- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03338491
Addiction Risk: Mindset Induction Effect on Brief Intervention (AddRiskStud)
Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2 (Student Sub-study): Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol use. In this study the investigators test the hypothesis that that an open Mindset increases the positive effects of BI.
University students take part in a voluntary screened for risky alcohol use. All students with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.
Participants receive a brief Mindset induction prior to receiving BI. They are are randomly assigned to either the induction of an open or a closed mindset according to the Mindset theory of action phases (Gollwitzer & Keller (2016). Mindset Theory. In: V. Zeigler-Hill, T.K. Shackelford (eds.), Encyclopedia of Personality and Individual Differences. New York: Springer).
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking after the Brief Intervention in relation to the mindset induced before receiving the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konstanz, Germany, 78464
- University of Konstanz, Psychotherapy Outpatient Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- student status at University of Konstanz
- risky alcohol use in past 12 months
Exclusion Criteria:
- acute psychosis, acute suicidality, illiteracy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Induction of Implemental Mindset
Psychological Intervention.
Participants are asked to work on a brief paper-and-pencil task that has been shown to induce an Implemental Mindset according to the Mindset theory of action phases (Gollwitzer & Keller (2016).
Mindset Theory.
In: V. Zeigler-Hill, T.K. Shackelford (eds.),
Encyclopedia of Personality and Individual Differences.
New York: Springer).
|
This induction of a psychological state was extensively studied in basic cognitive science.
Gollwitzer & Keller (2016, p.3): "The implemental mindset is evoked by asking participants to think of a personal project for which they have already made the decision to act but did not initiate any action yet.
Subsequently, participants are asked to list the steps necessary for successful goal attainment and to plan out in detail when, where, and how they intend to act on each of these steps."
|
Experimental: Induction of Deliberative Mindset
Psychological Intervention.
Participants are asked to work on a brief paper-and-pencil task that has been shown to induce a Deliberative Mindset according to the Mindset theory of action phases (Gollwitzer & Keller (2016).
Mindset Theory.
In: V. Zeigler-Hill, T.K. Shackelford (eds.),
Encyclopedia of Personality and Individual Differences.
New York: Springer).
|
This induction of a psychological state was extensively studied in basic cognitive science.
Gollwitzer & Keller (2016, p.3): "The deliberative mindset is evoked by asking participants to (a) name an unresolved, important personal problem that is causing rumination but for which they have not made a decision yet and (b) reflect on whether to take action or not.
Further, to enhance the depth of reflection, participants are requested to list a number of positive and negative, short- and long-term consequences of both deciding to act and deciding not to act; indicating the probability of the occurrence of each of these consequences is required."
|
No Intervention: Control
Participants will revive no induction of any mindset.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire on Alcohol-related Risk Perception
Time Frame: 4 weeks
|
Self-Report Measure that is filled out by the participant.
This German questionnaire was developed by Klepper, Odenwald & Rockstroh (2016).
|
4 weeks
|
Alcohol Time-line Follow Back
Time Frame: 4 weeks
|
Self-reported amount of standard alcohol units consumed.
The assessment is made with the calendar method developed by Sobell & Sobell (1995)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SOCRATES
Time Frame: 4 weeks
|
Questionnaire: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Miller, W. R., & Tonigan, J. S. (1996).
Assessing drinkers' motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).
Psychology of Addictive Behaviors 10, 81-89.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OD 113/2-1(3)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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