AnxietyPhase 2NCT03498651

Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition

A Phase 2 study testing Cognitive Bias Modification - Interpretation training, Coaching and Online psychoeducation about anxiety in people with Anxiety, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety
What is being tested?: Cognitive Bias Modification - Interpretation training, Coaching and Online psychoeducation about anxiety
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,748 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2019to 3 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 18 and over
Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale
Regular access to the Internet via Smartphone or computer

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia)
Charlottesville, Virginia, 22904

Other trials in United States

About this study

Official title: Effectiveness of Interpretation of Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition

Read the detailed description

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.

Conditions: Anxiety
Being tested: Cognitive Bias Modification - Interpretation training, Coaching, Online psychoeducation about anxiety
Keywords: Anxiety, Cognitive bias, Telemedicine
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Bias Modification - Interpretation trainingBehavioural
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.
CoachingBehavioural
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.
Online psychoeducation about anxietyBehavioural
Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.

Study groups in NCT03498651
Study group	Role	What they receive
CBM-I, low attrition	Experimental	Computer- or phone-based Cognitive Bias Modification - Interpretation training Receives: Behavioral: Cognitive Bias Modification - Interpretation training
CBM-I, high attrition, coach	Experimental	Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching Receives: Behavioral: Cognitive Bias Modification - Interpretation training; Behavioral: Coaching
CBM-I, high attrition, no coach	Experimental	Computer- or phone-based Cognitive Bias Modification - Interpretation training Receives: Behavioral: Cognitive Bias Modification - Interpretation training
Psychoeducation	Active comparator	Online psychoeducation about anxiety Receives: Behavioral: Online psychoeducation about anxiety

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Secondary outcomes (11)

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20193 Dec 2020

First posted17 Apr 2018
Study start20 Jan 2019
Primary completion3 Dec 2020
Study completion3 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Investigator
Enrolment: 1,748 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03498651
Sponsor's protocol ID: 2017-0234-00
Status last verified: Jan 2025
First submitted: 31 Mar 2018
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be shared on the NIMH Data Archive.

Publications

Eberle JW, Daniel KE, Baee S, Silverman AL, Lewis E, Baglione AN, Werntz A, French NJ, Ji JL, Hohensee N, Tong X, Huband JM, Boukhechba M, Funk DH, Barnes LE, Teachman BA. Web-based interpretation bias training to reduce anxiety: A sequential, multiple-assignment randomized trial. J Consult Clin Psychol. 2024 Jun;92(6):367-384. doi: 10.1037/ccp0000896.
PubMed 39023984

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Interpretation of Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
ClinicalTrials.gov ID: NCT03498651
Acronym / sponsor ID: 2017-0234-00
Conditions: Anxiety
Keywords: Anxiety, Cognitive bias, Telemedicine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,748 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Study start: 20 Jan 2019 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 3 Dec 2020 (actual)
First posted: 17 Apr 2018 (actual)
Results: Posted 19 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
CBM-I, low attrition	Experimental	Behavioral: Cognitive Bias Modification - Interpretation trainingComputer- or phone-based Cognitive Bias Modification - Interpretation training
CBM-I, high attrition, coach	Experimental	Behavioral: Cognitive Bias Modification - Interpretation training, Behavioral: CoachingComputer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
CBM-I, high attrition, no coach	Experimental	Behavioral: Cognitive Bias Modification - Interpretation trainingComputer- or phone-based Cognitive Bias Modification - Interpretation training
Psychoeducation	Active comparator	Behavioral: Online psychoeducation about anxietyOnline psychoeducation about anxiety

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18 and over
Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale
Regular access to the Internet via Smartphone or computer

Key exclusion criteria (1 listed)

None

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
Cognitive Bias Modification - Interpretation trainingTraining 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.	Behavioural	CBM-I, high attrition, coach, CBM-I, high attrition, no coach, CBM-I, low attrition
CoachingParticipants 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.	Behavioural	CBM-I, high attrition, coach
Online psychoeducation about anxietyParticipants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.	Behavioural	Psychoeducation

Primary outcome

Change in Recognition Ratings (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.
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.
Change in Recognition Ratings (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.
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.
Change in Brief Bodily Sensations Interpretations Questionnaire (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.
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.
Change in Brief Bodily Sensations Interpretations Questionnaire (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.
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.
Change in Overall Anxiety Severity and Impairment Scale
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.
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.
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
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.
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.

11 secondary outcomes

Change in Depression Comorbid Symptoms
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
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
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
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
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
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
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
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
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
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
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.

Results and safety

Results posted to the registry on 19 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Received CBM-I and Not Classified as High/Low Risk for Attrition	149	0
Received CBM-I and Classified Low Attrition	288	140
Received CBM-I and Classified High Attrition and no Coach Given	265	134
Received CBM-I and Classified High Attrition and Given a Coach	282	131
Psychoeducation	242	154
Psychoeducation, Lacking Classification Measures	13	0
Not Randomized to Treatment	509	0

Primary outcome: Change in Recognition Ratings (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.. Mean (Standard Deviation). Unit: units on a scale

Measure	Received CBM-I and Not Classified as High/Low Risk for Attrition n = 148	Received CBM-I and Classified Low Attrition n = 288	Received CBM-I and Classified High Attrition and no Coach Given n = 263	Received CBM-I and Classified High Attrition and Given a Coach n = 281	Psychoeducation n = 241	Psychoeducation, Lacking Classification Measures n = 13
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)	–

Received CBM-I and Not Classified as High/Low Risk for Attrition vs Received CBM-I and Classified Low Attrition vs Received CBM-I and Classified High Attrition and no Coach Given vs Psychoeducation vs Psychoeducation, Lacking Classification Measures: Mean Difference (Net): 1.10 (95% CI 1.04 to 1.16), Mixed Models Analysis
Received CBM-I and Classified High Attrition and no Coach Given vs Received CBM-I and Classified High Attrition and Given a Coach: Mean Difference (Net): -0.12 (95% CI -0.43 to 0.20), Mixed Models Analysis

Population analysed: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.

Primary outcome: Change in Recognition Ratings (Negative Interpretation Bias)

Measure	CBM-I, Not Classified as High/Low Risk for Attrition n = 148	CBM-I, Low Attrition n = 288	CBM-I, High Attrition, no Coach n = 263	CBM-I, High Attrition, Coach n = 281	Psychoeducation n = 241	Psychoeducation, Lacking Classification Measures n = 13
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)	–

CBM-I, Not Classified as High/Low Risk for Attrition vs CBM-I, Low Attrition vs CBM-I, High Attrition, no Coach vs Psychoeducation vs Psychoeducation, Lacking Classification Measures: Mean Difference (Net): -0.63 (95% CI -0.69 to -0.57), Mixed Models Analysis
CBM-I, High Attrition, no Coach vs CBM-I, High Attrition, Coach: Mean Difference (Net): 0.06 (95% CI -0.26 to 0.39), Mixed Models Analysis

Primary outcome: Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)

Measure	CBM-I, Not Classified as High/Low Risk for Attrition n = 148	CBM-I, Low Attrition n = 288	CBM-I, High Attrition, no Coach n = 263	CBM-I, High Attrition, Coach n = 281	Psychoeducation n = 241	Psychoeducation, Lacking Classification Measures n = 13
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)	–

CBM-I, Not Classified as High/Low Risk for Attrition vs CBM-I, Low Attrition vs CBM-I, High Attrition, no Coach vs Psychoeducation vs Psychoeducation, Lacking Classification Measures: Mean Difference (Net): 0.48 (95% CI 0.42 to 0.54), Mixed Models Analysis
CBM-I, High Attrition, no Coach vs CBM-I, High Attrition, Coach: Mean Difference (Net): 0.08 (95% CI -0.23 to 0.39), Mixed Models Analysis

Primary outcome: Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)

Measure	CBM-I, Not Classified as High/Low Risk for Attrition n = 148	CBM-I, Low Attrition n = 288	CBM-I, High Attrition, no Coach n = 263	CBM-I, High Attrition, Coach n = 281	Psychoeducation n = 241	Psychoeducation, Lacking Classification Measures n = 13
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)	–

CBM-I, Not Classified as High/Low Risk for Attrition vs CBM-I, Low Attrition vs CBM-I, High Attrition, no Coach vs Psychoeducation vs Psychoeducation, Lacking Classification Measures: Mean Difference (Net): -0.55 (95% CI -0.60 to -0.51), Mixed Models Analysis
CBM-I, High Attrition, no Coach vs CBM-I, High Attrition, Coach: Mean Difference (Net): 0.02 (95% CI -0.23 to 0.27), Mixed Models Analysis

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Received CBM-I and Not Classified as High/Low Risk for Attrition	0 of 149 (0%)	0 of 149 (0%)	0 of 149
Received CBM-I and Classified Low Attrition	0 of 288 (0%)	0 of 288 (0%)	0 of 288
Received CBM-I and Classified High Attrition and no Coach Given	0 of 265 (0%)	0 of 265 (0%)	0 of 265
Received CBM-I and Classified High Attrition and Given a Coach	0 of 282 (0%)	0 of 282 (0%)	0 of 282
Psychoeducation	0 of 242 (0%)	0 of 242 (0%)	0 of 242
Psychoeducation, Lacking Classification Measures	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Not Randomized to Treatment	0 of 509 (0%)	0 of 509 (0%)	0 of 509

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39023984Eberle JW, Daniel KE, Baee S, Silverman AL, Lewis E, Baglione AN, Werntz A, French NJ, Ji JL, Hohensee N, Tong X, Huband JM, Boukhechba M, Funk DH, Barnes LE, Teachman BA. Web-based interpretation bias training to reduce anxiety: A sequential, multiple-assignment randomized trial. J Consult Clin Psychol. 2024 Jun;92(6):367-384. doi: 10.1037/ccp0000896.
Individual participant dataSharing planned: Yes. De-identified data will be shared on the NIMH Data Archive.

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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.

Bethany Teachman, PhD principal investigator

Univ. of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 19 Feb 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Recognition Ratings (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.). 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 NCT03498651, 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 19 Feb 2025.