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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03338491
Other study ID # OD 113/2-1(3)
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 21, 2017
Est. completion date April 30, 2019

Study information

Verified date March 2020
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 64
Est. completion date April 30, 2019
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- student status at University of Konstanz

- risky alcohol use in past 12 months

Exclusion Criteria:

- acute psychosis, acute suicidality, illiteracy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Induction 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."
Induction 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."

Locations

Country Name City State
Germany University of Konstanz, Psychotherapy Outpatient Clinic Konstanz

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 4 weeks
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