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

2026年7月14日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

136

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • San Diego、California、アメリカ、92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • 主任研究者：
          • Katia Harle, MD
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Behavioral Activation (BA)
This arm provides the experimental treatment, i.e., Behavioral Activation therapy.
行動：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
アクティブコンパレータ：Supportive Care Therapy (SCT)
This arm provides the active control treatment, i.e., Supportive Care Therapy.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Social Connectedness Scale - Revised (SCS-R)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Primary Psychiatric Diagnosis
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

その他の成果指標

結果測定
メジャーの説明
時間枠
Reaction to Treatment Questionnaire
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

VA Office of Research and Development

捜査官

  • 主任研究者：Katia Harle, MD、VA San Diego Healthcare System, San Diego, CA

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2030年12月31日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年6月29日

QC基準を満たした最初の提出物

2026年7月8日

最初の投稿 (実際)

2026年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月16日

QC基準を満たした最後の更新が送信されました

2026年7月14日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RRD4-009-25W

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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