Neurocomputational Dynamics of Cooperation (COBRA)
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Michelle M Berry, MPS
- 電話番号:424-380-1194
- メール:berrymic@pitt.edu
研究連絡先のバックアップ
- 名前:Amanda Collier, BS
- 電話番号:412-901-2938
- メール:collieral@upmc.edu
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh, Bellefield Towers
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コンタクト:
- Michelle M Berry, MPS
- 電話番号:424-380-1194
- メール:berrymic@pitt.edu
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コンタクト:
- Amanda Collier, BS
- 電話番号:412-901-2938
- メール:collieral@upmc.edu
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主任研究者:
- Timothy A Allen, PhD
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副調査官:
- Alexandre Dombrovski, MD
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参加基準
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
説明
Online cohort inclusion criteria:
- English fluency
- US residency
- Owner of a desktop or laptop computer
- Adult aged 18-100
Online cohort exclusion criteria:
- Participants who have participated in an earlier version of the study
- Inability to consent
- Self-reported history of neurological disorder or brain damage
- Self-endorsed history of psychosis or mania
Clinical cohort inclusion criteria:
- Adult aged 20-60 years old
- English fluency
- Owner of a smartphone with celluar data
Clinical cohort exclusion criteria:
- Inability to consent
- Self-reported history of neurological disorder or brain damage
- Clinician-rated psychosis or mania in the last 6 months
- Current intoxication or withdrawal
- Estimated IQ < 70
- fMRI safety concerns
- Pregnancy
- Lack of stable psychiatric treatment (e.g., medication dosage, therapy modality) for the previous two months
Informant inclusion criteria:
- Adult aged 18+ years old
- English fluency
- Owner of a smartphone with celluar data
- Must have 4+ interactions/week with the participant for at least 6 months prior to study baseline
Informant exclusion criteria:
- Lack of a smartphone with cellular data at study baseline
研究計画
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:基礎科学
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Online Cohort
The online cohort will include 718 adults ages 18-100 who will complete 1) a battery of behavioral tasks designed to assess social learning and mentalizing abilities, and 2) self-report measures assessing personality, externalizing symptoms, interpersonal functioning, and psychopathology.
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In the primary study task, participants engage in a modified iterative trust game.
Participant choices earn feedback in the form of monetary gains or losses.
All participants are debriefed on the motivation behind study task at the end of their visit.
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実験的:Clinical Cohort
The study will enroll up to 416 clinical-cohort participants, with an anticipated final eligible sample of 239 adults ages 20-60 who will complete 1) a structured clinical interview and neuropsychological assessments, 2) self-report measures assessing personality, externalizing symptoms, interpersonal functioning, and psychopathology, 3) lab-based tasks designed to assess social learning and mentalizing abilities while monitoring physiological responding with Biopac, 4) task-based fMRI, 5) 21-day ecological momentary assessment (EMA) protocol, and 6) additional self-report questionnaires at three yearly follow-ups.
The investigators expect to enroll 416 participants for the start of the protocol to yield 239 final eligible participants to complete fMRI and EMA.
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In the primary study task, participants engage in a modified iterative trust game.
The task is completed in the fMRI scanner and takes about 35 minutes.
Participant choices earn feedback in the form of monetary gains or losses.
All participants are debriefed on the motivation behind the task at the end of their visit.
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介入なし:Informants
Additionally, 2 informants (ages 18+) for each participant will be recruited to complete self-report measures, one of whom will also enroll in EMA.
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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 |
|---|---|---|
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Participant-level Coaxing Score
時間枠:During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)
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Participant coaxing behavior will be measured during the primary social learning task.
Coaxing will be operationalized as the difference in the participant's return rate between exchange and secrecy modes on trials in which the coplayer decides not to share.
In exchange mode, the participant knows whether the coplayer chose to share or keep the monetary incentive before indicating whether they would return it.
In secrecy mode, the participant must make the return decision before learning the coplayer's choice.
The coaxing score is calculated as the exchange-mode return rate minus the secrecy-mode return rate.
Scores range from -1 to 1, with positive values indicating greater strategic coaxing and 0 indicating no difference between modes.
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During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mean Informant-rated Momentary Manipulativeness
時間枠:Post-baseline 21-day EMA period within year 1 of the study
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Manipulativeness will be assessed using the study-specific Interpersonal Dynamics EMA Battery.
The informant-rated manipulativeness scale contains 3 items, each rated from 1 ("strongly disagree") to 5 ("strongly agree").
At each assessment, responses to the 3 items will be averaged to produce a momentary manipulativeness score that ranges from 1 to 5. Higher scores indicate greater informant-rated manipulativeness.
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Post-baseline 21-day EMA period within year 1 of the study
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Latent Mentalizing Factor
時間枠:Baseline
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A latent mentalizing factor will be derived using CFA, with participants' scores on three social cognition tasks serving as indicators.
The latent factor will be standardized to a mean of 0 and standard deviation of 1 in the study sample and therefore has no fixed theoretical minimum or maximum.
Higher factor scores indicate greater mentalizing ability.
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Baseline
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Interpersonal Stress
時間枠:At 12, 24, and 36 months after baseline
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Interpersonal stress will be assessed using the marital- or partner-relationship and other-relationship life domains of the Stress and Adversity Inventory for Adults.
At each follow-up, the frequency scores for stressors in these two domains will be averaged to produce an interpersonal stress score.
The score ranges from a minimum of 0 stressors, with no limit on reported stressor maximums.
Higher scores indicate more frequent exposure to interpersonal relationship stressors.
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At 12, 24, and 36 months after baseline
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Timothy A Allen, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY25050217
- R01MH140901 (米国 NIH グラント/契約)
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?
IPD プランの説明
Individual participant data (IPD) will be shared via the National Institute of Mental Health Data Archive (NDA) in accordance with National Institutes of Health (NIH) Data Management and Sharing Policy. Data will be de-identified and made available to qualified researchers upon request after publication of primary results or completion of the study, as outlined in the NIH-approved Data Sharing Plan.
Task code will be posted on GitHub and/or OSF.
IPD 共有時間枠
All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
IPD and supporting information will be available when the award ends (anticipated 06/30/2031). NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
IPD 共有アクセス基準
Deidentified data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.
To request access to the data, qualified researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。