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Behavioral Intervention

Cognitive Bias Modification - Interpretation training for Anxiety

Phase 2

Recruiting

Led By Bethany Teachman, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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 trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Brief Bodily Sensations Interpretations Questionnaire

Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale

Change in Overall Anxiety Severity and Impairment Scale

+1 more

Secondary outcome measures

Change in Alcohol Use Comorbid symptoms

Anxiety

Comorbidity

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: CBM-I, low attritionExperimental Treatment1 Intervention

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Group II: CBM-I, high attrition, no coachExperimental Treatment1 Intervention

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Group III: CBM-I, high attrition, coachExperimental Treatment2 Interventions

Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching

Group IV: PsychoeducationActive Control1 Intervention

Online psychoeducation about anxiety

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coaching

2016

Completed Phase 3

~5600

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,191 Total Patients Enrolled

4 Trials studying Anxiety

1,314 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bethany A. Teachman, Ph.D. 2019. "Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03498651.