Mindsets and the Effectiveness of a Brief Intervention - Replication

NCT05167097 | Completed

• 1 other identifier: Mindset BI Replication 2021
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Interventions (BI) based on Motivational Interviewing are effective in reducing alcohol use. In this study, the investigators test the hypothesis that mindsets increase the positive effects of BI among a student sample of risky drinkers. Subjects will be students with risky alcohol use as identified by the AUDIT. All participants receive the World Health Organization's (WHO) ASSIST-linked BI in one of two forms. Either with or without a decisional balance element (Steps 6-9 from the ten steps of the intervention). Before the ASSIST-linked BI, participants are randomly assigned to one of three mindset conditions. They either deliberate upon an unsolved problem (deliberative mindset), plan the implementation of a set goal (implemental mindset), or perform a control task (control condition). The investigators measure the change in alcohol-related risk perceptions, treatment motivation, and alcohol drinking as assessed via the timeline follow-back method. The investigators also assess THC consumption during the study.

Conditions

Alcohol Drinking; Cannabis Use

Outcome Measures

Primary Outcomes (2)

• Change in Alcohol Use

  Assessed via the Timeline Followback method

  4 weeks before and 4 weeks after the intervention

• Change in THC Use

  Assessed via the Timeline Followback method

  4 weeks before and 4 weeks after the intervention

Secondary Outcomes (2)

• Change in Individual Risk Perception (general)

  In between two sessions (i.e., 4 weeks)

• Change in Individual Risk Perception (alcohol-specific)

  In between two sessions (i.e., 4 weeks)

Study Arms (5)

Deliberative Mindset

EXPERIMENTAL

Participants receive a paper/pencil questionnaire that evokes a deliberative mindset. The questionnaire asks participants to deliberate upon the positive and negative short- and long-term consequences of acting vs. not acting toward a goal. This procedure is based on previous research on the mindset theory of action phases.

Other: Mindset Intervention

Implemental Mindset

EXPERIMENTAL

Participants receive a paper/pencil questionnaire that evokes an implemental mindset. The questionnaire asks participants to plan the when, where, and how of taking five steps toward a goal. This procedure is based on previous research on the mindset theory of action phases.

Other: Mindset Intervention

Decisional Balance BI

EXPERIMENTAL

Participants receive the ASSIST-linked Brief Intervention via an interview with a trained interventionist. The decisional balance element describes Steps 6-9 of the ten steps of the manual. They include probing for the positive and negative sides of alcohol consumption, weighing them against each other, focusing on the negative sides, and asking participants how concerned they are regarding the negative sides.

Other: ASSIST-linked Brief Intervention

No Decisional Balance BI

EXPERIMENTAL

Participants receive the ASSIST-linked Brief Intervention via an interview with a trained interventionist. This is the short-form of the ASSIST-linked Brief Intervention. It drops the decisional balance element that is described above.

Other: ASSIST-linked Brief Intervention

Control Group

OTHER

Participants perform a filler task in the control group, crossing out a specific letter in paragraphs of nonsense text.

Other: Mindset Intervention

Interventions

ASSIST-linked Brief Intervention OTHER

WHO's ASSIST-linked Brief Intervention (with and without Steps 6-9, the decisional balance element)

Decisional Balance BI; No Decisional Balance BI

Mindset Intervention OTHER

Standard mindset manipulation as used in research by Peter M. Gollwitzer and colleagues

Control Group; Deliberative Mindset; Implemental Mindset

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• AUDIT \> 8 in a prescreening

You may not qualify if:

• Alcohol use disorder or substance use disorder

Sponsors & Collaborators

• University of Konstanz: lead

Study Sites (1)

University of Konstanz

Konstanz, Baden-Wurttemberg, 78462, Germany

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Lucas Keller, PhD

  University of Konstanz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking only applies to mindset manipulation.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 22, 2021
• Study Start: November 8, 2021
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Upon submission to a peer-reviewed journal and for at least 7 years as advised by the American Psychological Association
• Access Criteria: Anonymized data will be accessible to anyone with a link to the data file in the publication.

Locations

DE (1)