Pilot Randomized Trial of BA-GSH in VA PC-MHI

April 14, 2026 updated by: VA Office of Research and Development

Pilot Randomized Trial of Behavioral Activation-Guided Self-Help for Depression in VA Primary Care-Mental Health Integration (HSR4-024-25M)

Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Elevated symptoms of depression in approximately 10% of Veterans and are associated with functional impairment and suicidality. Cognitive behavioral therapy (CBT) is a first line intervention for these conditions, yet few Veterans receive this treatment, in part due to the limited availability of mental health providers trained in CBT. The stepped care model offers one approach to addressing access by offering effective yet less resource-intensive treatments upon entry into mental health care for individuals with mild to moderate symptoms, stepping up the intensity and level of care as needed. Guided self-help (GSH) is one low intensity treatment format that could increase accessibility of CBT for depression and GAD. In GSH, patients follow a self-help version of an evidence-based behavioral intervention with coaching from a provider. A meta-analysis found that GSH is as effective as traditional psychotherapy treatments for depression and anxiety disorders. VHA's Primary Care Mental Health-Integration (PCMHI) Service may be the ideal setting in which to deploy GSH. However, GSH is not widely used within VHA, and existing CBT interventions for depression require adaptation to the GSH format and PCMHI setting.

The specific aim of this project is to conduct a pilot randomized trial of Behavioral Activation-GSH (BA-GSH) for depression (15 Veterans assigned to BA-GSH; 15 assigned to treatment as usual) in PCMHI by a variety of types of providers within this setting. This pilot will evaluate the acceptability and feasibility of BA-GSH and explore preliminary effectiveness.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
        • Principal Investigator:
          • Maribel Plasencia, BA MS PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • participants will be included in the study if they are patients at the study site
  • score a 10 to 20 on the PHQ-9 (moderate to moderately severe)
  • can follow the self-help program, which requires reading materials in English and documenting/tracking work between meetings with a provider

Exclusion Criteria:

  • score greater than 10 on the GAD-7
  • PCMHI ineligible (i.e., in specialty mental health)
  • currently enrolled in a VA or non-VA psychotherapy that would interfere with the study intervention
  • participants will also be excluded if demonstrating high risk of suicidal ideation/behavior based on the C-SSRS
  • cognitive impairment conditions that may interfere with the ability to complete the program
  • conditions that threaten safety (e.g., uncontrolled psychosis, mania/bipolar, moderate to severe substance use disorders)

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Activation-Guided Self-Help
For this arm, participants will work through a self-help program based on behavioral activation paired with guidance from a provider in VA Primary Care-Mental Health Integration.
Behavioral: Behavioral Activation-Guided Self-Help
This intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider.
No Intervention: Enhanced Usual Care
For this arm, a note will be entered into the participants medical record that indicates the participant's enrollment in the study and documents whether depression scores are elevated. This note includes a statement that encourages providers to deliver care in their usual and customary fashion and actively monitor aspects related to depression as part of the patient's overall care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant recruitment
Time Frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients recruited into the study program over the number of patients potentially eligible.
Baseline, 16-20 weeks post-baseline
Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 16-20 weeks post-baseline
The PHQ-9 measures depressive symptom severity over the previous two weeks. Participants self-report how often they have experienced a particular symptom on a scale of 0 to 3 (0 = not at all and 3 = nearly every day).
Baseline, 16-20 weeks post-baseline
Attrition
Time Frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients who discontinue the program over the total number of recruited participants over the trial period.
Baseline, 16-20 weeks post-baseline
Client Satisfaction Questionnaire-8
Time Frame: 16-20 weeks post-baseline
The CSQ-8 evaluates general satisfaction with a service and scores range from 8 to 32. Higher scores indicate higher satisfaction.
16-20 weeks post-baseline
Program Completion
Time Frame: 16-20 weeks post-baseline
This proportion will be presented as the number of patients who complete 70% of the intervention over the total number of patients recruited into the study arm.
16-20 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Effectiveness: Beck Depression Inventory-II
Time Frame: Baseline, 16-20 weeks post-baseline
The BDI-II is a 21-item measure of depressive symptoms where individuals report the severity of their symptoms over the past two weeks.
Baseline, 16-20 weeks post-baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, 16-20 weeks post-baseline
The GAD-7 measures anxiety symptom severity over the previous two weeks. Participants rate the frequency of their symptoms from 0 to 3 (0 = not at all and 3 = nearly every day).
Baseline, 16-20 weeks post-baseline
Quality of Life Scale (QOLS)
Time Frame: Baseline, 16-20 weeks post-baseline
The QOLS is a 16-item measure in which participants report their level of satisfaction (7 = delighted and 1 = terrible) with various aspects of life (e.g., close friends).
Baseline, 16-20 weeks post-baseline
Veterans Rand-12 (VR-12)
Time Frame: Baseline, 16-20 weeks post-baseline
The VR-12, formerly known as the Veterans SF-12, is a measure derived from the RAND 12-Item Health Survey (SF-12). This instrument measures Health Related Quality of Life by asking participants about their health and the extent to which physical or emotional problems interfere with various activities
Baseline, 16-20 weeks post-baseline

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: Maribel Plasencia, BA MS PhD, Michael E. DeBakey VA Medical Center, Houston, TX

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 (Estimated)

October 15, 2027

Primary Completion (Estimated)

July 15, 2029

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR4-024-25M-T

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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