Alcohol Use Disorder (AUD)PathRiskNCT04985786
Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
A study testing Cognitive Behavioral Therapy for reducing risk behaviors and Cognitive Behavioral Therapy for increasing non-risk behaviors in people with Alcohol Use Disorder (AUD) and Schizophrenia and Related Disorders, run by University of Konstanz at 1 site in Germany.
Trial summary
The hyper- or hypo-attribution of risks is deeply related to the core pathological mechanisms of mental disorders and at the same time engaging in risky behaviors influences their course and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Schizophrenia and Related Disorders
- What is being tested?
- Cognitive Behavioral Therapy for reducing risk behaviors and Cognitive Behavioral Therapy for increasing non-risk behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jul 2021to 30 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both
Who cannot join
- for patient groups and healthy control group:
- no sufficient command of German language
- neurological disorder for patient groups:
- acute psychotic episode
- acute suicidality or not distanced from self-harming behaviors
- other substance use disorder (exception: nicotine and caffeine use disorders) for healthy control group:
- absence of any psychiatric diagnosis (exception: nicotine and caffeine use disorders)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Konstanz, Research Ward
Konstanz, 78464
Michael G Odenwald, Dr rer. nat., +49-7531-88-0 ext. 4621, michael.odenwald@uni-konstanz.de
Anna Becker, Dr. med., +49-7531-88-0 ext. 4618, anna.2.becker@uni-konstanz.de
About this study
Official title: Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
The hyper- or hypo-attribution of risks is deeply related to the core pathological mechanisms of mental disorders and at the same time engaging in risky behaviors influences their course and outcomes. The investigators study risk perception, risk behaviors and underlying brain mechanisms in a longitudinal design in three groups of psychiatric patients who participate in a psychological intervention that is aimed to reduce risk behavior and increase risk perception.
Patients with schizophrenia (SZ), alcohol use disorder (AUD) and both disorders (SZ + AUD) are recruited during psychiatric in-patient treatment and participate in a combined face-to-face and mobile intervention that starts before release and ends four weeks after discharge. The standardized 4-session face-to-face group intervention that is based on motivational interviewing (Miller \& Rollnick, 2013) and relapse prevention (Marlatt \& Donovan, 2005) and addresses the reduction of disorder-specific risk behaviors, i.e. alcohol use for AUD and SZ+AUD and medication non-adherence for SZ. After discharge, a 4-week ecological momentary intervention (EMI) supports participants to maintain abstinence from risk behaviors and to strengthen coping in high-risk situations relying on mental contrasting and implementation intentions (Oettingen \& Gollwitzer, 2011). Participants will be assessed in fMRI and behavioral measurements and by self-report pre and post interventional phase, furthermore they participate in an ecological momentary assessment during the post-discharge phase which assesses risk behaviors, high-risk situations and risk perception in real life contexts.
- Being tested
- Cognitive Behavioral Therapy for reducing risk behaviors, Cognitive Behavioral Therapy for increasing non-risk behaviors
- Medical subject headings
- Alcoholism, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for reducing risk behaviorsBehavioural
Cognitive Behavioral Therapy to reduce risk behaviors and increase risk perception that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. For SZ the target risk behavior is medication non-adherence and for AUD and AUD \& SZ it is alcohol use.
Cognitive Behavioral Therapy for increasing non-risk behaviorsBehavioural
Cognitive Behavioral Therapy to increase non-risk behaviors that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. In this control intervention for patient groups the target behavior is cognitive exercises.
| Study group | Role | What they receive |
|---|---|---|
| AUD Intervention | Experimental | Risk behavior specific intervention, targeting alcohol drinking Receives: Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors |
| AUD Control | Active comparator | Non-risk behavior specific intervention, targeting cognitive exercises Receives: Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors |
| AUD & SZ Intervention | Experimental | Risk behavior specific intervention, targeting alcohol drinking Receives: Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors |
| AUD & SZ Control | Active comparator | Non-risk behavior specific intervention, targeting cognitive exercises Receives: Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors |
| SZ Intervention | Experimental | Risk behavior specific intervention, targeting medication non-adherence Receives: Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors |
| SZ Control | Active comparator | Non-risk behavior specific intervention, targeting cognitive exercises Receives: Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors |
| HC Control | No intervention | Healthy control subjects will participate in fMRI assessments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Nucleus Accumbens activation and connectivity during risky decision making
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
Measured: 6 weeks
Engagement in risk behaviors
Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)
Measured: 4 weeks
Secondary outcomes (2)
Risk reappraisal
Change of risk perception after critical event depending on the outcome of the critical event (engaging is risk behavior or not) as defined by Klepper et al. (2017)
Measured: 4 weeks
Activation of amygdala, STS, mPFC and insula during risk evaluation
fMRI signal (BOLD) in a trustworthiness task
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start10 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Psychiatry Reichenau, Germany
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985786
- Sponsor's protocol ID
- OD 113/3-1
- Acronym
- PathRisk
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request ensuring the data protection laws are fulfilled
Publications
Klepper S, Odenwald M, Rosner S, Senn S, Menning H, Pereyra-Kroll D, Rockstroh B. Experience-Induced Change of Alcohol-Related Risk Perception in Patients with Alcohol Use Disorders. Front Psychol. 2017 Nov 13;8:1967. doi: 10.3389/fpsyg.2017.01967. eCollection 2017.
PubMed 29180975Gollwitzer P, Oettingen G (2011). Planning promotes goal striving. In: KD Vohs, RF Baumeister (Eds.), Handbook of Self-Regulation: Research, Theory, and Applications (2nd edition, chapter 9, pp. 162 - 184). The Guilford Press.
Marlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.
Miller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
- ClinicalTrials.gov ID
- NCT04985786
- Acronym / sponsor ID
- PathRisk / OD 113/3-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Centre for Psychiatry Reichenau, Germany
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 2 Aug 2021 (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.
The hyper- or hypo-attribution of risks is deeply related to the core pathological mechanisms of mental disorders and at the same time engaging in risky behaviors influences their course and outcomes. The investigators study risk perception, risk behaviors and underlying brain mechanisms in a longitudinal design in three groups of psychiatric patients who participate in a psychological intervention that is aimed to reduce risk behavior and increase risk perception.
Patients with schizophrenia (SZ), alcohol use disorder (AUD) and both disorders (SZ + AUD) are recruited during psychiatric in-patient treatment and participate in a combined face-to-face and mobile intervention that starts before release and ends four weeks after discharge. The standardized 4-session face-to-face group intervention that is based on motivational interviewing (Miller \& Rollnick, 2013) and relapse prevention (Marlatt \& Donovan, 2005) and addresses the reduction of disorder-specific risk behaviors, i.e. alcohol use for AUD and SZ+AUD and medication non-adherence for SZ. After discharge, a 4-week ecological momentary intervention (EMI) supports participants to maintain abstinence from risk behaviors and to strengthen coping in high-risk situations relying on mental contrasting and implementation intentions (Oettingen \& Gollwitzer, 2011). Participants will be assessed in fMRI and behavioral measurements and by self-report pre and post interventional phase, furthermore they participate in an ecological momentary assessment during the post-discharge phase which assesses risk behaviors, high-risk situations and risk perception in real life contexts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| AUD Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviorsRisk behavior specific intervention, targeting alcohol drinking |
| AUD Control | Active comparator | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviorsNon-risk behavior specific intervention, targeting cognitive exercises |
| AUD & SZ Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviorsRisk behavior specific intervention, targeting alcohol drinking |
| AUD & SZ Control | Active comparator | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviorsNon-risk behavior specific intervention, targeting cognitive exercises |
| SZ Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviorsRisk behavior specific intervention, targeting medication non-adherence |
| SZ Control | Active comparator | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviorsNon-risk behavior specific intervention, targeting cognitive exercises |
| HC Control | No intervention | –Healthy control subjects will participate in fMRI assessments only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both
Key exclusion criteria (7 listed)
- no sufficient command of German language
- neurological disorder for patient groups:
- acute psychotic episode
- acute suicidality or not distanced from self-harming behaviors
- other substance use disorder (exception: nicotine and caffeine use disorders) for healthy control group:
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 |
|---|---|---|
| Cognitive Behavioral Therapy for reducing risk behaviorsCognitive Behavioral Therapy to reduce risk behaviors and increase risk perception that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. For SZ the target risk behavior is medication non-adherence and for AUD and AUD \& SZ it is alcohol use. | Behavioural | AUD & SZ Intervention, AUD Intervention, SZ Intervention |
| Cognitive Behavioral Therapy for increasing non-risk behaviorsCognitive Behavioral Therapy to increase non-risk behaviors that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. In this control intervention for patient groups the target behavior is cognitive exercises. | Behavioural | AUD & SZ Control, AUD Control, SZ Control |
Primary outcome
Change of Nucleus Accumbens activation and connectivity during risky decision making
Time frame: 6 weeks
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
Engagement in risk behaviors
Time frame: 4 weeks
Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)
2 secondary outcomes
Risk reappraisal
Time frame: 4 weeks
Activation of amygdala, STS, mPFC and insula during risk evaluation
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 29180975Klepper S, Odenwald M, Rosner S, Senn S, Menning H, Pereyra-Kroll D, Rockstroh B. Experience-Induced Change of Alcohol-Related Risk Perception in Patients with Alcohol Use Disorders. Front Psychol. 2017 Nov 13;8:1967. doi: 10.3389/fpsyg.2017.01967. eCollection 2017.
- BackgroundGollwitzer P, Oettingen G (2011). Planning promotes goal striving. In: KD Vohs, RF Baumeister (Eds.), Handbook of Self-Regulation: Research, Theory, and Applications (2nd edition, chapter 9, pp. 162 - 184). The Guilford Press.
- BackgroundMarlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.
- BackgroundMiller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.
- Individual participant dataSharing planned: Yes. Data will be made available upon request ensuring the data protection laws are fulfilled
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for reducing risk behaviors and Cognitive Behavioral Therapy for increasing non-risk behaviors in people with Alcohol Use Disorder (AUD) and Schizophrenia and Related Disorders, 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 7 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: status not confirmed, as of the sponsor's last update on 11 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Odenwald, Dr. (+49 7531 884621, michael.odenwald@uni-konstanz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Nucleus Accumbens activation and connectivity during risky decision making (time frame: 6 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?
On the ClinicalTrials.gov record for NCT04985786, which also lists 4 linked publications.
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 11 Aug 2021.