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临床试验/NCT02527720
NCT02527720已完成不适用

Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking

University of Maryland, College Park1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015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
10
试验地点
1
主要终点
Changes in substance use utilizing the Timeline Follow Back from the baseline to 3 months

研究概览

简要总结

The investigators plan to establish the efficacy of a novel breathing-based mindfulness training (BBMT, a much simplified, easy-to-use version of standard MM) for problem drinking, and test whether impulsivity mediates this effect among a sample of student problem drinkers (i.e., > 8 on AUDIT, the problem drinking Screening Test). The specific aims of this pilot study are as follows:

  1. to modify and further develop the easy-to-use BBMT program for directly targeting impulsivity to produce an indirect reduction in problem drinking among college students;
  2. to investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT);
  3. to examine changes in impulsivity, as measured by both behavioral and self-report assessments, as one of the possible mediators in the effect of BBMT on problem drinking, with control for changes in perceived stress and anxiety.

详细描述

An efficacious strategy for addressing problem substance use among college student drinkers is to target core risk factors. Arguably one of the most clearly documented risk factors for problem drinking among college students is impulsivity, with the relationship holding across various dimensions of impulsivity. Available evidence supports the importance of intervening with impulsivity to limit problem drinking among college students, but there are few proven treatments for any dimension of impulsivity. This notable lack may be due to the traditional view of impulsivity as an unchangeable personality trait. However, recent research suggests personality can change and is sensitive to behavior manipulation. As a result there is clear need for novel approaches targeted at core changes in the individual and their behavior patterns. Mindfulness meditation (MM) is a unique option in this direction as MM is especially useful in reducing impulsive behaviors including problem drinking, but its exact role in affecting different dimensions of impulsivity and in effecting change in problem drinking has yet to be explored. Based on evidence from recent studies, as well as our own pilot work, the investigators hypothesize that one of the mechanisms by which MM reduces problem drinking among college students is by lessening impulsivity - moreover, the focus on changing college student problem drinking is done without any explicit focus on drinking behavior itself. The specific aims of this Stage 1 therapy development study are to: 1) modify and further develop a breathing-based mindfulness therapy (BBMT) for reducing impulsivity and problem drinking among college youth; 2) investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT); 3) examine changes in impulsivity, as measured by both behavioral and self-report assessments, as one of possible mediators in the observed effect of BBMT on problem drinking. These aims will be achieved in two phases. In Phase 1 the investigators will expand and fully develop the existing BBMT program with manuals to determine the effective treatment dosage for both problem drinking and impulsivity in an open label trial (n = 10). Using the modified treatment materials from Phase 1, in Phase 2 the investigators will conduct a RCT comparing the effects of modified BBMT to a Supportive Counseling + Progressive Muscle Relaxation (SC + PMR) control condition (n = 36 each) on problem drinking, assessed at baseline, weeks 4 and 8, and a 3-month follow-up. Other potential mediators such as perceived stress and anxiety also will be examined in the final model. This study has great potential implications for reaching college students drinkers less willing to acknowledge their drinking problems as it addresses a core vulnerability (impulsivity) among at-risk students in a manner that limits stigma and may reduce resistance to change. A diverse team experienced in mindfulness, impulsivity and behavior therapy development has been assembled to conduct the proposed R34 project and prepare for a full therapy development study in the future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •UM College Park students aged 18-30
  • •AUDIT score of 8 or higher (Babor et al., 2004)
  • •A total score on the Barratt Impulsiveness Scale of 73 or higher, which is the mean plus half (1/2) standard deviation, (M=64; SD=17) (Patton et al., 1995)
  • •A commitment to adhere to the study protocol with a weekly therapy meeting (about 40 minutes each), and an extra 1.5 to 2 hours for study data collection at week 4 and week 8
  • •No plan to move away from the UM campus area for next 2 months

排除标准

  • •At current risk of suicide, including suicidal behavior or attempts in the past 30 days
  • •A history of schizophrenia or other psychotic disorders
  • •Current participation in other clinical studies of addiction or impulsive behavior
  • •Severe physical and mental health problems

研究组 & 干预措施

Mindfulness Therapy

Experimental

For the current study the investigators have developed a breathing-based, adapted for feasible application among SUD populations, and easy to carry out in clinical or non-clinical settings referred to as breathing-based mindfulness training (BBMT). BBMT is a simplified form of MM. Its core components are near resonance-frequency breathing (RFB), mindfulness training, positivity and inward attention (more details below).

干预措施: Mindfulness Therapy (Behavioral)

结局指标

主要结局

Changes in substance use utilizing the Timeline Follow Back from the baseline to 3 months

时间窗: Weeks 1-8 and 3 month follow up

Timeline Follow-back (TLFB) (C. Sobell \& B. Sobell, 1992) will be used to record and track participants' recent (past 30 days and 7 days) alcohol-use as well as other drug use frequency. Alcohol-use and other drug use quantity will be recorded for each day on which use was reported. The TLFB method has been shown to have good reliability and validity in college students (Sobell et al., 1989)

次要结局

  • Spielberger State-Trait Anxiety Inventory (STAI):(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Customary Drinking and Drug Use Record(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Barratt Impulsiveness Scale(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Stop-Signal Task (SST)(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • RFB or MM Feedback and Quality Assessment(Weeks 1-8 and 3 month follow up)
  • Audit(Baseline)
  • Readiness to Change(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Delay Discounting of Hypothetical Money Gains(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • The Center for Epidemiological Studies Depression Scale (CES-D)(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Five-Facet Mindfulness Questionnaire(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • The Program Evaluation Form(Week 4, Week 8, and 3 month Follow Up)
  • UPPS Impulsive Behavioral Scale(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Perceived Stress Scale(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Therapist adherence and competence(Week 4, Week 8, and 3 month Follow Up)
  • Working Alliance Inventory (WAI)(Week 4, Week 8)
  • Perceived Quality of Life Measure(Baseline , Week 4 , Week 8, and 3 month Follow Up)
  • Treatment Progress/Completion(Week 8)

研究者

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

Carl W. Lejuez

Professor

University of Maryland, College Park

研究点 (1)

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