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临床试验/NCT00760994
NCT00760994已完成不适用

Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance

Seattle Institute for Biomedical and Clinical Research1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年1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
80
试验地点
1
主要终点
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)

研究概览

简要总结

The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post-traumatic stress disorder (PTSD) symptoms in individuals who suffer from PTSD.

详细描述

Alcohol dependence (AD) afflicts nearly 14% of the population (Kessler et al., 1994; Kessler et al., 1997; Regier et al., 1990), and has a chronic and relapsing course (Brownell, Marlatt, Litchenstein, & Wilson, 1986). Negative emotional states have consistently been found to maintain alcohol use disorders (AUDs; Cooney, Litt, Morse, Bauer, & Gaupp, 1997; Litt, Cooney, Kadden, & Gaupp, 1990; Rubonis et al., 1994) and increase the risk of relapse following AUD treatment (Cooney et al., 1997). This relationship is particularly robust among individuals with co-morbid psychiatric disorders, such as posttraumatic stress disorder (PTSD; Coffey et al., 2002; Sharkansy, Brief, Peirce, Meehan, & Mannix, 1999; Tate, Brown, Unrod, & Ramo, 2004; Waldrop, Back, Verduin, & Brady, in press). Likewise, alcohol use may be maintained by a desire to facilitate or prolong positive emotional states (Cooper, Frone, Russell, & Mudar, 1992; Simpson, 2003).

Many psychological interventions for AUDs, most notably the majority of cognitive-behavioral treatment (CBT) packages, have thus focused on the development of coping skills to prevent relapse in response to such triggers, and have been demonstrated to be at least moderately effective in promoting abstinence (Miller & Wilbourne, 2002). However, attempts to specify the active ingredients of CBT for AD have been disappointing and most studies examining potential mechanisms of change have failed to find the expected relationships (Longabaugh et al., 2005; Morgenstern & Longabaugh, 2000). The lack of empirical evidence substantiating coping skills as a mechanism of change for CBT (Morgenstern & Longabaugh, 2000) may be due, in part, to the lack of specificity in coping skill interventions. Broadly speaking, two primary foci of coping skill interventions for AUD are 1) increasing cognitive techniques focused on challenging and changing thought patterns, or 2) increasing experiential acceptance by fostering an accepting stance towards internal states, such as through "urge surfing" (Kadden et al., 1992). These two coping skill approaches (cognitive restructuring and experiential acceptance) likely lead to reduced alcohol use through different pathways. Theoretically, experiential acceptance approaches suggest that the mechanism of change in decreasing alcohol use is increased willingness toward internal experience (e.g., emotions, thoughts, sensations), whereas cognitive restructuring approaches suggest that decreased alcohol use results from decreases in negative appraisals brought about by challenging and changing thought patterns. However, this has yet to be systematically evaluated.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •age at least 18 years
  • •current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month
  • •current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)
  • •capacity to provide informed consent
  • •English fluency
  • •no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions
  • •access to a telephone
  • •desire to decrease or stop alcohol drinking behavior

排除标准

  • •a history of delirium tremens
  • •seizures, in order to ensure that participants will be medically safe to decrease alcohol use
  • •opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month
  • •currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)
  • •exhibits signs or symptoms of alcohol withdrawal at the time of initial consent
  • •acutely suicidal with intent/plan or present an imminent danger to others
  • •a current psychotic disorder
  • •For ethical reasons and because of the preliminary nature of this study, participants may be in ongoing substance abuse or mental health treatment (MH) or may initiate counseling or medications (other than those noted in exclusion criteria) during the course of the study. Mental health treatment involvement will be used as a covariate if it is related to study dependent variables.

研究组 & 干预措施

1 - Experiential Accepatance

Experimental

Experiential acceptance

干预措施: Experiential acceptance (Behavioral)

2 - Cognitive Restructuring

Active Comparator

Cognitive restructuring

干预措施: Cognitive restructuring (Behavioral)

3 - Control

Placebo Comparator

No-intervention control: Nutrition information

干预措施: No-intervention control: Nutrition information (Other)

结局指标

主要结局

Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)

时间窗: 5 weeks

After the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.

次要结局

  • Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)(5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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