Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia (PathRisk)

University of Konstanz

Status: Unknown

Conditions: Alcohol Use Disorder (AUD); Schizophrenia and Related Disorders

Treatments: Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors; Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors

Study type: Interventional

Funder types: Other

Identifiers

NCT04985786

OD 113/3-1

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 7 patient groups

AUD Intervention

Experimental group

Description:

Risk behavior specific intervention, targeting alcohol drinking

Treatment:

Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors

AUD Control

Active Comparator group

Description:

Non-risk behavior specific intervention, targeting cognitive exercises

Treatment:

Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors

AUD & SZ Intervention

Experimental group

Description:

Risk behavior specific intervention, targeting alcohol drinking

Treatment:

Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors

AUD & SZ Control

Active Comparator group

Description:

Non-risk behavior specific intervention, targeting cognitive exercises

Treatment:

Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors

SZ Intervention

Experimental group

Description:

Risk behavior specific intervention, targeting medication non-adherence

Treatment:

Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors

SZ Control

Active Comparator group

Description:

Non-risk behavior specific intervention, targeting cognitive exercises

Treatment:

Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors

HC Control

No Intervention group

Description:

Healthy control subjects will participate in fMRI assessments only