Clinical and Neurocomputational Effects of Behavioral Activation in Veterans With Impaired Social Functioning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Activation (BA), Supportive Care Therapy (SCT).
- Who it may be relevant to
- Registry conditions: Social Anhedonia, Social Function Impairment. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 - 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
Primary outcome measures
- Social Connectedness Scale - Revised (SCS-R) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Inventory of Psychosocial Functioning (IPF) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Specific Loss of Interest and Pleasure Scale (SLIPS) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Social Reward Maximization [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Neural Activation to Social Reward Prediction Errors (RPEs) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
Secondary outcome measures (6)
- Primary Psychiatric Diagnosis [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- World Health Organization Quality of Life Scale (WHOQOL-BREF) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- PTSD Checklist-5 (PCL-5) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Beck Anxiety Inventory (BAI) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
- Snaith-Hamilton Pleasure Scale (SHAPS) [Time frame: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA San Diego Healthcare System, San Diego, CA — San Diego
Identifiers
NCT: NCT07697001 · RRD4-009-25W