Alcohol Drinking in CollegeAddRiskStudNCT03338491
Addiction Risk: Mindset Induction Effect on Brief Intervention
A study testing Induction of Implemental Mindset and Induction of Deliberative Mindset in people with Alcohol Drinking in College, run by University of Konstanz at 1 site in Germany.
Trial 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. University students take part in a voluntary screened for risky alcohol use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking in College
- What is being tested?
- Induction of Implemental Mindset and Induction of Deliberative Mindset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 21 Nov 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- student status at University of Konstanz
- risky alcohol use in past 12 months
Who cannot join
- acute psychosis, acute suicidality, illiteracy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Konstanz, Psychotherapy Outpatient Clinic
Konstanz, 78464
About this study
Official title: Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2 (Student Sub-study): Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
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.
University students take part in a voluntary screened for risky alcohol use. All students with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.
Read more
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 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).
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking after the Brief Intervention in relation to the mindset induced before receiving the intervention.
- Conditions
- Alcohol Drinking in College
- Being tested
- Induction of Implemental Mindset, Induction of Deliberative Mindset
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of Implemental MindsetBehavioural
This induction of a psychological state was extensively studied in basic cognitive science. Gollwitzer \& Keller (2016, p.3): "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."
Induction of Deliberative MindsetBehavioural
This induction of a psychological state was extensively studied in basic 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 a number of positive and negative, short- and long-term consequences of both deciding to act and deciding not to act; indicating the probability of the occurrence of each of these consequences is required."
| Study group | Role | What they receive |
|---|---|---|
| Induction of Implemental Mindset | Experimental | 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). Receives: Behavioral: Induction of Implemental Mindset |
| Induction of Deliberative Mindset | Experimental | 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). Receives: Behavioral: Induction of Deliberative Mindset |
| Control | No intervention | Participants will revive no induction of any mindset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on Alcohol-related Risk Perception
Self-Report Measure that is filled out by the participant. This German questionnaire was developed by Klepper, Odenwald \& Rockstroh (2016).
Measured: 4 weeks
Alcohol Time-line Follow Back
Self-reported amount of standard alcohol units consumed. The assessment is made with the calendar method developed by Sobell \& Sobell (1995)
Measured: 4 weeks
Secondary outcomes (1)
SOCRATES
Questionnaire: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Miller, W. R., \& Tonigan, J. S. (1996). Assessing drinkers' motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors 10, 81-89.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start21 Nov 2017
- Primary completion31 Oct 2018
- Study completion30 Apr 2019
Why it stopped: unexpected alcohol use increase identified in preliminary analysis after half of study enrollments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Drinking in CollegeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
- Investigators
- Michael Odenwald, PhD, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338491
- Sponsor's protocol ID
- OD 113/2-1(3)
- Acronym
- AddRiskStud
- Status last verified
- Mar 2020
- First submitted
- 7 Nov 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2 (Student Sub-study): Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
- ClinicalTrials.gov ID
- NCT03338491
- Acronym / sponsor ID
- AddRiskStud / OD 113/2-1(3)
- Conditions
- Alcohol Drinking in College
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unexpected alcohol use increase identified in preliminary analysis after half of study enrollments
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
University students take part in a voluntary screened for risky alcohol use. All students 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 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).
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking after the Brief Intervention in relation to the mindset induced before receiving the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Induction of Implemental Mindset | Experimental | Behavioral: Induction of Implemental MindsetPsychological 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). |
| Induction of Deliberative Mindset | Experimental | Behavioral: Induction of Deliberative MindsetPsychological 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). |
| Control | No intervention | –Participants will revive no induction of any mindset. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- student status at University of Konstanz
- risky alcohol use in past 12 months
Key exclusion criteria (1 listed)
- acute psychosis, acute suicidality, illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of Implemental MindsetThis induction of a psychological state was extensively studied in basic cognitive science. Gollwitzer \& Keller (2016, p.3): "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." | Behavioural | Induction of Implemental Mindset |
| Induction of Deliberative MindsetThis induction of a psychological state was extensively studied in basic 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 a number of positive and negative, short- and long-term consequences of both deciding to act and deciding not to act; indicating the probability of the occurrence of each of these consequences is required." | Behavioural | Induction of Deliberative Mindset |
Primary outcome
Questionnaire on Alcohol-related Risk Perception
Time frame: 4 weeks
Self-Report Measure that is filled out by the participant. This German questionnaire was developed by Klepper, Odenwald \& Rockstroh (2016).
Alcohol Time-line Follow Back
Time frame: 4 weeks
Self-reported amount of standard alcohol units consumed. The assessment is made with the calendar method developed by Sobell \& Sobell (1995)
1 secondary outcome
SOCRATES
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: unexpected alcohol use increase identified in preliminary analysis after half of study enrollments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Odenwald, PhD principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of Implemental Mindset and Induction of Deliberative Mindset in people with Alcohol Drinking in College, run by University of Konstanz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unexpected alcohol use increase identified in preliminary analysis after half of study enrollments). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on Alcohol-related Risk Perception (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.