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NCT Number: NCT07541482

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location contact

Maribel Plasencia, BA MS PhD

PRINCIPAL_INVESTIGATOR

Maribel Plasencia, PhD

CONTACT

[email protected]

713-440-4400

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brenda Salgado, BS

CONTACT

[email protected]

(713) 791-1414

Maribel Plasencia, PhD

CONTACT

[email protected]

(713) 440-4400

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2031
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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