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

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Anxiety

Treatments: Behavioral: Brief Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04523779

CIRB 20-22 (Other Identifier)

IIR 18-233

HX-002796 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 2 patient groups

Brief Cognitive Behavioral Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Cognitive Behavioral Therapy

Enhanced Usual Care

No Intervention group

Description:

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).