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

8. Juli 2026 aktualisiert von: VA Office of Research and Development
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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

136

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • California
      • San Diego, California, Vereinigte Staaten, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Kontakt:
        • Hauptermittler:
          • Katia Harle, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Behavioral Activation (BA)
This arm provides the experimental treatment, i.e., Behavioral Activation therapy.
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
Aktiver Komparator: Supportive Care Therapy (SCT)
This arm provides the active control treatment, i.e., Supportive Care Therapy.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Social Connectedness Scale - Revised (SCS-R)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Primary Psychiatric Diagnosis
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reaction to Treatment Questionnaire
Zeitfenster: Baseline, Post-Treatment (12-weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)
Zeitfenster: Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)
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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Katia Harle, MD, VA San Diego Healthcare System, San Diego, CA

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

IPD and supporting information will become available upon completion of the study and publication of the the results.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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