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

Alcohol Use Disorder (AUD) Clinical Trial

— PathRisk  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985786
• Other study ID #: OD 113/3-1
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2021
• Source: University of Konstanz
• Contact: Michael Odenwald, Dr.
• Phone: +49 7531 884621
• Email: michael.odenwald[@]uni-konstanz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism
• Disease
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University of Konstanz, Research Ward	Konstanz

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	Centre for Psychiatry Reichenau, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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.

Klepper S, Odenwald M, Rösner S, Senn S, Menning H, Pereyra-Kröll 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. — View Citation

Marlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.

Miller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Nucleus Accumbens activation and connectivity during risky decision making	Change of fMRI signal (BOLD) in Balloon Analogue Risk Task	6 weeks
Primary	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	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
Secondary	Activation of amygdala, STS, mPFC and insula during risk evaluation	fMRI signal (BOLD) in a trustworthiness task	6 weeks