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

Sponsored by VA Office of Research and Development

About this study

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.

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 behavior…

Where this study is enrolling

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas

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Who can participate

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)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.