Cognitive Bias Modification - Interpretation training for Anxiety

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia), Charlottesville, VAAnxietyCognitive Bias Modification - Interpretation training - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two methods of delivering cognitive behavioral therapy for insomnia (CBT-I) - via computer or mobile phone - to see which is more effective. They will also test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.

Eligible Conditions
  • Anxiety

Treatment Effectiveness

Study Objectives

4 Primary · 11 Secondary · Reporting Duration: 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.

Month 2
Change in Alcohol Use Comorbid symptoms
Anxiety
Change in Brief Bodily Sensations Interpretations Questionnaire
Comorbidity
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Change in Mechanisms underlying bias change - Cognitive flexibility
Change in Mechanisms underlying bias change - Cognitive reappraisal
Change in Mechanisms underlying bias change - Experiential avoidance
Change in Mechanisms underlying bias change - Intolerance of uncertainty
Change in Recognition Ratings
Change in Wellness measures - Growth mindset
Change in Wellness measures - Life Satisfaction
Change in Wellness measures - Optimism
Change in Wellness measures - Self-efficacy
Month 2
Change in Overall Anxiety Severity and Impairment Scale

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Psychoeducation
1 of 4
CBM-I, high attrition, coach
1 of 4
CBM-I, high attrition, no coach
1 of 4
CBM-I, low attrition
1 of 4

Active Control

Experimental Treatment

840 Total Participants · 4 Treatment Groups

Primary Treatment: Cognitive Bias Modification - Interpretation training · No Placebo Group · Phase 2

CBM-I, high attrition, coachExperimental Group · 2 Interventions: Coaching, Cognitive Bias Modification - Interpretation training · Intervention Types: Behavioral, Behavioral
CBM-I, high attrition, no coach
Behavioral
Experimental Group · 1 Intervention: Cognitive Bias Modification - Interpretation training · Intervention Types: Behavioral
CBM-I, low attrition
Behavioral
Experimental Group · 1 Intervention: Cognitive Bias Modification - Interpretation training · Intervention Types: Behavioral
Psychoeducation
Behavioral
ActiveComparator Group · 1 Intervention: Online psychoeducation about anxiety · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coaching
2016
Completed Phase 3
~5600

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

University of VirginiaLead Sponsor
694 Previous Clinical Trials
1,466,641 Total Patients Enrolled
3 Trials studying Anxiety
1,014 Patients Enrolled for Anxiety
Bethany Teachman, PhDPrincipal InvestigatorUniv. of Virginia
1 Previous Clinical Trials
233 Total Patients Enrolled
1 Trials studying Anxiety
233 Patients Enrolled for Anxiety

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a smartphone or computer with an internet connection.

Frequently Asked Questions

How many people are agreed to be a part of this testing?

"That is correct. The website provides evidence that the trial is presently looking for 840 patients at 1 locations." - Anonymous Online Contributor

Unverified Answer

Are people still being recruited to participate in this experiment?

"Yes, the most recent data from clinicaltrials.gov suggests that this trial is currently looking for participants. The trial was first posted on 1/20/2019 and updated as recently as 11/8/2022. They are recruiting 840 individuals from a single site." - Anonymous Online Contributor

Unverified Answer

What are the investigators of this study hoping to discover?

"The primary outcome of this trial will be Change in Recognition Ratings, which will be evaluated over a 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). The secondary outcomes include Change in Depression Comorbid symptoms, Change in Anxiety and Identity Circles, and Change in Mechanisms underlying bias change - Experiential avoidance." - Anonymous Online Contributor

Unverified Answer

Does the FDA sanction Cognitive Bias Modification - Interpretation training?

"While Phase 2 trials have not yet provided evidence for efficacy, there is some data supporting the safety of Cognitive Bias Modification - Interpretation training. For this reason, our team has given it a score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.