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

Not Applicable

• Conditions: Alcohol Use Disorder (AUD); Schizophrenia and Related Disorders
• Interventions: Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors; Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors

• Registration Number: NCT04985786
• Lead Sponsor: University of Konstanz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-10
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Status Verified: 2021-08
• Study First Posted: 2021-08-02
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-11
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AUD Intervention	Cognitive Behavioral Therapy for reducing risk behaviors	Risk behavior specific intervention, targeting alcohol drinking
AUD & SZ Intervention	Cognitive Behavioral Therapy for reducing risk behaviors	Risk behavior specific intervention, targeting alcohol drinking
SZ Intervention	Cognitive Behavioral Therapy for reducing risk behaviors	Risk behavior specific intervention, targeting medication non-adherence
AUD Control	Cognitive Behavioral Therapy for increasing non-risk behaviors	Non-risk behavior specific intervention, targeting cognitive exercises
SZ Control	Cognitive Behavioral Therapy for increasing non-risk behaviors	Non-risk behavior specific intervention, targeting cognitive exercises
AUD & SZ Control	Cognitive Behavioral Therapy for increasing non-risk behaviors	Non-risk behavior specific intervention, targeting cognitive exercises

Primary Outcome Measures

Name	Time	Method
Engagement in risk behaviors	4 weeks	Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)
Change of Nucleus Accumbens activation and connectivity during risky decision making	6 weeks	Change of fMRI signal (BOLD) in Balloon Analogue Risk Task

Secondary Outcome Measures

Name	Time	Method
Risk reappraisal	4 weeks	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)
Activation of amygdala, STS, mPFC and insula during risk evaluation	6 weeks	fMRI signal (BOLD) in a trustworthiness task

Trial Locations

Locations (1)

University of Konstanz, Research Ward; 🇩🇪 Konstanz, Germany