Pilot Randomized Trial of BA-GSH in VA PC-MHI (NCT07541482)
Pilot Randomized Trial of Behavioral Activation-Guided Self-Help for Depression in VA Primary Care-Mental Health Integration (HSR4-024-25M)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
- Behavioral Activation-Guided Self-Help (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas
📞 Contact the Study Coordinator
Phone: (713) 440-4400
Email: maribel.plasencia@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Depression
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- Cognition and Behavior With Sham Accelerated TMS — Sacramento, California
- Meditation Accelerated Brain Stimulation for Depression — San Diego, California
Explore by condition: All Depression clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.