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Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia

Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04985786
Acronym
PathRisk
Enrollment
240
Registered
2021-08-02
Start date
2021-07-10
Completion date
2023-04-30
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder (AUD), Schizophrenia and Related Disorders

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy for reducing risk behaviors

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.

BEHAVIORALCognitive Behavioral Therapy for increasing non-risk behaviors

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.

Sponsors

Centre for Psychiatry Reichenau, Germany
CollaboratorUNKNOWN
University of Konstanz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Change of Nucleus Accumbens activation and connectivity during risky decision making6 weeksChange of fMRI signal (BOLD) in Balloon Analogue Risk Task
Engagement in risk behaviors4 weeksAlcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)

Secondary

MeasureTime frameDescription
Risk reappraisal4 weeksChange 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)
Activation of amygdala, STS, mPFC and insula during risk evaluation6 weeksfMRI signal (BOLD) in a trustworthiness task

Countries

Germany

Contacts

Primary ContactMichael Odenwald, Dr.
michael.odenwald@uni-konstanz.de+49 7531 884621
Backup ContactDaniela Mier, Prof. Dr.
daniela.mier@uni-konstanz.de+49 7531 884672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026