Alcohol Use DisorderMCIIAUDNCT03684798
Mental Contrasting With Implementation Intentions for Alcohol Use Disorders
A study testing MCII and Treatment as usual in people with Alcohol Use Disorder, run by Susanne Rösner at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- MCII and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2017to 4 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
- Age: ≥18 years
Who cannot join
- Cognitive deficits that limit the patients' ability to provide informed consent
- Inability to follow the procedures of the study
- Acute suicidality
- Acute psychosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Alcohol Use Disorder
- Being tested
- MCII, Treatment as usual
- Keywords
- MCII, Alcohol Use Disorder, Motivation, Mental Contrasting, Implementation Intentions, Abstinence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCIIOther
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.
Treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental Contrasting with Implementation Intentions (MCII) | Experimental | 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). Receives: Other: MCII |
| Treatment as usual | Active comparator | 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 Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with return to any drinking
Any drinking as measured by self-report or objective testing
Measured: through study completion at end of treatment, an average of 10 weeks
Rate of number of drinking events during treatment
Drinking Events as measured by self-report
Measured: through study completion at end of treatment, an average of 10 weeks
Secondary outcomes (3)
Number of participants with early treatment termination
Treatment Termination without consent between patient and therapist
Measured: through study completion at end of treatment, an average of 10 weeks
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.
Measured: through study completion at end of treatment, an average of 10 weeks
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.
Measured: through study completion at end of treatment, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start14 Aug 2017
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Rösner
- Sponsor type
- University, hospital or other
- Collaborators
- University of Konstanz, Zurich University of Applied Sciences, New York University, University of Hamburg-Eppendorf
- Responsible party
- Sponsor-investigator, Susanne Rösner, Forel Clinic
- Investigators
- Susanne Rösner, Principal investigator, Forel Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684798
- Sponsor's protocol ID
- 2017-1
- Acronym
- MCIIAUD
- Status last verified
- Feb 2020
- First submitted
- 31 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oettingen G. Expectancy effects on behavior depend on self-regulatory thought. Social Cognition 18(2): 101-129, 2000.
Oettingen G. Rethinking positive thinking: inside the new science of motivation. New York, NY: Penguin Random House, 2014.
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.
PubMed 11374746Gollwitzer PM. Weakness of the will: Is a quick fix possible? Motivation and Emotion 38: 305-322, 2014.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03684798
- Acronym / sponsor ID
- MCIIAUD / 2017-1
- Conditions
- Alcohol Use Disorder
- Keywords
- MCII, Alcohol Use Disorder, Motivation, Mental Contrasting, Implementation Intentions, Abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Susanne RösnerUniversity, hospital or other
- Collaborators
- University of Konstanz, Zurich University of Applied Sciences, New York University, University of Hamburg-Eppendorf
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Contrasting with Implementation Intentions (MCII) | Experimental | Other: MCIIMental 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). |
| Treatment as usual | Active comparator | Other: Treatment as usualThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
- Age: ≥18 years
Key exclusion criteria (4 listed)
- Cognitive deficits that limit the patients' ability to provide informed consent
- Inability to follow the procedures of the study
- Acute suicidality
- Acute psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCIIIn 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. | Other | Mental Contrasting with Implementation Intentions (MCII) |
| Treatment as usualThe 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. | Other | Treatment as usual |
Primary outcome
Number of participants with return to any drinking
Time frame: 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
Time frame: through study completion at end of treatment, an average of 10 weeks
Drinking Events as measured by self-report
3 secondary outcomes
Number of participants with early treatment termination
Time frame: through study completion at end of treatment, an average of 10 weeks
Rate of general self-efficacy for abstinence
Time frame: through study completion at end of treatment, an average of 10 weeks
Rate of goal commitment for abstinence
Time frame: through study completion at end of treatment, an average of 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- BackgroundOettingen G. Expectancy effects on behavior depend on self-regulatory thought. Social Cognition 18(2): 101-129, 2000.
- BackgroundOettingen G. Rethinking positive thinking: inside the new science of motivation. New York, NY: Penguin Random House, 2014.
- Background: PubMed 11374746Oettingen 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.
- BackgroundGollwitzer PM. Weakness of the will: Is a quick fix possible? Motivation and Emotion 38: 305-322, 2014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Rösner principal investigator
Forel Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCII and Treatment as usual in people with Alcohol Use Disorder, run by Susanne Rösner at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with return to any drinking (time frame: through study completion at end of treatment, an average of 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684798, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.