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 — BEHAVIORAL
    This 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-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.
  • 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.

Primary Outcome Measure

Participant recruitment [ Time Frame: Baseline, 16-20 weeks post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Maribel Plasencia, PhD
713-440-4400
Maribel Plasencia, BA MS PhD (PRINCIPAL_INVESTIGATOR)

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