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Addiction Risk: Mindset Induction Effect on Brief Intervention (AddRiskStud)

Primary Purpose

Alcohol Drinking in College

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Induction of Implemental Mindset
Induction of Deliberative Mindset
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking in College

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • student status at University of Konstanz
  • risky alcohol use in past 12 months

Exclusion Criteria:

  • acute psychosis, acute suicidality, illiteracy

Sites / Locations

  • University of Konstanz, Psychotherapy Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Induction of Implemental Mindset

Induction of Deliberative Mindset

Control

Arm Description

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).

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).

Participants will revive no induction of any mindset.

Outcomes

Primary Outcome Measures

Questionnaire on Alcohol-related Risk Perception
Self-Report Measure that is filled out by the participant. This German questionnaire was developed by Klepper, Odenwald & Rockstroh (2016).
Alcohol Time-line Follow Back
Self-reported amount of standard alcohol units consumed. The assessment is made with the calendar method developed by Sobell & Sobell (1995)

Secondary Outcome Measures

SOCRATES
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.

Full Information

First Posted
November 7, 2017
Last Updated
March 23, 2020
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT03338491
Brief Title
Addiction Risk: Mindset Induction Effect on Brief Intervention
Acronym
AddRiskStud
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
unexpected alcohol use increase identified in preliminary analysis after half of study enrollments
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking in College

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction of Implemental Mindset
Arm Type
Experimental
Arm Description
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).
Arm Title
Induction of Deliberative Mindset
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will revive no induction of any mindset.
Intervention Type
Behavioral
Intervention Name(s)
Induction of Implemental Mindset
Intervention Description
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."
Intervention Type
Behavioral
Intervention Name(s)
Induction of Deliberative Mindset
Intervention Description
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."
Primary Outcome Measure Information:
Title
Questionnaire on Alcohol-related Risk Perception
Description
Self-Report Measure that is filled out by the participant. This German questionnaire was developed by Klepper, Odenwald & Rockstroh (2016).
Time Frame
4 weeks
Title
Alcohol Time-line Follow Back
Description
Self-reported amount of standard alcohol units consumed. The assessment is made with the calendar method developed by Sobell & Sobell (1995)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SOCRATES
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: student status at University of Konstanz risky alcohol use in past 12 months Exclusion Criteria: acute psychosis, acute suicidality, illiteracy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Odenwald, PhD
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz, Psychotherapy Outpatient Clinic
City
Konstanz
ZIP/Postal Code
78464
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Addiction Risk: Mindset Induction Effect on Brief Intervention

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