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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Social Anhedonia; Social Function Impairment
• Intervention / Treatment: Behavioral: Behavioral Activation (BA); Behavioral: Supportive Care Therapy (SCT)

Detailed Description

Perceived social disconnection and social isolation are disabling and common among Veterans. Yet, these psychosocial impairments can fail to improve following the best available evidence-based treatments. Behavioral activation (BA), an evidence-based treatment for depression has shown promise in improving social functioning. However, most of this research was conducted in primarily non-Veteran populations and has typically relied on patients' subjective symptoms and self-report, in contrast to objective behavioral probes, to assess social functioning. Moreover, the cognitive mechanisms promoting social behavior remain poorly understood, particularly in Veterans. For instance, social anhedonia, i.e., a reduced sensitivity to social rewards, such as positive human interactions, has been implicated as an important driving mechanism of poor social functioning. Yet, the degree to which BA successfully target social reward sensitivity remains unclear and has not been evaluated in Veterans. This lack of understanding limits the ability to develop more targeted and effective interventions for psychosocial recovery. To address these gaps, this study aims to test the clinical and neurobehavioral effectiveness of BA in targeting social dysfunction in Veterans.

Computational models of reward learning (RL), particularly Bayesian RL learning models, can offer an important bridge to link in-vivo behavior, such as social reward sensitivity, and recovery outcomes like psychosocial functioning, by providing a rich quantitative representation of reward learning and its dynamic updating during reward exploration. This proposal aims to capitalize on this approach, combining a translational behavioral paradigm, Bayesian reinforcement learning modeling, and neuroscientific evaluation of change processes, in order to assay social anhedonia and improve prediction of social functioning as well as understanding and effective dissemination of BA treatment.

The specific aims are to: 1) test the effectiveness of BA in improving social functioning outcomes in Veterans (Aim 1); 2) examine the impact of BA on neurocomputational markers of social reward sensitivity and their relationship to social functioning improvement in Veterans (Aim 2); and 3) assess the degree to which neurocomputational markers of social reward sensitivity predict social functioning recovery in Veterans undergoing BA (Aim 3). This project will also explore whether the relationships between neurocomputational markers of social function and clinical outcomes are moderated by primary diagnosis (exploratory Aim 4).

Veterans (N=136) with impaired social functioning and anhedonia will be recruited and randomized to either behavioral activation (BA) or supportive care therapy (SCT; active control) over 12 weeks. At baseline, immediately post-treatment, and 12-weeks post-treatment (24-weeks follow-up), participants will complete a computerized task aimed at probing social reward-seeking behavior, in which they must choose between unknown partners with the goal of maximizing the number of compliments they receive from these partners. Concurrent brain activity will be collected with functional magnetic resonance imaging (fMRI) in a subset of participants (N=68; at baseline and post-treatment). Therapy sessions and follow-up (24-weeks) assessments will be administered through VA-approved telehealth methods. Computational modeling will be used to derive individual parameters of social reward (i.e., compliments) learning and maximization, and to extract associated neural activity, e.g., neural responses to prediction error signals (discrepancies between expected and actually obtained reward/compliment). Randomization of participants to treatment arms will be be stratified based on fMRI eligibility status, sex, and primary psychiatric diagnosis.

This project is expected to 1) determine if BA offers an effective, low-burden option to improve social functioning in Veterans; 2) identify potential neurocognitive targets, which could be used in future research to develop and test novel treatments to improve psychosocial functioning in Veterans, such as computerized neurocomputational training protocols to boost social reward sensitivity; and 3) help identify precise markers of BA responsiveness for functional recovery.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Niloofar Afari, PhD; Phone Number: (858) 642-3657; Email: Niloofar.Afari@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA
      • Contact: Niloofar Afari, PhD; Phone Number: 858-642-3657; Email: Niloofar.Afari@va.gov
      • Principal Investigator: Katia Harle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)
• having moderate to high levels of social anhedonia (Specific Loss of Interest and Pleasure Scale/SLIPS score >= 6)

Exclusion Criteria:

• lifetime history of psychotic or bipolar disorder
• neurological conditions, neurodevelopmental disorders, or sensory deficits that may impact cognitive functioning to preclude understanding/completion of study procedure
• regular use of certain psychotropic medications that may significantly impact goal-directed performance on the task (i.e., benzodiazepines, sedative hypnotics, and opioid analgesics); pre-existing stable doses of psychotropic medications, such as SSRIs, will be allowed (if same regimen has been taken for at least 30 days)
• current severe alcohol or substance use disorders (AUD/SUD) necessitating prioritization of substance use treatment
• suicidal or homicidal ideation within the past month necessitating urgent higher-level care
• concurrent individual cognitive-behavioral psychotherapy specifically targeting depression, anhedonia, and/or PTSD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation (BA); This arm provides the experimental treatment, i.e., Behavioral Activation therapy.	Behavioral: Behavioral Activation (BA); 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
Active Comparator: Supportive Care Therapy (SCT); This arm provides the active control treatment, i.e., Supportive Care Therapy.	Behavioral: Supportive Care Therapy (SCT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Connectedness Scale - Revised (SCS-R)	Measures the degree to which individuals feel connected to others in their social environment. Scores range from 20 to 120, where higher scores indicate a stronger, healthier sense of social connectedness.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Inventory of Psychosocial Functioning (IPF)	The scale measures the degree of impairment in ability to interact effectively with others, fulfill social roles (e.g., work), and meet personal and societal expectations. It is comprised of 7 subscales. Each item ranges from 0 to 6. Higher scores indicate greater degree of impairment in psychosocial functioning.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Specific Loss of Interest and Pleasure Scale (SLIPS)	This is a measure of social anhedonia, i.e., hypo-responsiveness to social rewards, such as positive human interactions. Scores range from 0 to 69. Higher scores indicate greater severity of social anhedonia.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Social Reward Maximization	Computational parameter derived from behavioral social functioning probe (behavioral reinforcement learning task), capturing the degree to which individuals select social partners they predict to be more rewarding (to offer the most compliments).	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Neural Activation to Social Reward Prediction Errors (RPEs)	Average BOLD (Blood-Oxygenation-Level Dependent) % signal change (i.e., activation) associated with individuals' model-based RPE (difference between expected probability of reward/compliment and actual outcome received. i.e., compliment vs no-compliment).	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Psychiatric Diagnosis	Primary diagnostic category (i.e., depressive vs traumatic stress/anxiety disorder)	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
World Health Organization Quality of Life Scale (WHOQOL-BREF)	Measures quality of life and life satisfaction. Includes 4 domain subscales: physical health (range 7-35), psychological health (range 6-30), social relationships (range 3-15), and environment (range 8-42). Higher scores indicate higher quality of life.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Patient Health Questionnaire-9 (PHQ-9)	Measures depression severity. Scores range from 0 to 27. Higher scores indicate greater depression severity.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
PTSD Checklist-5 (PCL-5)	Measures post-traumatic stress disorder (PTSD) severity. Scores range from 0 to 80, with higher scores indicating greater PTSD severity.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Beck Anxiety Inventory (BAI)	This scale measures anxiety severity. Scores range from 0 to 63, with higher scores indicating greater anxiety severity.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Snaith-Hamilton Pleasure Scale (SHAPS)	Measure of anhedonia. Score range from 14 to 56, with higher scores indicating greater anhedonia severity.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction to Treatment Questionnaire	Measure of treatment satisfaction and credibility of treatment rationale. Total scores range from 3 to 27, with higher scores indicating greater satisfaction and credibility in the treatment.	Baseline, Post-Treatment (12-weeks)
Mood and Anxiety Symptoms Questionnaire (MASQ-D30)	Measure of anhedonic depression, anxiety, and stress symptoms. The scale has three subscales (general distress, anhedonic depression, and anxious arousal) , with each score ranging from 10 to 50. Higher scores indicate greater severity of symptoms.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
Liebowitz Social Anxiety Scale (LSAS)	Assesses the impact of social anxiety on multiple aspects of life. Scores range from 0 to 144, with higher scores indicating greater social anxiety.	Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Katia Harle, MD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Social Functioning; Anhedonia; Reinforcement Learning; Social Reward
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Anhedonia; Social Adjustment; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: RRD4-009-25W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study as well as statistical code, and therefore these will be sufficient to reproduce or verify any published findings.

Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.

• IPD Sharing Time Frame: IPD and supporting information will become available upon completion of the study and publication of the the results.
• IPD Sharing Access Criteria: Final de-identified datasets in machine-readable format will be submitted to and accessed from PubMed Central (and similar sites); care will be taken to ensure that individuals cannot be re-identified using other publicly available information.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No