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

Primary Purpose

Alcohol Use Disorder (AUD), Schizophrenia and Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for reducing risk behaviors
Cognitive Behavioral Therapy for increasing non-risk behaviors
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • University of Konstanz, Research WardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

No Intervention

Arm Label

AUD Intervention

AUD Control

AUD & SZ Intervention

AUD & SZ Control

SZ Intervention

SZ Control

HC Control

Arm Description

Risk behavior specific intervention, targeting alcohol drinking

Non-risk behavior specific intervention, targeting cognitive exercises

Risk behavior specific intervention, targeting alcohol drinking

Non-risk behavior specific intervention, targeting cognitive exercises

Risk behavior specific intervention, targeting medication non-adherence

Non-risk behavior specific intervention, targeting cognitive exercises

Healthy control subjects will participate in fMRI assessments only

Outcomes

Primary Outcome Measures

Change of Nucleus Accumbens activation and connectivity during risky decision making
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
Engagement in risk behaviors
Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)

Secondary Outcome Measures

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)
Activation of amygdala, STS, mPFC and insula during risk evaluation
fMRI signal (BOLD) in a trustworthiness task

Full Information

First Posted
July 22, 2021
Last Updated
August 3, 2021
Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04985786
Brief Title
Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
Acronym
PathRisk
Official Title
Pathological Risk: Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD), Schizophrenia and Related Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AUD Intervention
Arm Type
Experimental
Arm Description
Risk behavior specific intervention, targeting alcohol drinking
Arm Title
AUD Control
Arm Type
Active Comparator
Arm Description
Non-risk behavior specific intervention, targeting cognitive exercises
Arm Title
AUD & SZ Intervention
Arm Type
Experimental
Arm Description
Risk behavior specific intervention, targeting alcohol drinking
Arm Title
AUD & SZ Control
Arm Type
Active Comparator
Arm Description
Non-risk behavior specific intervention, targeting cognitive exercises
Arm Title
SZ Intervention
Arm Type
Experimental
Arm Description
Risk behavior specific intervention, targeting medication non-adherence
Arm Title
SZ Control
Arm Type
Active Comparator
Arm Description
Non-risk behavior specific intervention, targeting cognitive exercises
Arm Title
HC Control
Arm Type
No Intervention
Arm Description
Healthy control subjects will participate in fMRI assessments only
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for reducing risk behaviors
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for increasing non-risk behaviors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Nucleus Accumbens activation and connectivity during risky decision making
Description
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
Time Frame
6 weeks
Title
Engagement in risk behaviors
Description
Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Risk reappraisal
Description
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)
Time Frame
4 weeks
Title
Activation of amygdala, STS, mPFC and insula during risk evaluation
Description
fMRI signal (BOLD) in a trustworthiness task
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Odenwald, Dr.
Phone
+49 7531 884621
Email
michael.odenwald@uni-konstanz.de
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Mier, Prof. Dr.
Phone
+49 7531 884672
Email
daniela.mier@uni-konstanz.de
Facility Information:
Facility Name
University of Konstanz, Research Ward
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael G Odenwald, Dr rer. nat.
Phone
+49-7531-88-0
Ext
4621
Email
michael.odenwald@uni-konstanz.de
First Name & Middle Initial & Last Name & Degree
Anna Becker, Dr. med.
Phone
+49-7531-88-0
Ext
4618
Email
anna.2.becker@uni-konstanz.de
First Name & Middle Initial & Last Name & Degree
Alexander Wolber, MA
First Name & Middle Initial & Last Name & Degree
Natascha Büchele, MA

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
29180975
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.
Results Reference
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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.
Results Reference
background
Citation
Marlatt GA, Donovan, DM. Relapse Prevention. 2nd edition. The Guilford Press.
Results Reference
background
Citation
Miller R, Rollnick S (2013) Motivational Interviewing. 3rd edition. The Guilford Press.
Results Reference
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Dynamics of Risk Perception and Risk Behavior in Alcohol Use Disorder and Schizophrenia

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