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临床试验/NCT04173078
NCT04173078已完成不适用

Computerized Intervention for Distress Intolerance

Auburn University0 个研究点目标入组 60 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up

研究概览

简要总结

This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants were blind to whether they were in the experimental (Distress Intolerance Intervention) or control (Healthy Behaviors Intervention) condition. All outcome measures were self-report except for the four-month follow-up Cannabis Use Diagnostic interview which was conducted by an interviewer blind to the participant's treatment condition.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Distress Intolerance Index score >= 20
  • •Average cannabis use frequency in the past year >= 2-3/week

排除标准

  • •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

研究组 & 干预措施

Computerized Distress Intolerance Intervention

Experimental

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.

干预措施: Computerized Distress Intolerance Intervention (Behavioral)

Computerized Healthy Behaviors Intervention

Placebo Comparator

Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.

干预措施: Computerized Healthy Behaviors Intervention (Behavioral)

结局指标

主要结局

Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up

时间窗: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up

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).

Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 4-Month Follow-Up

时间窗: Baseline, 4-month follow-up

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).

Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up

时间窗: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up

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).

Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment

时间窗: Baseline, post-treatment (i.e., ~1 week following the last treatment session)

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).

Change in Marijuana Problems Scale (MPS) score from Baseline through 4-Month Follow-Up

时间窗: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up

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).

Change in Marijuana Motives Measure (MMM) score from Baseline through 4-Month Follow-Up

时间窗: 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).

Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment

时间窗: Baseline, post-treatment (i.e., ~1 week following the last treatment session)

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.

次要结局

  • Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment(Baseline, post-treatment (i.e., ~1 week following the last treatment session))
  • 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(Baseline, post-treatment (i.e., ~1 week following the last treatment session))
  • Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment(Baseline, post-treatment (i.e., ~1 week following the last treatment session))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Macatee

Assistant Professor

Auburn University

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