Alcohol DrinkingNCT03339687
Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
A study testing Experimental Mindset Induction in people with Alcohol Drinking, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Experimental Mindset Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2017to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to treatment at psychotherapy outpatient clinic
Who cannot join
- alcohol use disorder
- substance use disorder
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: 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.
Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened for risky alcohol use. All patients 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 Gollwitzer.
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking.
- Conditions
- Alcohol Drinking
- Being tested
- Experimental Mindset Induction
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Mindset InductionBehavioural
This induction of a psychological state was extensively studied in 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 positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required.
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."
| Study group | Role | What they receive |
|---|---|---|
| Induction of Open 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: Experimental Mindset Induction |
| Induction of a Closed 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: Experimental Mindset Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Risk Perception
The participant's self-reported risk of experiencing alcohol-related problems is measured with the self-report measure "Questionnaire for Alcohol-related Risk Perception" (German "Fragebogen zur Alkoholbezogenen Risikowahrnehmung", FAR; Klepper, Odenwald \& Rockstroh (2016). Risikowahrnehmung und Alkoholabhängigkeit. SUCHT, 62 (6), 374-382; DOI 10.1024/0939-5911/a000457).
Measured: The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
Secondary outcomes (1)
Amount of alcohol drinking
Self-reported amount of standard units of alcohol consumed by the individual
Measured: The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start11 May 2017
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- 66 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
- NCT03339687
- Sponsor's protocol ID
- OD 113/2-1(2)
- Status last verified
- Apr 2021
- First submitted
- 10 May 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. 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: Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
- ClinicalTrials.gov ID
- NCT03339687
- Acronym / sponsor ID
- OD 113/2-1(2)
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 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.
Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened for risky alcohol use. All patients 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 Gollwitzer.
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction of Open Mindset | Experimental | Behavioral: Experimental Mindset InductionPsychological 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). |
| Induction of a Closed Mindset | Experimental | Behavioral: Experimental Mindset InductionPsychological 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admitted to treatment at psychotherapy outpatient clinic
Key exclusion criteria (2 listed)
- alcohol use disorder
- substance use disorder
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 |
|---|---|---|
| Experimental Mindset InductionThis induction of a psychological state was extensively studied in 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 positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required. 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 Open Mindset, Induction of a Closed Mindset |
Primary outcome
Individual Risk Perception
Time frame: The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
The participant's self-reported risk of experiencing alcohol-related problems is measured with the self-report measure "Questionnaire for Alcohol-related Risk Perception" (German "Fragebogen zur Alkoholbezogenen Risikowahrnehmung", FAR; Klepper, Odenwald \& Rockstroh (2016). Risikowahrnehmung und Alkoholabhängigkeit. SUCHT, 62 (6), 374-382; DOI 10.1024/0939-5911/a000457).
1 secondary outcome
Amount of alcohol drinking
Time frame: The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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 Experimental Mindset Induction in people with Alcohol Drinking, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 19 Apr 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Individual Risk Perception (time frame: The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.). 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 19 Apr 2021.