A Pragmatic Trial of Brief CBT for Anxiety in VA Primary Care

April 5, 2024 updated by: VA Office of Research and Development
This 4-year study will examine the value of a type of a brief cognitive behavioral therapy treatment for Veterans with anxiety and worry. This treatment will be delivered either in-person, or by video telehealth to the Veteran's home. The treatment will be delivered by providers at three Veterans Administration Medical Centers (Houston, New Orleans, and San Antonio). The study will compare the helpfulness of this treatment to the usual care Veterans receive for anxiety and worry. A supplement to this study will also evaluate daily discrimination experiences of Veterans based on the participant's race, ethnicity, religion, physical appearance, or other characteristics.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This 4-year, multisite trial (Houston, New Orleans and San Antonio) will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief cognitive behavioral therapy(bCBT) intervention for anxiety delivered either in-person or via VA Video Connect-Home (VVC-H), according to patient preference. Brief CBT will be delivered by existing Primary Care Mental Health Integration (PCMHI) providers at three large VAMCs (Houston, New Orleans, and San Antonio). Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. Enhanced Usual Care (EUC) for anxiety at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. The primary hypothesis is that anxiety outcomes, as measured by the General Anxiety Disorder 7-item scale (GAD-7) will be superior at 4-, 8-, and 12-month follow up for patients who are assigned to receive bCBT vs. EUC.

In addition, participants will be asked to complete the Diversity Supplement measures and qualitative interview to evaluate whether sociocultural factors are associated with the severity and type of anxiety symptoms among Veterans of different race/ethnicity groups.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Southeast Louisiana Veterans Health Care System, New Orleans, LA
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Michael E. DeBakey VA Medical Center, Houston, TX
      • San Antonio, Texas, United States, 78229
        • South Texas Health Care System, San Antonio, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be a United States military Veteran
  • Veteran participants will be current recipients of services at the Houston, New Orleans, or San Antonio VA Medical Centers.
  • Patients who have received Primary Care Mental Health Integration services, or are eligible for PCMHI services (They are not receiving specialty mental health services)
  • Veterans with clinically significant symptoms of anxiety will be included after screening on two occasions to ensure consistency of anxiety symptoms (GAD-7 score of 10 or greater; telephone screen and baseline appointment).

Exclusion Criteria:

  • Cognitive impairment
  • Presence of bipolar, psychotic or substance-abuse disorders.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief Cognitive Behavioral Therapy
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.
Behavioral: Brief Cognitive Behavioral Therapy
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.
Other Names:
  • bCBT
No Intervention: Enhanced Usual Care
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAD-7 Change
Time Frame: Baseline, 4-, 8-, and 12-month
The GAD-7 is a seven-item self-report instrument for screening, diagnosis and severity assessment of anxiety disorder. It is psychometrically strong and valid for use in the primary care setting. A GAD-7 score of 10 or higher will be required for study inclusion. Treatment response will be defined as a 50% reduction in baseline GAD-7 scores. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
Baseline, 4-, 8-, and 12-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OASIS Change
Time Frame: Baseline, 4-, 8-, and 12-month
The Overall Anxiety Severity and Impairment Scale (OASIS) will be a secondary measure of anxiety. Unlike the GAD-7, which will be administered by both research staff and PCMHI providers, the OASIS will only be administered by research staff, thereby avoiding response bias that may occur in the clinical setting. The OASIS is a widely used five-item measure of anxiety for primary care settings assessing anxiety frequency, anxiety severity, avoidance behaviors, social interference, and interference at work, school, or home. Each item of the OASIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. A higher score indicates a poorer outcome.
Baseline, 4-, 8-, and 12-month
SF-12 Change
Time Frame: Baseline, 4-, 8-, and 12-month
The SF-12 is a self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical and Mental Health Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF-12V18), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning.
Baseline, 4-, 8-, and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Terri L. Fletcher, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Estimated)

March 14, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 18-233
  • HX-002796 (Other Grant/Funding Number: VA Health Services Research)
  • CIRB 20-22 (Other Identifier: VA Central Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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