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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

Must not have

Veterans currently receiving psychotherapy for anxiety at the time of enrollment WILL be excluded so as not to duplicate services (Current treatment will be defined as patients that have received a psychotherapy appointment within the last 3 months)

Cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-, 8-, and 12-month

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently in psychotherapy for anxiety.

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I have difficulty with memory or thinking clearly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-, 8-, and 12-month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GAD-7 Change

Secondary study objectives

OASIS Change

SF-12 Change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 2

~170

0 / 2Eligibility criteria met