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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Use Disorder (AUD) Schizophrenia and Related Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AUD Intervention

Risk behavior specific intervention, targeting alcohol drinking

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for reducing risk behaviors

Intervention Type BEHAVIORAL

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.

AUD Control

Non-risk behavior specific intervention, targeting cognitive exercises

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for increasing non-risk behaviors

Intervention Type BEHAVIORAL

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.

AUD & SZ Intervention

Risk behavior specific intervention, targeting alcohol drinking

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for reducing risk behaviors

Intervention Type BEHAVIORAL

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.

AUD & SZ Control

Non-risk behavior specific intervention, targeting cognitive exercises

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for increasing non-risk behaviors

Intervention Type BEHAVIORAL

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.

SZ Intervention

Risk behavior specific intervention, targeting medication non-adherence

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for reducing risk behaviors

Intervention Type BEHAVIORAL

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.

SZ Control

Non-risk behavior specific intervention, targeting cognitive exercises

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for increasing non-risk behaviors

Intervention Type BEHAVIORAL

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.

HC Control

Healthy control subjects will participate in fMRI assessments only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive 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.

Intervention Type BEHAVIORAL

Cognitive 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes