Computerized Intervention for Distress Intolerance
2019年11月20日 更新者:Richard Macatee、Auburn University
This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.
調査の概要
状態
完了
条件
詳細な説明
Distress intolerant cannabis users were randomized to a computerized distress intolerance intervention or a control intervention.
Primary and secondary outcomes consist of the treatment target, cannabis use-related behavior, and theoretically-relevant neurophysiological processes (i.e., cannabis cue reactivity, response inhibition).
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
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
18年~30年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Distress Intolerance Index score >= 20
- Average cannabis use frequency in the past year >= 2-3/week
Exclusion Criteria:
- Current suicidal ideation
- History of psychotic symptoms
- Bipolar-spectrum disorder without stabilization on medication for >= 3 months
- Change in psychotropic medication in the past month
- Current CBT for internalizing or substance use disorders
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 |
|---|---|
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実験的:Computerized Distress Intolerance Intervention
Two, 1-hour computerized sessions that include psychoeducation about emotional avoidance, idiographic emotional exposure, and construction of idiographic implementation intentions to practice distress tolerance skills outside of session.
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プラセボコンパレーター:Computerized Healthy Behaviors Intervention
Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.
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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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Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Self-report measure of Distress Intolerance (Distress Intolerance Index [DII]; McHugh & Otto, 2012).
The DII is a self-report measure comprised of 10 items that are summed together to form a total score (minimum: 0; maximum: 40).
Higher scores indicate greater distress intolerance (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Behavioral measure of Distress Intolerance (Mirror-Tracing Persistence Task [MTPT]; Macatee & Cougle, 2015).
The MTPT is a behavioral persistence measure that assesses behavioral distress intolerance via the latency to quit a distressing task.
Scores range from 0 seconds to a maximum persistence time of 7 minutes.
Lower scores indicate greater distress intolerance (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in Marijuana Problems Scale (MPS) score from Baseline through 4-Month Follow-Up
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Self-report measure of marijuana use-related problems (Marijuana Problems Scale [MPS]; Stephens et al., 2000).
The MPS is a self-report measure of marijuana use-related problem severity in the past month.
The measure is comprised of 19 items with a minimum score of 0 and a maximum score of 38.
Higher scores indicate greater marijuana use-related problem severity in the past month (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 4-Month Follow-Up
時間枠:Baseline, 4-month follow-up
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Interviewer-assessed Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Cannabis Use Disorder diagnostic criteria.
DSM-5 Cannabis Use Disorder criteria were assessed via interview at baseline and again at the 4-month follow-up.
Total number of Cannabis Use Disorder criteria was used to assess Cannabis Use Disorder severity (minimum score: 0; maximum score: 11).
Higher scores indicate greater Cannabis Use Disorder severity (i.e., worse outcome).
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Baseline, 4-month follow-up
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Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Percent cannabis use days in the past month (Timeline follow-back [TLFB]; Hjorthoj et al., 2012).
The Timeline follow-back (TLFB) is a self-report measure that assesses cannabis use over the past 4 weeks.
Percentage of days on which cannabis was used in the past four weeks was used to assess cannabis use frequency (minimum: 0%; maximum: 100%).
Higher scores indicate greater cannabis use frequency (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Marijuana Motives Measure (MMM) score from Baseline through 4-Month Follow-Up
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
|
Self-reported motives for cannabis use (Marijuana Motives Measure [MMM]; Zvolensky et al., 2007).
The Marijuana Motives Measure (MMM) is a self-report measure that assesses different motives for marijuana use.
The coping motives subscale was the subscale of interest in this project.
The Coping motives subscale is comprised of 4 items that are then averaged (minimum score: 1; maximum score: 5).
Greater scores indicate greater coping motives for marijuana use (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Self-reported state craving for marijuana (Marijuana Craving Questionnaire [MCQ]; Heishman et al., 2009).
The Marijuana Craving Questionnaire (MCQ) is a self-report measure of current craving for marijuana use.
The emotionality subscale was the subscale of interest in this project.
The Emotionality subscale is comprised of 5 items that are then averaged (minimum score: 1; maximum score: 7).
Greater scores indicate greater marijuana craving (i.e., worse outcome).
In this project, the outcome of interest is the extent to which a laboratory stress induction increases state marijuana craving.
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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 |
|---|---|---|
|
Change in electroencephalography (EEG) index of acute stress modulation of cannabis cue reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session)
|
Acute Stress modulation of the Late Positive Potential (LPP) to Cannabis Cues.
The LPP to visual cannabis cues before and after a laboratory stress induction will be measured as a neurophysiological index of acute stress modulation of cannabis cue incentive salience.
Greater values indicate a larger neural response to cannabis cues during acute stress (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Acute Stress modulation of the Late Positive Potential (LPP) to threat stimuli.
The LPP to visual threat stimuli before and after a laboratory stress induction will be measured as a neurophysiological index of acute stress modulation of threat reactivity.
Greater values indicate a larger neural response to threat during acute stress (i.e., worse outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment
時間枠:Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Acute stress modulation of the N2 to no-go stimuli.
The N2 to no-go vs. go stimuli on a go/no-go task before and after a laboratory stress induction will be measured as a neurophysiological index of the acute stress modulation of response inhibition.
More negative values indicate a larger neural response to stimuli requiring response inhibition during acute stress (i.e., better outcome).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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
捜査官
- 主任研究者:Richard J Macatee, PhD、Auburn University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Stephens RS, Roffman RA, Curtin L. Comparison of extended versus brief treatments for marijuana use. J Consult Clin Psychol. 2000 Oct;68(5):898-908.
- McHugh RK, Otto MW. Refining the measurement of distress intolerance. Behav Ther. 2012 Sep;43(3):641-51. doi: 10.1016/j.beth.2011.12.001. Epub 2011 Dec 20.
- Macatee RJ, Cougle JR. Development and evaluation of a computerized intervention for low distress tolerance and its effect on performance on a neutralization task. J Behav Ther Exp Psychiatry. 2015 Sep;48:33-9. doi: 10.1016/j.jbtep.2015.01.007. Epub 2015 Jan 26.
- Hjorthoj CR, Hjorthoj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26.
- Zvolensky MJ, Vujanovic AA, Bernstein A, Bonn-Miller MO, Marshall EC, Leyro TM. Marijuana use motives: A confirmatory test and evaluation among young adult marijuana users. Addict Behav. 2007 Dec;32(12):3122-30. doi: 10.1016/j.addbeh.2007.06.010. Epub 2007 Jun 9.
- Heishman SJ, Evans RJ, Singleton EG, Levin KH, Copersino ML, Gorelick DA. Reliability and validity of a short form of the Marijuana Craving Questionnaire. Drug Alcohol Depend. 2009 Jun 1;102(1-3):35-40. doi: 10.1016/j.drugalcdep.2008.12.010. Epub 2009 Feb 13.
- Macatee RJ, Preston TJ, Afshar K, Schmidt NB, Cougle JR. Impact of a computerized distress intolerance intervention on electrocortical reactivity to cannabis and threat cues: A randomized controlled trial. Psychol Addict Behav. 2022 Nov;36(7):920-929. doi: 10.1037/adb0000815. Epub 2022 Feb 7.
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 (実際)
2016年6月1日
一次修了 (実際)
2017年10月30日
研究の完了 (実際)
2017年10月30日
試験登録日
最初に提出
2019年11月13日
QC基準を満たした最初の提出物
2019年11月20日
最初の投稿 (実際)
2019年11月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月21日
QC基準を満たした最後の更新が送信されました
2019年11月20日
最終確認日
2019年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 201720828
- F31DA039644-01A1 (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?
いいえ
IPD プランの説明
All individual participant data will be made available upon request once primary and secondary outcome manuscripts have been published.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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