Clinical trial NCT03684798: Mental Contrasting With Implementation Intentions for Alcohol Use Disorders
Official title: Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: MCII
Alcohol Use Disorder
Motivation
Mental Contrasting
Implementation Intentions
Abstinence
Lead sponsor: Forel Clinic
Sponsor class: OTHER
Collaborators: name: University of Konstanz
name: Zurich University of Applied Sciences
name: New York University
name: University of Hamburg-Eppendorf
First posted: 2018-09-26
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

All randomized subjects will be included in the analyses, regardless of whether they terminate the study regularly or not. Analyses will be done according to the intention-to-treat method (ITT).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
* Age: ≥18 years

Exclusion Criteria:

* Cognitive deficits that limit the patients' ability to provide informed consent
* Inability to follow the procedures of the study
* Acute suicidality
* Acute psychosis

Primary outcomes:
measure: Number of participants with return to any drinking
timeFrame: through study completion at end of treatment, an average of 10 weeks
measure: Rate of number of drinking events during treatment
timeFrame: through study completion at end of treatment, an average of 10 weeks
Secondary outcomes:
measure: Number of participants with early treatment termination
timeFrame: through study completion at end of treatment, an average of 10 weeks
measure: Rate of general self-efficacy for abstinence
timeFrame: through study completion at end of treatment, an average of 10 weeks
measure: Rate of goal commitment for abstinence
timeFrame: through study completion at end of treatment, an average of 10 weeks
Other outcomes:
Locations:
city: Ellikon
country: Switzerland
facility: Forel Klinik
state: Zurich
Study officials:
affiliation: Forel Clinic
name: Susanne Rösner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oettingen G. Expectancy effects on behavior depend on self-regulatory thought. Social Cognition 18(2): 101-129, 2000.
citation: Oettingen G. Rethinking positive thinking: inside the new science of motivation. New York, NY: Penguin Random House, 2014.
citation: Oettingen G, Pak H, Schnetter K. Self-regulation of goal setting: turning free fantasies about the future into binding goals. J Pers Soc Psychol. 2001 May;80(5):736-53.
citation: Gollwitzer PM. Weakness of the will: Is a quick fix possible? Motivation and Emotion 38: 305-322, 2014.