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Mindsets and the Effectiveness of a Brief Intervention - Replication (MindsetBI-R)

Primary Purpose

Alcohol Drinking, Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ASSIST-linked Brief Intervention
Mindset Intervention
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Drinking

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AUDIT > 8 in a prescreening

Exclusion Criteria:

  • Alcohol use disorder or substance use disorder

Sites / Locations

  • University of Konstanz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Deliberative Mindset

Implemental Mindset

Decisional Balance BI

No Decisional Balance BI

Control Group

Arm Description

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.

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Change in Alcohol Use
Assessed via the Timeline Followback method
Change in THC Use
Assessed via the Timeline Followback method

Secondary Outcome Measures

Change in Individual Risk Perception (general)
Assessed via a single question asking participants how willing they are to take risks (on a 11-point scale)
Change in Individual Risk Perception (alcohol-specific)
Assessed via the Questionnaire to assess alcohol-related risk perception

Full Information

First Posted
October 29, 2021
Last Updated
May 9, 2023
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT05167097
Brief Title
Mindsets and the Effectiveness of a Brief Intervention - Replication
Acronym
MindsetBI-R
Official Title
Updating Risk (DFG 441551024) - Work Package 2 - Mindsets Influence the Effectiveness of a Brief Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this study, the investigators will try to advance our understanding of the effects of mindset inductions for coping with motivational interventions in hazardously drinking students. In an earlier study, the investigators found an interactive effect of implemental mindsets with motivational interviewing on actual risk behavior but not risk perception. The investigators will target potential underlying processes (e.g., resistance to change, commitment), as well as compensation and generalization effects by including the assessment of consumption of alternative risky substances. The investigators target consumption-related risks and address interactions between mindsets and motivational interviewing. Combining a mindset induction with a Screening and Brief Intervention tool in which the risk status of the individual was assessed, and the interventionist provided feedback, conducted a decisional balance exercise, and used techniques from motivational interviewing, the investigators found effects on risk taking but not risk perception. Neither general risk taking in the subscales of the Domain-Specific Risk-Taking Scale nor alcohol-related risk perception in a specific questionnaire was significantly affected by our manipulations. Still, participants in an implemental mindset managed to reduce their monthly alcohol consumption on average by about 7 to 8 standard units (equates to roughly five glasses of wine) while participants in a deliberative mindset actually increased their alcohol consumption by a similar amount. The investigators want to replicate the earlier findings while simultaneously enriching our research design with a) a control condition to test whether the implemental mindset decreased drinking, the deliberative mindset increased drinking, or both happened concurrently, b) test for compensation and/or generalization effects by including the assessment of another substance, namely Tetrahydrocannabinol (THC), to see if participants may compensate their reduced alcohol consumption by enhanced consumption of substitutes or if they can self-regulate the consumption of both, and c) to test whether the decisional balance element of the ASSIST-linked brief intervention is driving the differences between mindsets. Design. The experiment follows a 3 between (Mindset: deliberative vs. implemental vs. control) x 2 between (Brief Intervention: short-form [without decisional balance] vs. long-form [with decisional balance]) factorial experimental design. Main dependent variables are the Timeline Followback (TLFB)-based self-reports of substance consumption, alcohol-related risk perception, and moderating/mediating variables related to the brief intervention itself (e.g., commitment, openness, resistance to change). Hypotheses. In the control condition, the investigators expect to see similar results to earlier work on the effectiveness of motivational interviewing in reducing alcohol. In the deliberative and implemental mindset condition, however, the investigators expect to see a more nuanced picture, similar to our previous experiment. To better disentangle this, the investigators will include specific resistance and commitment ratings during the brief intervention session after the personalized feedback and after the decisional balance exercise that follows, the two subsequent parts of the brief intervention. The investigators hypothesize that deliberative mindset participants would show low resistance during personalized feedback but high resistance after the decisional balance exercise, and the opposite pattern for commitment. Implemental mindset participants, on the other hand, are expected to show the opposite pattern for resistance and commitment after the decisional balance exercise; it remains unclear, however, how this group will respond to the personalized feedback procedure. Furthermore, the investigators want to explore whether the reduction/increase in consumption is specific to the one substance that is addressed in the brief intervention or whether regulation of consumption also affects alternative substances in terms of generalization or compensation. The investigators use THC as a model substitute because of the high prevalence (e.g., 64% in an earlier study. Procedure. The procedure will be very similar to our previous experiment. Participants will first be screened using an online questionnaire, and only at-risk drinking individuals (as indicated by the AUDIT) will be invited to the first lab session. Participants then receive the mindset manipulation. The investigators will ensure that the interventionist will be blind to the participants' mindset condition and that the mindset manipulation will involve a problem or project that is not related to substance use. Thereafter, the interventionist will assess the individuals' risk behavior regarding a set of substances (using the WHO's ASSIST manual) in an interview setting and will give the participants individualized feedback on their consumption (i.e., the first phase of the brief intervention). The interventionist will then conduct a motivational interview about the participants' personal alcohol consumption (i.e., the second phase of the brief intervention). Afterward, the interventionist will rate how resistant the participants behaved during the intervention. Thereafter participants report their alcohol and THC consumption for the last four weeks using the TLFB and fill out a series of questionnaires. Four weeks later, participants are back for a second lab session in which they again fill out the same battery of questionnaires to assess their (alcohol-specific) risk perception and to assess their alcohol and THC consumption, again using the TLFB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Cannabis Use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
Masking only applies to mindset manipulation.
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deliberative Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
Implemental Mindset
Arm Type
Experimental
Arm Description
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.
Arm Title
Decisional Balance BI
Arm Type
Experimental
Arm Description
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.
Arm Title
No Decisional Balance BI
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
Participants perform a filler task in the control group, crossing out a specific letter in paragraphs of nonsense text.
Intervention Type
Other
Intervention Name(s)
ASSIST-linked Brief Intervention
Intervention Description
WHO's ASSIST-linked Brief Intervention (with and without Steps 6-9, the decisional balance element)
Intervention Type
Other
Intervention Name(s)
Mindset Intervention
Intervention Description
Standard mindset manipulation as used in research by Peter M. Gollwitzer and colleagues
Primary Outcome Measure Information:
Title
Change in Alcohol Use
Description
Assessed via the Timeline Followback method
Time Frame
4 weeks before and 4 weeks after the intervention
Title
Change in THC Use
Description
Assessed via the Timeline Followback method
Time Frame
4 weeks before and 4 weeks after the intervention
Secondary Outcome Measure Information:
Title
Change in Individual Risk Perception (general)
Description
Assessed via a single question asking participants how willing they are to take risks (on a 11-point scale)
Time Frame
In between two sessions (i.e., 4 weeks)
Title
Change in Individual Risk Perception (alcohol-specific)
Description
Assessed via the Questionnaire to assess alcohol-related risk perception
Time Frame
In between two sessions (i.e., 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AUDIT > 8 in a prescreening Exclusion Criteria: Alcohol use disorder or substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas Keller, PhD
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz
City
Konstanz
State/Province
Baden-Württemberg
ZIP/Postal Code
78462
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In an anonymized data file on a public repository.
IPD Sharing Time Frame
Upon submission to a peer-reviewed journal and for at least 7 years as advised by the American Psychological Association
IPD Sharing Access Criteria
Anonymized data will be accessible to anyone with a link to the data file in the publication.

Learn more about this trial

Mindsets and the Effectiveness of a Brief Intervention - Replication

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