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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation-Guided Self-Help | Experimental | 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. |
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| Enhanced Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment | This proportion will be presented as the number of patients recruited into the study program over the number of patients potentially eligible. | Baseline, 16-20 weeks post-baseline |
| Preliminary Effectiveness: Patient Health Questionnaire-9 (PHQ-9) | 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). | Baseline, 16-20 weeks post-baseline |
| Attrition | 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. | Baseline, 16-20 weeks post-baseline |
| Client Satisfaction Questionnaire-8 | The CSQ-8 evaluates general satisfaction with a service and scores range from 8 to 32. Higher scores indicate higher satisfaction. | 16-20 weeks post-baseline |
| Program Completion | 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. | 16-20 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Effectiveness: Beck Depression Inventory-II | The BDI-II is a 21-item measure of depressive symptoms where individuals report the severity of their symptoms over the past two weeks. | Baseline, 16-20 weeks post-baseline |
| Generalized Anxiety Disorder-7 (GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maribel Plasencia, PhD | Contact | (713) 440-4400 | maribel.plasencia@va.gov | |
| Brenda Salgado, BS | Contact | (713) 791-1414 | brenda.salgado@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Maribel Plasencia, BA MS PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The GAD-7 measures anxiety symptom severity over the previous two weeks. Participants rate the frequency of their symptoms from 0 to 3 (0 = not at all and 3 = nearly every day). |
| Baseline, 16-20 weeks post-baseline |
| Quality of Life Scale (QOLS) | The QOLS is a 16-item measure in which participants report their level of satisfaction (7 = delighted and 1 = terrible) with various aspects of life (e.g., close friends). | Baseline, 16-20 weeks post-baseline |
| Veterans Rand-12 (VR-12) | The VR-12, formerly known as the Veterans SF-12, is a measure derived from the RAND 12-Item Health Survey (SF-12). This instrument measures Health Related Quality of Life by asking participants about their health and the extent to which physical or emotional problems interfere with various activities | Baseline, 16-20 weeks post-baseline |