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TerminatedNCT03338491AddRiskStudUpdated Mar 25, 2020

Addiction Risk: Mindset Induction Effect on Brief Intervention

An interventional study of Induction of Implemental Mindset and Induction of Deliberative Mindset in Alcohol Drinking in College, sponsored by University of Konstanz. Terminated at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Konstanz · Not applicable, Interventional, and Prevention

Why this study was terminated
unexpected alcohol use increase identified in preliminary analysis after half of study enrollments
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Drinking in College
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • acute psychosis, acute suicidality, illiteracy
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • 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).

    Behavioral: Induction of Implemental Mindset

  • 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).

    Behavioral: Induction of Deliberative Mindset

  • No intervention
    Control

    Participants will revive no induction of any mindset.

Interventions

  • BehavioralInduction of Implemental Mindset

    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."

  • BehavioralInduction of Deliberative 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."

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 4 weeks

  2. 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)

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

06

Study locations

1 site
  • University of Konstanz, Psychotherapy Outpatient Clinic
    Konstanz, 78464, Germany
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03338491
Lead sponsor
University of Konstanz
Responsible party
Michael Odenwald (Director Outpatient Clinic or Psychotherapy, University of Konstanz) — Principal investigator
First posted
Nov 9, 2017
Start date
Nov 21, 2017
Primary completion
Oct 31, 2018
Completion
Apr 30, 2019
Last update
Mar 25, 2020

Study contacts

Michael Odenwald, PhD
principal investigator · University of Konstanz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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