이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 7월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

136

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • California
      • San Diego, California, 미국, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • 수석 연구원:
          • Katia Harle, MD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Behavioral Activation (BA)
This arm provides the experimental treatment, i.e., Behavioral Activation therapy.
행동: 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
활성 비교기: Supportive Care Therapy (SCT)
This arm provides the active control treatment, i.e., Supportive Care Therapy.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Social Connectedness Scale - Revised (SCS-R)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Primary Psychiatric Diagnosis
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Reaction to Treatment Questionnaire
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VA Office of Research and Development

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 29일

QC 기준을 충족하는 최초 제출

2026년 7월 8일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 14일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RRD4-009-25W

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다