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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03339687
Other study ID # OD 113/2-1(2)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2017
Est. completion date December 31, 2020

Study information

Verified date April 2021
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. Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened for risky alcohol use. All patients 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 Gollwitzer. The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - admitted to treatment at psychotherapy outpatient clinic Exclusion Criteria: - alcohol use disorder - substance use disorder

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental Mindset Induction
This induction of a psychological state was extensively studied in 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 positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required. 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."

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 Individual Risk Perception The participant's self-reported risk of experiencing alcohol-related problems is measured with the self-report measure "Questionnaire for Alcohol-related Risk Perception" (German "Fragebogen zur Alkoholbezogenen Risikowahrnehmung", FAR; Klepper, Odenwald & Rockstroh (2016). Risikowahrnehmung und Alkoholabhängigkeit. SUCHT, 62 (6), 374-382; DOI 10.1024/0939-5911/a000457). The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
Secondary Amount of alcohol drinking Self-reported amount of standard units of alcohol consumed by the individual The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
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