Behavioral Activation-Guided Self-Help for Depression

Overseen By Brenda Salgado, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: High GAD-7 score, Psychotherapy, Suicidal ideation, Cognitive impairment, Uncontrolled psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16-20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Maribel Plasencia, BA MS PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must be patients at the study site

Participants must score a 10 to 20 on the PHQ-9 (moderate to moderately severe)

Participants must be able to follow the self-help program, which requires reading materials in English and documenting/tracking work between meetings with a provider

Exclusion Criteria

I do not have cognitive problems that would prevent me from finishing the program.

Participants with conditions that threaten safety (e.g., uncontrolled psychosis, mania/bipolar, moderate to severe substance use disorders)

Participants with a score greater than 10 on the GAD-7

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation-Guided Self-Help (BA-GSH) or Enhanced Usual Care for depression

16-20 weeks

Regular coaching sessions (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation-Guided Self-Help

How Is the Trial Designed?

Group I: Behavioral Activation-Guided Self-Help Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+