Pilot Randomized Trial of BA-GSH in VA PC-MHI
Part of paid clinical trials in Houston, Texas.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT07541482
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Activation-Guided Self-Help — BEHAVIORALThis intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider.
Study Details
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.
Key Dates
- Start date
- Oct 15, 2027
- Status verified
- Apr 2026
- Primary completion
- Jul 15, 2029
- Completion
- Jun 30, 2031
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Behavioral Activation-Guided Self-HelpFor 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.
- No Intervention: Enhanced Usual CareFor 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.
Primary Outcome Measure
Participant recruitment [ Time Frame: Baseline, 16-20 weeks post-baseline ]
Central Contacts
- Maribel Plasencia, PhD(713) 440-4400
- Brenda Salgado, BS(713) 791-1414
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | Maribel Plasencia, BA MS PhD (PRINCIPAL_INVESTIGATOR) |
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