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

NCT07541482 | Not Yet Recruiting

• 1 other identifier: HSR4-024-25M-T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (5)

• Participant recruitment

  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)

  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

  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

  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

  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 Outcomes (4)

• Preliminary Effectiveness: Beck Depression Inventory-II

  Baseline, 16-20 weeks post-baseline

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, 16-20 weeks post-baseline

• Quality of Life Scale (QOLS)

  Baseline, 16-20 weeks post-baseline

• Veterans Rand-12 (VR-12)

  Baseline, 16-20 weeks post-baseline

Study Arms (2)

Behavioral Activation-Guided Self-Help

EXPERIMENTAL

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

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

Behavioral Activation-Guided Self-Help BEHAVIORAL

This intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider.

Behavioral Activation-Guided Self-Help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Maribel Plasencia, BA MS PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maribel Plasencia, PhD

CONTACT

(713) 440-4400; maribel.plasencia@va.gov

Brenda Salgado, BS

CONTACT

(713) 791-1414; brenda.salgado@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): October 15, 2027
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)