Clinical and Neurocomputational Effects of Behavioral Activation in Veterans With Impaired Social Functioning

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07697001
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Social Anhedonia
  • Social Function Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Activation (BA) — BEHAVIORAL
    BA is a structured behavioral protocol for depression, designed to help individuals increase engagement in meaningful and rewarding activities, thereby breaking the cycle of avoidance and inactivity that often accompanies depression. The protocol teaches patients to increase a) engagement in pleasant, reinforcing activities, with a strong emphasis on social engagement and social connection, b) exploration of values, and c) goal-setting and goal-directed behavior, while monitoring their mood and daily activities
  • Supportive Care Therapy (SCT) — BEHAVIORAL
    SCT is a Rogerian non-directive approach and employs techniques to convey a deep understanding of emotions, thoughts, and behaviors of the Veterans receiving this treatment. Specific techniques include content-focused paraphrasing, exploration through open-ended questions (with a goal of empathic understanding), and emotion-focused reflection and validation. Consistent with the SCT model, the therapist will be explicitly instructed not to provide advice, assign activities, or suggest strategies and techniques employed in the BA intervention.

Study Details

Poor psychosocial functioning, including social disconnection, is common and disabling among Veterans, and often fails to improve following the best available evidence-based treatments, particularly if more severe pathology is present. Behavioral activation (BA) is a promising, low-burden intervention, which could help improve social functioning impairments in Veterans, as this treatment targets social reward sensitivity, an important driving mechanism of social functioning. Thus, the proposed research will test whether BA can specifically improve social functioning in Veterans. Leveraging a neurocomputational framework of social reward seeking behavior, this research will help to improve the treatment and assessment of social function and the prediction of psychosocial treatment needs in Veterans, while providing neurobehavioral targets to develop new interventions that can restore social functioning.

Key Dates

First listed
Jul 10, 2026
Start date
Jan 1, 2027
Status verified
Jul 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Behavioral Activation (BA)
    This arm provides the experimental treatment, i.e., Behavioral Activation therapy.
  • Active Comparator: Supportive Care Therapy (SCT)
    This arm provides the active control treatment, i.e., Supportive Care Therapy.

Primary Outcome Measure

Social Connectedness Scale - Revised (SCS-R) [ Time Frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Niloofar Afari, PhD
858-642-3657
Katia Harle, MD (PRINCIPAL_INVESTIGATOR)

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