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

Study Overview
=================
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.

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

Conditions
-----------------
Alcohol Use Disorder (AUD), Schizophrenia and Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors
* Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUD Intervention<br>Risk behavior specific intervention, targeting alcohol drinking | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors<br>* 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.<br>|
| Active Comparator: AUD Control<br>Non-risk behavior specific intervention, targeting cognitive exercises | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors<br>* 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.<br>|
| Experimental: AUD & SZ Intervention<br>Risk behavior specific intervention, targeting alcohol drinking | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors<br>* 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.<br>|
| Active Comparator: AUD & SZ Control<br>Non-risk behavior specific intervention, targeting cognitive exercises | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors<br>* 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.<br>|
| Experimental: SZ Intervention<br>Risk behavior specific intervention, targeting medication non-adherence | Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors<br>* 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.<br>|
| Active Comparator: SZ Control<br>Non-risk behavior specific intervention, targeting cognitive exercises | Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors<br>* 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.<br>|
| No Intervention: HC Control<br>Healthy control subjects will participate in fMRI assessments only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk reappraisal | 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) | 4 weeks | 
| Activation of amygdala, STS, mPFC and insula during risk evaluation | fMRI signal (BOLD) in a trustworthiness task | 6 weeks |