Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
PathRisk
Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
1 other identifier
interventional
240
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2021
CompletedFirst Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedAugust 11, 2021
August 1, 2021
1.5 years
July 22, 2021
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change of Nucleus Accumbens activation and connectivity during risky decision making
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
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)
4 weeks
Secondary Outcomes (2)
Risk reappraisal
4 weeks
Activation of amygdala, STS, mPFC and insula during risk evaluation
6 weeks
Study Arms (7)
AUD Intervention
EXPERIMENTALRisk behavior specific intervention, targeting alcohol drinking
AUD Control
ACTIVE COMPARATORNon-risk behavior specific intervention, targeting cognitive exercises
AUD & SZ Intervention
EXPERIMENTALRisk behavior specific intervention, targeting alcohol drinking
AUD & SZ Control
ACTIVE COMPARATORNon-risk behavior specific intervention, targeting cognitive exercises
SZ Intervention
EXPERIMENTALRisk behavior specific intervention, targeting medication non-adherence
SZ Control
ACTIVE COMPARATORNon-risk behavior specific intervention, targeting cognitive exercises
HC Control
NO INTERVENTIONHealthy control subjects will participate in fMRI assessments only
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Konstanzlead
- Centre for Psychiatry Reichenau, Germanycollaborator
Study Sites (1)
University of Konstanz, Research Ward
Konstanz, 78464, Germany
Related Publications (4)
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.
PMID: 29180975BACKGROUNDGollwitzer 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Psychologist Research Ward
Study Record Dates
First Submitted
July 22, 2021
First Posted
August 2, 2021
Study Start
July 10, 2021
Primary Completion
December 31, 2022
Study Completion
April 30, 2023
Last Updated
August 11, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication
- Access Criteria
- will be defined according to legal requirements
Data will be made available upon request ensuring the data protection laws are fulfilled