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Mental Contrasting With Implementation Intentions for Alcohol Use Disorders (MCIIAUD)

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MCII
Treatment as usual
Sponsored by
Susanne Rösner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring MCII, Alcohol Use Disorder, Motivation, Mental Contrasting, Implementation Intentions, Abstinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forel Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mental Contrasting with Implementation Intentions (MCII)

Treatment as usual

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Number of participants with return to any drinking
Any drinking as measured by self-report or objective testing
Rate of number of drinking events during treatment
Drinking Events as measured by self-report

Secondary Outcome Measures

Number of participants with early treatment termination
Treatment Termination without consent between patient and therapist
Rate of general self-efficacy for abstinence
self-efficacy will be assessed on the proposal of Ludwig, Tadayon-Manssuri, Strik, and Moggi (2013) to measure self-efficacy with simply one question ("How confident are you that you will be completely abstinent in 1 year, on a scale from 1 to 10?"). This scale is called "general self-efficacy". Lower scores indicate low self-efficacy and therefore a worse outcome; higher scores indicate a high self-efficacy and consequently a better outcome. We changed this question for different time intervals (e.g. the next fourteen days, until the end of treatment). The subscales are analyzed individually.
Rate of goal commitment for abstinence
Goal commitment will be assessed with the "Commitment to Sobriety Scale" (Kelly & Greene, 2014). It is a brief five-item measure to assess level of client commitment to alcohol and drug use cessation and continued abstinence. Each item is rated on a 6-point Likert scale from strongly disagree (1) to strongly agree (6). Lower scores indicate low commitment to sobriety and therefore a worse outcome; higher scores indicate a high commitment to sobriety and consequently a better outcome. A total score will be computed.

Full Information

First Posted
August 31, 2018
Last Updated
February 3, 2020
Sponsor
Susanne Rösner
Collaborators
University of Konstanz, Zurich University of Applied Sciences, New York University, University of Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03684798
Brief Title
Mental Contrasting With Implementation Intentions for Alcohol Use Disorders
Acronym
MCIIAUD
Official Title
Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Rösner
Collaborators
University of Konstanz, Zurich University of Applied Sciences, New York University, University of Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
MCII, Alcohol Use Disorder, Motivation, Mental Contrasting, Implementation Intentions, Abstinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mental Contrasting with Implementation Intentions (MCII)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MCII
Intervention Description
In this study, the research staff will work through the MCII approach with the participant as an interactive, face-to-face training. The desired future consists of imaging an abstinent life and comparing it with personally relevant obstacles. Afterwards, the most relevant obstacle will be chosen and an if-then-plan will be formed, that refers to this obstacle.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
The patients in the control group will receive a 2 x 2 contingency table about the disadvantages and advantages of being abstinent and of drinking. In addition, abstinence intentions of patients in the control group will also be supported and risk situations and relapse events since the last trainings will be reappraised, but without the use of MCII.
Primary Outcome Measure Information:
Title
Number of participants with return to any drinking
Description
Any drinking as measured by self-report or objective testing
Time Frame
through study completion at end of treatment, an average of 10 weeks
Title
Rate of number of drinking events during treatment
Description
Drinking Events as measured by self-report
Time Frame
through study completion at end of treatment, an average of 10 weeks
Secondary Outcome Measure Information:
Title
Number of participants with early treatment termination
Description
Treatment Termination without consent between patient and therapist
Time Frame
through study completion at end of treatment, an average of 10 weeks
Title
Rate of general self-efficacy for abstinence
Description
self-efficacy will be assessed on the proposal of Ludwig, Tadayon-Manssuri, Strik, and Moggi (2013) to measure self-efficacy with simply one question ("How confident are you that you will be completely abstinent in 1 year, on a scale from 1 to 10?"). This scale is called "general self-efficacy". Lower scores indicate low self-efficacy and therefore a worse outcome; higher scores indicate a high self-efficacy and consequently a better outcome. We changed this question for different time intervals (e.g. the next fourteen days, until the end of treatment). The subscales are analyzed individually.
Time Frame
through study completion at end of treatment, an average of 10 weeks
Title
Rate of goal commitment for abstinence
Description
Goal commitment will be assessed with the "Commitment to Sobriety Scale" (Kelly & Greene, 2014). It is a brief five-item measure to assess level of client commitment to alcohol and drug use cessation and continued abstinence. Each item is rated on a 6-point Likert scale from strongly disagree (1) to strongly agree (6). Lower scores indicate low commitment to sobriety and therefore a worse outcome; higher scores indicate a high commitment to sobriety and consequently a better outcome. A total score will be computed.
Time Frame
through study completion at end of treatment, an average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Rösner
Organizational Affiliation
Forel Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forel Klinik
City
Ellikon
State/Province
Zurich
ZIP/Postal Code
8548
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Oettingen G. Expectancy effects on behavior depend on self-regulatory thought. Social Cognition 18(2): 101-129, 2000.
Results Reference
background
Citation
Oettingen G. Rethinking positive thinking: inside the new science of motivation. New York, NY: Penguin Random House, 2014.
Results Reference
background
PubMed Identifier
11374746
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.
Results Reference
background
Citation
Gollwitzer PM. Weakness of the will: Is a quick fix possible? Motivation and Emotion 38: 305-322, 2014.
Results Reference
background

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Mental Contrasting With Implementation Intentions for Alcohol Use Disorders

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