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

Official title

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

Overview

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.

Detailed description

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 behavioral intervention with coaching from a provider. A meta-analysis found that GSH is as effective as traditional psychotherapy treatments for depression and anxiety disorders. VHA's Primary Care Mental Health-Integration (PCMHI) Service may be the ideal setting in which to deploy GSH. However, GSH is not widely used within VHA, and existing CBT interventions for depression require adaptation to the GSH format and PCMHI setting.

The specific aim of this project is to conduct a pilot randomized trial of Behavioral Activation-GSH (BA-GSH) for depression (15 Veterans assigned to BA-GSH; 15 assigned to treatment as usual) in PCMHI by a variety of types of providers within this setting. This pilot will evaluate the acceptability and feasibility of BA-GSH and explore preliminary effectiveness.

Interventions

• Behavioral Behavioral Activation-Guided Self-Help
  This intervention is based on behavioral activation. It includes a self-help program that is paired with guidance from a provider.

Primary outcome measures

• Participant recruitment [Time frame: Baseline, 16-20 weeks post-baseline]
• Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, 16-20 weeks post-baseline]
• Attrition [Time frame: Baseline, 16-20 weeks post-baseline]
• Client Satisfaction Questionnaire-8 [Time frame: 16-20 weeks post-baseline]
• Program Completion [Time frame: 16-20 weeks post-baseline]

Secondary outcome measures (4)

• Preliminary Effectiveness: Beck Depression Inventory-II [Time frame: Baseline, 16-20 weeks post-baseline]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline, 16-20 weeks post-baseline]
• Quality of Life Scale (QOLS) [Time frame: Baseline, 16-20 weeks post-baseline]
• Veterans Rand-12 (VR-12) [Time frame: Baseline, 16-20 weeks post-baseline]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

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

Identifiers

NCT: NCT07541482 · HSR4-024-25M-T

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗