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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a guided self-help program for Veterans with depression in VA primary care mental health services. The program uses behavioral activation, which helps people take part in activities, along with coaching sessions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a patient at the study site.
  • You score 10 to 20 on the PHQ-9, a survey that measures depression symptoms.
  • You can read the program materials in English and write down or track your work between visits with a provider.

Who can't join

  • You score above 10 on the GAD-7, a survey that measures anxiety symptoms.
  • You do not qualify for primary care mental health services, such as because you are in specialty mental health care.
  • You are getting talk therapy through the VA or elsewhere that would interfere with the study program.
  • A suicide risk check called the C-SSRS shows a high risk of suicidal thoughts or actions.
  • You have thinking or memory problems that may keep you from completing the program.
  • You have a condition that threatens safety, such as uncontrolled psychosis (trouble knowing what is real), mania or bipolar disorder (extreme mood changes), or moderate to severe alcohol or drug use problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

TX