Behavioral Activation-Guided Self-Help for Depression

MP
BS
Overseen ByBrenda Salgado, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new self-help program for Veterans with depression. The program uses behavioral activation, involving activities to boost mood and energy, guided by a provider. The goal is to make therapy more accessible for Veterans who might not receive enough mental health support. Veterans diagnosed with moderate depression who can read and track their progress in English might be a good fit for this trial. As an unphased trial, this study offers Veterans a unique opportunity to access innovative therapy methods that could enhance their mental health support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently enrolled in a psychotherapy program that would interfere with the study, you may not be eligible to participate.

What prior data suggests that this Behavioral Activation-Guided Self-Help is safe for Veterans with depression?

Research has shown that Behavioral Activation-Guided Self-Help for depression is generally well-tolerated. In one study, 3.7% of participants using this method reported increased suicidal thoughts, compared to 7.4% in a group receiving usual care. This finding suggests that the self-help method might be safer for mental health.

Behavioral activation is a therapy that encourages activities to improve mood. It has proven to be as effective as medication or traditional cognitive behavioral therapy (CBT) for treating depression. Additionally, it is easier to provide and costs less.

Overall, evidence suggests that this self-help program is safe, with fewer reports of increased suicidal thoughts compared to other methods. This makes it a promising option for managing depression symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation-Guided Self-Help for depression because it empowers individuals to take an active role in their mental health care. Unlike traditional therapies that often require regular sessions with a therapist, this approach allows participants to work through a self-help program at their own pace, with guidance from a healthcare provider. This method could increase accessibility and reduce the stigma associated with seeking mental health care, making it a promising option for those who may not have easy access to conventional therapy.

What evidence suggests that Behavioral Activation-Guided Self-Help is effective for depression?

Research has shown that Behavioral Activation-Guided Self-Help, which participants in this trial may receive, effectively reduces depression symptoms. One study found that participants experienced significant improvements in depression and stress, with a strong impact. Another study demonstrated that this treatment can be as effective as antidepressant medications. Additionally, digital versions of these treatments have improved quality of life and reduced depression symptoms, although these benefits might decrease over time. Overall, evidence supports the effectiveness of behavioral activation in helping people manage depression.678910

Who Is on the Research Team?

MP

Maribel Plasencia, BA MS PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for veterans with moderate to moderately severe depression who are patients at the study site. Participants must be able to read English and keep track of their progress, and cannot have serious mental health or substance use issues, cognitive problems, high anxiety, or be in other conflicting therapy programs.

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
See 3 more

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

Trial Overview

The study is testing a guided self-help program based on behavioral activation for depression. Veterans will receive coaching while following a structured self-help plan. The trial randomly assigns participants to groups to see how well this approach works within primary care mental health services.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Activation-Guided Self-HelpExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Comparing the effectiveness of behavioral activation in group ...

The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...

Validation of the Effectiveness of a Behavioral Activation ...

The results indicated that the experimental group exhibited significant reductions in depression (Cohen's d = 1.03) and stress (Cohen's d = 0.99) ...

Review Behavioural activation for depression: Efficacy, ...

These forms of psychotherapy are shown to be effective in reducing depressive symptoms, improving quality of life and increasing one's coping skills to prevent ...

Comparison of behavioural activation with guided self-help ...

In the general population, behavioural activation has been shown to be as effective as antidepressant medications, and superior or equivalent to ...

Therapist-guided and self-guided internet-delivered ...

According to a recent meta-analysis of ICBT for adults, therapist-guided ICBT was associated with greater improvement than self-guided treatment.40 However, ...

Efficacy and safety of behavioural activation on depression in ...

Increased suicidal ideation affected 3.7% of the behavioural activation group and 7.4% of the enhanced usual care group. Unexpected physical health-related ...

Guided Self-Help Behavioral Activation Intervention for ... - PMC

This study will focuses on clinical outcomes in terms of reduction of symptom severity and on motivation (behavioral activation or inhibition) ...

Behavioral activation to prevent depression in at-risk ...

This study aimed to assess the feasibility, acceptability, and potential impact of a novel 5-week group Behavioral Activation (BA) prevention program for ...

Validation of the Effectiveness of a Behavioral Activation ...

Recent empirical evidence suggests that behavioral activation therapy is as effective as medication or cognitive behavioral therapy (CBT) in treating depression ...

Behavioral activation interventions for well-being - PMC - NIH

The results revealed that PPIs enhance well-being and ameliorate depressive symptoms, and that these effects are enhanced for individuals with depression.