NCT03338491

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

November 7, 2017

Last Update Submit

March 23, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    4 weeks

  • 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)

    4 weeks

Secondary Outcomes (1)

  • SOCRATES

    4 weeks

Study Arms (3)

Induction of Implemental Mindset

EXPERIMENTAL

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).

Behavioral: Induction of Implemental Mindset

Induction of Deliberative Mindset

EXPERIMENTAL

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).

Behavioral: Induction of Deliberative Mindset

Control

NO INTERVENTION

Participants will revive no induction of any mindset.

Interventions

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."

Induction of Implemental Mindset

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."

Induction of Deliberative Mindset

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • acute psychosis, acute suicidality, illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Psychotherapy Outpatient Clinic

Konstanz, 78464, Germany

Location

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Study Officials

  • Michael Odenwald, PhD

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Outpatient Clinic or Psychotherapy

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

November 21, 2017

Primary Completion

October 31, 2018

Study Completion

April 30, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations