Behavioral Activation for Social Dysfunction

KH
NA
Overseen ByNiloofar Afari, PhD
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 aims to determine if Behavioral Activation (BA) therapy can improve social connections for Veterans experiencing isolation. BA is a simple and promising therapy that may enhance social interactions by increasing the sense of reward from social activities. The trial compares BA therapy to Supportive Care Therapy to identify which is more effective. Veterans who feel socially disconnected and struggle with social interactions might be suitable candidates for this study. As an unphased trial, it offers Veterans an opportunity to explore new ways to enhance their social well-being.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Activation (BA) therapy is generally easy for people to handle. Studies have found that BA can greatly improve mental health and social interactions, with few negative effects reported. For instance, one study revealed that participants experienced fewer symptoms of depression and increased social activity after BA therapy. This suggests that BA is safe, as it typically doesn't cause serious side effects. Additionally, compared to antidepressant medications, BA has proven to be just as effective but with fewer side effects. Overall, research supports that BA therapy is safe and enhances social and mental health.12345

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation (BA) for social dysfunction because it offers a fresh approach by focusing on increasing engagement in positive activities to improve mood and social interactions. Unlike traditional therapies that may focus heavily on analyzing thoughts or past experiences, BA directly targets behavior patterns, which can lead to quicker, tangible improvements in daily life. This proactive method helps individuals develop skills to engage more fully with their environment, potentially making it more effective for those struggling with social withdrawal or isolation.

What evidence suggests that Behavioral Activation might be an effective treatment for social dysfunction?

Research has shown that Behavioral Activation (BA), which participants in this trial may receive, can help improve social skills. A review of studies found that seven out of eight reported improved social feelings and functioning after BA treatment. Another study found that BA was highly effective, reducing social and work-related problems by over 93%. BA increases awareness of social rewards, helping individuals find more joy and connection in social activities. This makes BA a promising option for those facing social challenges, especially Veterans who may experience these issues.13678

Who Is on the Research Team?

KH

Katia Harle, MD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans who have trouble enjoying or participating in social activities, such as those with social anhedonia or difficulty adjusting socially. Participants should not have conditions that would prevent them from taking part safely.

Inclusion Criteria

Being a Veteran
Having moderate to high levels of social disconnection (Social Connectedness Scale-Revised/SCS-R score < 90)
Having moderate to high levels of social functioning impairments (Sheehan Disability Scale/SDS-social domain score >= 5)
See 1 more

Exclusion Criteria

Suicidal or homicidal ideation within the past month necessitating urgent higher-level care
Lifetime history of psychotic or bipolar disorder
Current severe alcohol or substance use disorders necessitating prioritization of substance use treatment
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 (BA) or Supportive Care Therapy (SCT) over 12 weeks

12 weeks
Weekly therapy sessions via telehealth

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Assessments at 12-weeks post-treatment

Neurocomputational Assessment

Participants complete a computerized task to probe social reward-seeking behavior, with concurrent fMRI in a subset

Baseline and post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation (BA)

Trial Overview

The study compares two types of talk therapy: Behavioral Activation (BA), which encourages engaging in rewarding activities to improve mood and social life, and Supportive Care Therapy (SCT), which offers general emotional support. Participants are randomly assigned to one group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Activation (BA)Experimental Treatment1 Intervention
Group II: Supportive Care Therapy (SCT)Active 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

The effectiveness of behavioral activation therapy on ... - PMC

Finally, the reduction of behavioral activation therapy on occupational-social functioning impairment was 93.5% in the post-test and 93.7% in ...

Behavioral activation for social connection: A systematic ...

Seven of eight studies reported significant improvements in social connection outcomes, with effects most pronounced for subjective/functional ...

A Narrative Review of Empirical Literature of Behavioral ...

This review aims to present a conceptual overview of the BA followed by reviewing empirical evidences supporting its efficacy for treatment of depression.

Behavioral Activation for Social Connectedness

This trial aims to help older adults feel more socially connected through a six-session program called Brief Behavioral Activation, a type of therapy.

Behavioural activation for depression: Efficacy, ...

Based on the research literature, it can be concluded that behavioural activation could be a viable option as a low-intensity guided self-help psychological ...

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 ...

The efficacy of behavioural activation treatment for co ...

an increased risk of post-traumatic stress disorder, higher risk of suicidal behaviours, and an increased risk of relapse in substance use ...

Behavioral activation for children and adolescents - PMC - NIH

The RCTs reported largely positive outcomes. Meta-analysis of depression scores indicated that BA may be effective; however, high heterogeneity ...