73 | 0.78 ± 0.80 | — |
| 2-month Follow-up | — | 0.78 ± 0.80 | 0.80 ± 0.70 | 0.59 ± 0.62 | 0.71 ± 0.80 | — |
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 1.33 ± 1.00 | 1.40 ± 0.97 | 1.39 ± 0.96 | 1.45 ± 1.02 | 1.29 ± 0.97 | 1.85 ± 1.43 |
| Session 3 | — | 1.82 ± 0.94 | 1.82 ± 1.05 | 1.79 ± 1.07 | 1.52 ± 0.98 | — |
| Session 5 | — | 1.85 ± 1.03 | 1.97 ± 1.06 | 1.82 ± 1.01 | 1.57 ± 0.97 | — |
| 2-month Follow-up | — | 1.93 ± 1.03 | 1.84 ± 1.08 | 1.95 ± 1.07 | 1.65 ± 0.93 | — |
Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 2.17 ± 0.57 | 2.14 ± 0.50 | 2.12 ± 0.55 | 2.10 ± 0.51 | 2.13 ± 0.53 | 2.13 ± 0.44 |
| Session 3 | — | 2.29 ± 0.53 | 2.33 ± 0.53 | 2.27 ± 0.47 | 2.20 ± 0.49 | — |
| Session 5 | — | 2.29 ± 0.53 | 2.34 ± 0.51 | 2.25 ± 0.53 | 2.28 ± 0.52 | — |
| 2-month Follow-up | — | 2.22 ± 0.47 | 2.25 ± 0.52 | 2.26 ± 0.46 | 2.25 ± 0.50 | — |
Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 2.27 ± 0.93 | 2.27 ± 0.92 | 2.37 ± 0.83 | 2.22 ± 0.93 | 2.20 ± 0.93 | 2.15 ± 1.04 |
| Session 3 | — | 2.71 ± 0.84 | 2.75 ± 0.85 | 2.59 ± 0.81 | 2.41 ± 0.83 | — |
| Session 5 | — | 2.77 ± 0.81 | 2.75 ± 0.79 | 2.74 ± 0.84 | 2.57 ± 0.88 | — |
| 2-month Follow-up | — | 2.75 ± 0.75 | 2.82 ± 0.74 | 2.75 ± 0.78 | 2.58 ± 0.80 | — |
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life. Participants are asked "All things considered, how satisfied are you with your life as a whole?" and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 4.71 ± 2.28 | 4.77 ± 2.22 | 5.09 ± 2.16 | 4.95 ± 2.14 | 5.01 ± 2.18 | 4.31 ± 2.50 |
| Session 3 | — | 5.69 ± 2.21 | 5.75 ± 2.05 | 5.94 ± 1.99 | 5.28 ± 2.13 | — |
| Session 5 | — | 5.81 ± 2.32 | 6.00 ± 2.08 | 6.01 ± 1.91 | 5.79 ± 2.05 | — |
| 2-month Follow-up | — | 5.71 ± 2.16 | 6.12 ± 2.05 | 6.14 ± 2.03 | 5.76 ± 1.91 | — |
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility. Participants are asked "I often look at a situation from different viewpoints." with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 5.20 ± 1.41 | 5.20 ± 1.43 | 5.25 ± 1.38 | 5.17 ± 1.51 | 5.04 ± 1.44 | 5.54 ± 1.05 |
| Session 3 | — | 5.41 ± 1.31 | 5.60 ± 1.33 | 5.41 ± 1.35 | 5.36 ± 1.24 | — |
| Session 5 | — | 5.40 ± 1.40 | 5.61 ± 1.35 | 5.52 ± 1.23 | 5.33 ± 1.26 | — |
| 2-month Follow-up | — | 5.59 ± 1.15 | 5.57 ± 1.19 | 5.57 ± 1.20 | 5.47 ± 1.26 | — |
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance. Participants are asked "I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them." with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 4.05 ± 1.75 | 3.78 ± 1.66 | 3.89 ± 1.63 | 3.85 ± 1.64 | 3.80 ± 1.55 | 3.85 ± 1.41 |
| Session 3 | — | 4.33 ± 1.60 | 4.44 ± 1.60 | 3.94 ± 1.57 | 4.14 ± 1.53 | — |
| Session 5 | — | 4.56 ± 1.55 | 4.72 ± 1.41 | 4.43 ± 1.56 | 4.25 ± 1.48 | — |
| 2-month Follow-up | — | 4.58 ± 1.51 | 4.73 ± 1.54 | 4.17 ± 1.61 | 4.35 ± 1.43 | — |
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal. Participants are given two statements - "When I want to feel more positive emotion, I change the way I'm thinking about the situation" and "When I want to feel less negative emotion, I change the way I'm thinking about the situation" - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 4.41 ± 1.57 | 4.28 ± 1.49 | 4.34 ± 1.42 | 4.29 ± 1.41 | 4.14 ± 1.36 | 4.65 ± 1.05 |
| Session 3 | — | 4.90 ± 1.25 | 4.81 ± 1.44 | 4.79 ± 1.28 | 4.59 ± 1.33 | — |
| Session 5 | — | 5.11 ± 1.28 | 4.95 ± 1.20 | 4.89 ± 1.32 | 4.87 ± 1.29 | — |
| 2-month Follow-up | — | 5.00 ± 1.20 | 4.96 ± 1.18 | 5.01 ± 1.18 | 4.92 ± 1.11 | — |
Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 5.42 ± 1.27 | 5.57 ± 1.11 | 5.56 ± 1.14 | 5.65 ± 1.12 | 5.53 ± 1.23 | 5.62 ± 1.16 |
| Session 3 | — | 5.22 ± 1.20 | 5.18 ± 1.19 | 5.29 ± 1.17 | 5.44 ± 1.20 | — |
| Session 5 | — | 5.00 ± 1.37 | 5.08 ± 1.14 | 5.03 ± 1.21 | 5.25 ± 1.22 | — |
| 2-month Follow-up | — | 5.10 ± 1.31 | 5.16 ± 1.20 | 5.02 ± 1.20 | 5.26 ± 1.19 | — |
We will assess change in the extent anxiety is viewed as central to the person's self-concept. Participants are asked "To what extent is your anxiety a central part of who you are currently?" and provided with 5 images of two circles, one labeled "My Anxiety" and one labeled "Me", where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety.
| score on a scale | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures |
|---|---|---|---|---|---|---|
| Baseline | 2.48 ± 0.93 | 2.55 ± 0.90 | 2.51 ± 0.88 | 2.56 ± 0.85 | 2.49 ± 0.98 | 2.42 ± 0.79 |
| Session 3 | — | 1.93 ± 0.93 | 1.86 ± 0.92 | 2.01 ± 0.90 | 2.12 ± 0.95 | — |
| Session 5 | — | 1.61 ± 1.00 | 1.69 ± 0.79 | 1.75 ± 0.99 | 1.83 ± 0.94 | — |
| 2-month Follow-up | — | 1.57 ± 0.88 | 1.54 ± 0.85 | 1.57 ± 0.89 | 1.78 ± 1.01 | — |
Collected over Adverse event data was monitored throughout the study, through study completion (during the 5-6 weeks of active study sessions and at 2 month follow-up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| Received CBM-I and Classified Low Attrition | 0/288 (0%) | 0/288 (0%) | 0/288 (0%) |
| Received CBM-I and Classified High Attrition and no Coach Given | 0/265 (0%) | 0/265 (0%) | 0/265 (0%) |
| Received CBM-I and Classified High Attrition and Given a Coach | 0/282 (0%) | 0/282 (0%) | 0/282 (0%) |
| Psychoeducation | 0/242 (0%) | 0/242 (0%) | 0/242 (0%) |
| Psychoeducation, Lacking Classification Measures | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Not Randomized to Treatment | 0/509 (0%) | 0/509 (0%) | 0/509 (0%) |
A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of baseline participants is slightly below the enrollment #. Participants not randomized to treatment often did not complete demographic information and were not included in analyses.
| Age, Continuous(years) | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 34.16 ± 12.09 | 37.2 ± 12.33 | 34.24 ± 11.13 | 34.37 ± 11.9 | 35.09 ± 12.3 | 31.54 ± 10.44 | — | 28.50 ± 3.32 | 35.09 ± 11.97 |
| Sex/Gender, Customized(Participants) | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 112 | 237 | 217 | 231 | 194 | 11 | — | 1 | 1003 |
| Male | 33 | 45 | 38 | 43 | 41 | 2 | — | 3 | 205 |
| Transgender | 0 | 0 | 2 | 2 | 1 | 0 | — | 0 | 5 |
| Transgender Female | 0 | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 |
| Transgender Male | 0 | 1 | 2 | 0 | 1 | 0 | — | 0 | 4 |
| Other | 2 | 4 | 4 | 4 | 2 | 0 | — | 0 | 16 |
| Prefer not to answer | 1 | 1 | 0 | 1 | 2 | 0 | — | 1 | 6 |
| Race/Ethnicity, Customized(Participants) | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 22 | 40 | 31 | 38 | 30 | 3 | — | 0 | 164 |
| Ethnicity — Not Hispanic or Latino | 118 | 230 | 224 | 236 | 201 | 10 | — | 2 | 1021 |
| Ethnicity — Unknown | 3 | 7 | 4 | 5 | 2 | 0 | — | 1 | 22 |
| Ethnicity — Prefer not to answer | 5 | 11 | 4 | 2 | 8 | 0 | — | 2 | 32 |
| Race/Ethnicity, Customized(Participants) | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|---|
| Race — American Indian/Alaska Native | 1 | 3 | 3 | 1 | 1 | 0 | — | 0 | 9 |
| Race — Black/African origin | 12 | 31 | 27 | 19 | 31 | 2 | — | 0 | 122 |
| Race — East Asian | 4 | 5 | 7 | 11 | 9 | 0 | — | 1 | 37 |
| Race — Native Hawaiian/Pacific Islander | 1 | 2 | 1 | 0 | 0 | 0 | — | 0 | 4 |
| Race — South Asian | 3 | 4 | 6 | 5 | 7 | 2 | — | 2 | 29 |
| Race — White/European origin | 95 | 211 | 185 | 212 | 179 | 8 | — | 1 | 891 |
| Race — More than one race | 18 | 18 | 22 | 24 | 5 | 0 | — | 0 | 87 |
| Race — Other or Unknown | 12 | 10 | 10 | 6 | 4 | 1 | — | 0 | 43 |
| Race — Prefer not to answer | 2 | 4 | 2 | 3 | 5 | 0 | — | 1 | 17 |
| Country(Participants) | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Not Randomized to Treatment | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 133 | 256 | 251 | 259 | 214 | 12 | — | 2 | 1127 |
| Australia | 4 | 17 | 8 | 10 | 12 | 1 | — | 0 | 52 |
| United Kingdom | 3 | 4 | 1 | 0 | 4 | 0 | — | 1 | 13 |
| Canada | 3 | 4 | 1 | 1 | 3 | 0 | — | 0 | 12 |
| Other | 4 | 7 | 2 | 11 | 7 | 0 | — | 1 | 32 |
| Prefer not to answer | 1 | 0 | 0 | 0 | 1 | 0 | — | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data will be shared on the NIMH Data Archive.
Time frame: Data will be shared within one year of completion of the main trial.
Access criteria: We will follow the standard access criteria for the NIMH Data Archive.
Data sharing details ↗ · data-archive.nimh.nih.gov
Ran from Jan 2019 to primary completion in Dec 2020, 22 months.
Results were first posted in Feb 2025, 4 years 2 months after primary completion.
Of 81 non-industry phase 2 interventional studies under Anxiety Disorders, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 63. This study's 22 months is below that.
Counting every sponsor, half of 96 studies reached it within 35 months; a quarter within 18 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.