Alcohol Use Disorder Clinical Trial
Official title:
Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders
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.
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).
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