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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Odenwald, Dr.; Phone Number: +49 7531 884621; Email: michael.odenwald@uni-konstanz.de
• Study Contact Backup: Name: Daniela Mier, Prof. Dr.; Phone Number: +49 7531 884672; Email: daniela.mier@uni-konstanz.de

Study Locations

• Germany
  • Konstanz, Germany, 78464
    • Recruiting
    • University of Konstanz, Research Ward
    • Contact: Michael G Odenwald, Dr rer. nat.; Phone Number: 4621 +49-7531-88-0; Email: michael.odenwald@uni-konstanz.de
    • Contact: Anna Becker, Dr. med.; Phone Number: 4618 +49-7531-88-0; Email: anna.2.becker@uni-konstanz.de
    • Sub-Investigator: Alexander Wolber, MA
    • Sub-Investigator: Natascha Büchele, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AUD Intervention; Risk behavior specific intervention, targeting alcohol drinking	Behavioral: 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.
Active Comparator: AUD Control; Non-risk behavior specific intervention, targeting cognitive exercises	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.
Experimental: AUD & SZ Intervention; Risk behavior specific intervention, targeting alcohol drinking	Behavioral: 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.
Active Comparator: AUD & SZ Control; Non-risk behavior specific intervention, targeting cognitive exercises	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.
Experimental: SZ Intervention; Risk behavior specific intervention, targeting medication non-adherence	Behavioral: 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.
Active Comparator: SZ Control; Non-risk behavior specific intervention, targeting cognitive exercises	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.
No Intervention: HC Control; 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

Collaborators and Investigators

• Sponsor: University of Konstanz
• Collaborators: Centre for Psychiatry Reichenau, Germany

Publications and helpful links

General Publications

• Klepper S, Odenwald M, Rosner S, Senn S, Menning H, Pereyra-Kroll D, Rockstroh B. Experience-Induced Change of Alcohol-Related Risk Perception in Patients with Alcohol Use Disorders. Front Psychol. 2017 Nov 13;8:1967. doi: 10.3389/fpsyg.2017.01967. eCollection 2017.
• Gollwitzer P, Oettingen G (2011). Planning promotes goal striving. In: KD Vohs, RF Baumeister (Eds.), Handbook of Self-Regulation: Research, Theory, and Applications (2nd edition, chapter 9, pp. 162 - 184). The Guilford Press.
• Marlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.
• Miller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Alcohol Drinking; Alcoholism; Schizophrenia; Disease
• Other Study ID Numbers: OD 113/3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request ensuring the data protection laws are fulfilled
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: will be defined according to legal requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No