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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Anxiety

N/A
Waitlist Available
Led By Terri L. Fletcher, PhD
Research Sponsored by VA Office of Research and Development
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, 4-, 8-, and 12-month
Awards & highlights

Study Summary

This trial will study whether a type of cognitive behavioral therapy is helpful for Veterans with anxiety and worry, delivered either in-person or by video telehealth.

Who is the study for?
This trial is for U.S. military Veterans experiencing significant anxiety, who are currently receiving or eligible for mental health services at the Houston, New Orleans, or San Antonio VA Medical Centers. They must have consistent symptoms of anxiety confirmed by screenings and not be in psychotherapy for anxiety already. Those with bipolar, psychotic disorders, substance abuse issues, or cognitive impairments cannot join.Check my eligibility
What is being tested?
The study tests a brief form of Cognitive Behavioral Therapy (CBT) to treat anxiety in Veterans. It compares this treatment's effectiveness when done face-to-face versus via video telehealth against usual care methods. The impact of daily discrimination on therapy outcomes will also be assessed.See study design
What are the potential side effects?
While CBT typically has no direct physical side effects as it's a talking therapy, participants may experience temporary increases in distress as they confront and work through their anxieties during sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-, 8-, and 12-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-, 8-, and 12-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GAD-7 Change
Secondary outcome measures
OASIS Change
SF-12 Change

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Cognitive Behavioral TherapyExperimental Treatment1 Intervention
The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Group II: Enhanced Usual CareActive Control1 Intervention
EUC participants will receive anxiety education materials, a note in their medical record indicating the presence of elevated anxiety symptoms, and 4 brief monthly check-in calls with project staff. The primary outcome, anxiety symptoms, will be evaluated at 4-, 8- and 12-month follow-ups. Due to ethical concerns of withholding needed treatment, EUC participants will NOT be restricted from receiving mental health services including psychotherapy during the study period. The investigators fully expect that EUC participants may receive anxiety treatments (e.g., antianxiety and antidepressant medications or psychotherapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Cognitive Behavioral Therapy
2007
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,181 Total Patients Enrolled
17 Trials studying Anxiety
1,861 Patients Enrolled for Anxiety
Terri L. Fletcher, PhDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Brief Cognitive Behavioral Therapy (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04523779 — N/A
Anxiety Research Study Groups: Enhanced Usual Care, Brief Cognitive Behavioral Therapy
Anxiety Clinical Trial 2023: Brief Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT04523779 — N/A
Brief Cognitive Behavioral Therapy (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523779 — N/A
~53 spots leftby Mar 2025
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