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临床试验/NCT00298792
NCT00298792已完成1 期

Individualized Treatment Program for Alcohol Problems

National Institute on Alcohol Abuse and Alcoholism (NIAAA)1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2006年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Alcohol consumption

研究概览

简要总结

The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments.

详细描述

Despite the popularity of Cognitive-Behavioral Treatment (CBT) in substance use disorders, recent findings have indicated that CBT may be no more effective than other, less theoretically driven, treatments, and that CBT treatments often fail to result in coping skills acquisition. In order to explore the possibility that current manual-driven modes of CBT delivery may not be adequate to successfully teach coping skills, we are proposing a pilot project for the development of an individualized assessment and cognitive-behavioral treatment program (IATP) for alcohol-dependent persons, in which experience sampling conducted via random calls to cell-phones is used to provide data to create individualized treatment plans. Data collected during experience sampling will include momentary assessments of patients' cognitions, affects, and coping behaviors with respect to drinking.

Participants will be 112 men and women meeting criteria for alcohol dependence, who will be randomly assigned to either a standard packaged manual-driven cognitive-behavioral treatment program (PCBT) like that used in Project MATCH, or to IATP. Patients in both treatments will be asked to engage in experience sampling for two weeks prior to treatment, and for another two weeks after treatment has ended, in order to compare in-vivo measures of coping skills utilization, pre- and posttreatment, between the two groups. Therapy will be conducted over 12 sessions in both treatments. In IATP, the information gathered from experience sampling will form the basis of a functional analysis of patients' drinking and drinking urges during the monitoring period. Cognitive appraisals, moods and coping responses will be evaluated as antecedents and consequences of drinking behavior. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will work with the patient to substitute adaptive coping tactics instead. In PCBT the experience sampling data will not be specifically used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP will yield significantly better coping skills acquisition than will PCBT, and that change in coping skills will predict better posttreatment outcomes for IATP. These results would have implications for our delivery of treatment, and for the validity of coping skills training for alcohol addiction.

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
None

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

  • •Male and female outpatients 18 years of age or older.
  • •Participants will have a current DSM-IV diagnosis of alcohol dependence.
  • •Participants will have signed a witnessed informed consent.

排除标准

  • •Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
  • •Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.

研究组 & 干预措施

Packaged Cognitive-Behavioral Treatment

Active Comparator

Manualized cognitive-behavioral treatment for alcohol dependent persons.

干预措施: Cognitive-behavioral treatment (Behavioral)

Individualized Assessment & treatment

Experimental

Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.

干预措施: Cognitive Behavioral Treatment (Behavioral)

Individualized Assessment & treatment

Experimental

Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.

干预措施: Cognitive-behavioral treatment (Behavioral)

Packaged Cognitive-Behavioral Treatment

Active Comparator

Manualized cognitive-behavioral treatment for alcohol dependent persons.

干预措施: Cognitive Behavioral Treatment (Behavioral)

结局指标

主要结局

Alcohol consumption

时间窗: Pre - Post

次要结局

  • Alcohol-related life problems(Pre - Post)

研究者

发起方
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
申办方类型
Nih

研究点 (1)

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