境界性人格障害における影響ベースの衝動性
境界性人格障害における影響に基づく衝動性：神経計算上の表現型の開発
The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.
Participants will complete online behavioral tasks, a stress induction procedure, self-report surveys, and a cognitive assessment. During the session, psychophysiological measures will be collected, including electrocardiogram (ECG) and cardiac impedance (ICG) to monitor heart rate and blood flow, as well as electrodermal activity (EDA), blood drop samples, and saliva collection to assess nervous system activity.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27514
- University of North Carolina at Chapel Hill
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Borderline Personality Disorder (BPD) group:
- Score of 38 or higher on Personality Assessment Inventory-Borderline Scale (PAI-BOR)
- Participants in the BPD group will be primarily recruited from the two
DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the current study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:
- 3+ BPD symptoms, one of which must be affective instability, per clinical interview
- Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).
Health Control (HC) Group:
- Score of 12 or lower on PAI-BOR
- Score below 50th percentile on World Health Organization Disability Assessment Schedule (WHODAS)
- Absence of any current or lifetime psychiatric disorder, including personality disorders as determined by diagnostic interviews (SIDP and SCID), if the participant had participated in the lab's other studies (IRB Nos. 20-1735 and 21-0602).
Combined Inclusion Criteria:
- Ages 18-45
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to participate in all components of the study
- Participants must be able to speak, understand and read English.
- Participants must have at least 20/40 visual acuity (correct or uncorrected).
Exclusion Criteria:
- Use of as needed antihypertensive agents within 12 hours prior to lab visit
- Inability to refrain from using as needed psychotropic medications for 12 hours prior to lab visit
- History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence
- Family history of Bipolar I disorder in a first degree relative.
- Participants are also excluded for any of the following: cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Stress
Participants will undergo a controlled stress induction approximately 1 hour and 35 minutes into Session 1. |
Participants will complete the Trier Social Stress Test to induce stress, which includes a public speaking simulation and mental arithmetic.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Goal-directed decision-making in the Social Decision Tree Task (SDTT)
時間枠：Collected for 40 minutes ~2 hours into one-time study visit
|
Measured by choice behavior in SDTT, which is based on the decision tree framework. After each action, participants receive feedback about the effect of that action and the extent to which it added to or took away from their points. If participants make a given choice, the subsequent actions that they can choose are different than if they were to initially make a different choice. An action in SDTT is goal-directed if the possible net gain an individual can earn before the end of the current epoch (a "day" in the SDTT) is equal to or higher than the amount they could gain by choosing the alternative action. The investigators will subset trials so that 1 is coded as choosing the immediately valuable action at the expense of the optimal and 0 is coded as choosing the optimal at the expense of the immediately valuable action. This outcome variable is binary. |
Collected for 40 minutes ~2 hours into one-time study visit
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bias toward social actions in the Social Decision Tree Task (SDTT)
時間枠：Collected for 40 minutes ~2 hours into one-time study visit
|
Measured by choice behavior in SDTT, which is based on the decision tree framework. An action in SDTT is defined as social if it is paired with a visual cue with a face on it and non-social if not. This outcome variable is binary. |
Collected for 40 minutes ~2 hours into one-time study visit
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in salivary cortisol
時間枠：Collected shortly after the participant consents into the study (~20 minutes into the one-time study visit) and 20 minutes after stress induction concludes (~2 hours into one-time study visit)
|
The investigators will collect a saliva sample to measure baseline salivary cortisol at the beginning of the session. They will collect a second saliva sample 10 minutes after the stress induction concludes. They will measure cortisol levels in both samples through an assay. The investigators will calculate the change in salivary cortisol by subtracting the measured cortisol in the first saliva sample (collected at baseline) from the measured cortisol in the second saliva sample (collected 10 minutes after the stress induction). Salivary cortisol is measured as nmol/L. Salivary cortisol expected to generally be below 200 nmol/L. |
Collected shortly after the participant consents into the study (~20 minutes into the one-time study visit) and 20 minutes after stress induction concludes (~2 hours into one-time study visit)
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Keely Muscatell, PhD、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- 24-3120
- CTSC0406 (その他の助成金/資金番号：The North Carolina Translational and Clinical Sciences (TraCS) Institute)
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
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
IPD 共有時間枠
Beginning 9 and continuing for 36 months following publication
IPD 共有アクセス基準
Investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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。