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临床试验/NCT02298751
NCT02298751已完成不适用

Alcohol Cue Exposure: An Investigator-blinded, Randomized, Controlled Study of Exposure-based Aftercare in Alcohol Use Disorder Individuals

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年5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
160
试验地点
1
主要终点
Alcohol consumption

研究概览

简要总结

Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapse when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aim of this study is to investigate whether CET as aftercare increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals.

Design and methods: The study is implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol outpatient clinic will be randomized to one of the three following aftercare treatment groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100), and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)), and It will be explored whether CET as smartphone application is as effective as CET as group therapy. The groups will be compared in a number of parameters including alcohol intake, cravings and copings-strategies.

Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there appears to be segregation in the empirical literature when it comes to treatment of addictive disorders. However, CET may allow the patient to practice and gain control over alcohol cue reactivity and associated high-risk situations in an inter-mediating therapeutic context before the patients inevitably are confronted by them. In this way, one might expect the transition from treatment to daily life less overwhelming and CET may help prevent relapse in the long term. Thus, CET may be particularly suitable as aftercare.

详细描述

BACKGROUND It is well documented that individuals with Alcohol Use Disorders (AUD) respond well during Cognitive Behavioural Therapy, but that a large proportion of individuals relapse after treatment when confronted with alcohol in real life. Therefore, future treatment interventions for long-term prevention of relapse should aim to teach how to apply coping strategies and regain control over their alcohol cravings in their daily confrontations with alcohol and associated stimuli.

Cue Exposure Treatment (CET) is a behavioural psychological approach that focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. During CET individuals are exposed to alcohol related stimuli whilst their usual drink responses are hindered. Thus, they are given the opportunity to practice coping strategies during exposure to alcohol. In this way, it is predicted that individual's learned automatic responses will extinguish over time and that their cognitive control over cue reactivity strengthens.

Mental health care applications, has the potential to improve alcohol treatment and continuing care by offering psychological treatment anywhere and when the patient find it convenient. Because, psychological treatment is a substantial socio-economic burden when delivered in individual sessions, there has been a tendency to deliver the relevant treatment through group sessions. However, mental healthcare applications, have even more potential in order to reduce the burden on the health care system, in addition to increasing the availability of evidence-based treatment. Whilst group sessions are documented effective, behavioural healthcare applications targeting AUD needs further exploration.

OBJECTIVES

The objective of the study is three-fold:

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 (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Completed primary treatment with CBT
  • •Accept participating in the study

排除标准

  • •Not Danish speaking
  • •Psychotic disorders
  • •Severe cognitive impairment
  • •Terminal somatic illness

研究组 & 干预措施

CET via smartphone

Experimental

Cue Exposure Treatment

干预措施: Cue Exposure Treatment (Behavioral)

CET via group sessions

Experimental

Cue Exposure Treatment

干预措施: Cue Exposure Treatment (Behavioral)

Aftercare as usual

No Intervention

结局指标

主要结局

Alcohol consumption

时间窗: 26 weeks after baseline

Abstinence or controlled use of alcohol in the last 30 days 26 weeks after treatment start as measured with the timeline follow-back method

次要结局

  • Alcohol consumption(8 weeks after baseline)
  • Alcohol related contact with the Health Care system(One year after baseline)

研究者

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

Kjeld Andersen

Professor, MD

University of Southern Denmark

研究点 (1)

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