Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use

Sponsor

University of Konstanz (Other)

Overall Status

Completed

CT.gov ID

NCT03339687

Collaborator

(none)

Enrollment

Location

Arms

43.7

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Behavioral: Experimental Mindset Induction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2: Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use

Actual Study Start Date :

May 11, 2017

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Induction of Open 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: 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."
Experimental: Induction of a Closed 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: 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."

Arm

Intervention/Treatment

Experimental: Induction of Open 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: 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."

Experimental: Induction of a Closed 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: Experimental Mindset Induction

Outcome Measures

Primary Outcome Measures

Individual Risk Perception [The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.]
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).

Secondary Outcome Measures

Amount of alcohol drinking [The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month]
Self-reported amount of standard units of alcohol consumed by the individual

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

admitted to treatment at psychotherapy outpatient clinic

Exclusion Criteria:

alcohol use disorder
substance use disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Konstanz, Psychotherapy Outpatient Clinic	Konstanz		Germany	78464

Sponsors and Collaborators

University of Konstanz

Investigators

Principal Investigator: Michael Odenwald, PhD, University of Konstanz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Odenwald, Director Outpatient Clinic for Psychotherapy, University of Konstanz

ClinicalTrials.gov Identifier:

NCT03339687

Other Study ID Numbers:

OD 113/2-1(2)

First Posted:

Nov 13, 2017

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Apr 19, 2021