Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05167097
Other study ID # Mindset BI Replication 2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date March 2, 2023

Study information

Verified date May 2023
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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - AUDIT > 8 in a prescreening Exclusion Criteria: - Alcohol use disorder or substance use disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ASSIST-linked Brief Intervention
WHO's ASSIST-linked Brief Intervention (with and without Steps 6-9, the decisional balance element)
Mindset Intervention
Standard mindset manipulation as used in research by Peter M. Gollwitzer and colleagues

Locations

Country Name City State
Germany University of Konstanz Konstanz Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Alcohol Use Assessed via the Timeline Followback method 4 weeks before and 4 weeks after the intervention
Primary Change in THC Use Assessed via the Timeline Followback method 4 weeks before and 4 weeks after the intervention
Secondary 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) In between two sessions (i.e., 4 weeks)
Secondary Change in Individual Risk Perception (alcohol-specific) Assessed via the Questionnaire to assess alcohol-related risk perception In between two sessions (i.e., 4 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Completed NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1