Clinical trial NCT04985786: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
Official title: Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Schizophrenia and Related Disorders
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Centre for Psychiatry Reichenau, Germany
First posted: 2021-08-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change of Nucleus Accumbens activation and connectivity during risky decision making
timeFrame: 6 weeks
measure: Engagement in risk behaviors
timeFrame: 4 weeks
Secondary outcomes:
measure: Risk reappraisal
timeFrame: 4 weeks
measure: Activation of amygdala, STS, mPFC and insula during risk evaluation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Research Ward
Study officials:
References:
citation: 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.
citation: 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.
citation: Marlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.
citation: Miller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.