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CompletedNCT05167097MindsetBI-RUpdated May 10, 2023

Mindsets and the Effectiveness of a Brief Intervention - Replication

An interventional study of ASSIST-linked Brief Intervention and Mindset Intervention in Alcohol Drinking and Cannabis Use, sponsored by University of Konstanz. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by University of Konstanz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alcohol Drinking
  • Cannabis Use

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03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 125 is close to the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Konstanz is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • AUDIT > 8 in a prescreening

Exclusion criteria

Exclusion Criteria:

  • Alcohol use disorder or substance use disorder
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
125 participants (actual)

Study arms

  • Experimental
    Deliberative Mindset

    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

  • Experimental
    Implemental Mindset

    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

  • Experimental
    Decisional Balance BI

    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

  • Experimental
    No Decisional Balance BI

    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

  • Other
    Control Group

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

    Other: Mindset Intervention

Interventions

  • OtherASSIST-linked Brief Intervention

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

  • OtherMindset Intervention

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

06

What researchers measure

Primary outcomes

  1. Change in Alcohol Use

    Assessed via the Timeline Followback method

    Time frame: 4 weeks before and 4 weeks after the intervention

  2. Change in THC Use

    Assessed via the Timeline Followback method

    Time frame: 4 weeks before and 4 weeks after the intervention

Secondary outcomes

  1. 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)

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

  2. Change in Individual Risk Perception (alcohol-specific)

    Assessed via the Questionnaire to assess alcohol-related risk perception

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

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Study locations

1 site
  • University of Konstanz
    Konstanz, Baden-Württemberg 78462, Germany
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References and documents

Individual participant data

Plan to share: Yes — In an anonymized data file on a public repository.

Supporting information: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05167097
Lead sponsor
University of Konstanz
Responsible party
Lucas Keller (Principal investigator, University of Konstanz) — Principal investigator
First posted
Dec 22, 2021
Start date
Nov 8, 2021
Primary completion
Mar 2, 2023
Completion
Mar 2, 2023
Last update
May 10, 2023

Study contacts

Lucas Keller, PhD
principal investigator · University of Konstanz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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