Pilot Randomized Trial of Behavioral Activation-Guided Self-Help for Depression in VA Primary Care-Mental Health Integration (HSR4-024-25M)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Participant recruitment
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Behavioral Activation-Guided Self-Help (Behavioral)
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.
Outcomes
Primary Outcomes
Participant recruitment
Time Frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients recruited into the study program over the number of patients potentially eligible.
Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 16-20 weeks post-baseline
The PHQ-9 measures depressive symptom severity over the previous two weeks. Participants self-report how often they have experienced a particular symptom on a scale of 0 to 3 (0 = not at all and 3 = nearly every day).
Attrition
Time Frame: Baseline, 16-20 weeks post-baseline
This proportion will be presented as the number of patients who discontinue the program over the total number of recruited participants over the trial period.
Client Satisfaction Questionnaire-8
Time Frame: 16-20 weeks post-baseline
The CSQ-8 evaluates general satisfaction with a service and scores range from 8 to 32. Higher scores indicate higher satisfaction.
Program Completion
Time Frame: 16-20 weeks post-baseline
This proportion will be presented as the number of patients who complete 70% of the intervention over the total number of patients recruited into the study arm.
Secondary Outcomes
- Preliminary Effectiveness: Beck Depression Inventory-II(Baseline, 16-20 weeks post-baseline)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, 16-20 weeks post-baseline)
- Quality of Life Scale (QOLS)(Baseline, 16-20 weeks post-baseline)
- Veterans Rand-12 (VR-12)(Baseline, 16-20 weeks post-baseline)