Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Number of participants with return to any drinking
研究概览
简要总结
Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high. The study aims to investigate the effects of a motivational training (Mental Contrasting with Implementation Interventions; MCII) as a therapeutic add-on to standard treatment in inpatients with Alcohol Use Disorders.
详细描述
Today's elaborated therapeutic interventions do not ensure sustainability of therapeutic success in alcohol-dependent patients. Thus, it is to develop and implement new therapeutic methods in order to increase regular treatment termination and continuous abstinence during treatment. Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high.
In the study, MCII is implemented as an add-on intervention in order to reduce the risk of a relapse during treatment and to decrease drop-outs from treatment in alcohol-dependent inpatients. Therefore, inpatients with alcohol use disorder (AUD) are randomly assigned to one of two groups. The experimental group does receive MCII, the control group an exercise from treatment as usual. In addition, patients undergo brief motivational screenings in form of self-report questionnaires at the beginning and during treatment in order to assess motivational mediation of treatment effects and drinking events. The effect of the MCII training will be examined on primary (drinking during treatment) and secondary outcome variables (early treatment termination, motivational changes after drinking events).
The Primary Outcome is return to drinking during treatment defined as any violation of total abstinence. Drinking is assumed if either a drinking event is reported by the patient or a Breathalyzer tests is positive.
Participants are allocated to the groups using randomisation with emphasis on equal group sizes in control and experimental group. The list of randomisation was generated with the online tool "Research Randomizer".
The investigator's a priori calculation of the required sample size is based on the primary outcome, i.e. return to any drinking during treatment. Given α=0.05 and 1-β=0.80 a one-sided z-test then yields a required sample size of 122 participants, i.e. 61 subjects in the intervention group and 61 subjects in the control group.
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 (Participant)
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
- •Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
- •Age: ≥18 years
排除标准
- •Cognitive deficits that limit the patients' ability to provide informed consent
- •Inability to follow the procedures of the study
- •Acute suicidality
- •Acute psychosis
研究组 & 干预措施
Mental Contrasting with Implementation Intentions (MCII)
Mental Contrasting with Implementation Intentions (MCII) combines two methods: Mental Contrasting and Implementation Intentions.
Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality (Oettingen, 2000, 2014; Oettingen, Pak, & Schnetter, 2001) in order to increase goal commitment when expectations of success are high (Gollwitzer, 2014). Implementation Intentions on the other hand specify when, where, and how to strive for a goal in form of an if-then-plan, e.g. "If situation Y is encountered, then I will perform the goal-directed response Z" (Gollwitzer, 2014; Wieber, Thürmer, & Gollwitzer, 2015).
干预措施: MCII (Other)
Treatment as usual
The control group receive a control training, which consists of an exercise from treatment as usual. Thus, patients in the control group are supported in their intention for abstinence and in the reappraisal of risk situations and relapse, while no individual motivational strategies are planned or provided
干预措施: Treatment as usual (Other)
结局指标
主要结局
Number of participants with return to any drinking
时间窗: through study completion at end of treatment, an average of 10 weeks
Any drinking as measured by self-report or objective testing
Rate of number of drinking events during treatment
时间窗: through study completion at end of treatment, an average of 10 weeks
Drinking Events as measured by self-report
次要结局
- Number of participants with early treatment termination(through study completion at end of treatment, an average of 10 weeks)
- Rate of general self-efficacy for abstinence(through study completion at end of treatment, an average of 10 weeks)
- Rate of goal commitment for abstinence(through study completion at end of treatment, an average of 10 weeks)
研究者
Susanne Rösner
Head of Research
Forel Clinic