An interventional study of Cognitive Behavioral Therapy for reducing risk behaviors and Cognitive Behavioral Therapy for increasing non-risk behaviors in Alcohol Use Disorder (AUD) and Schizophrenia and Related Disorders, sponsored by University of Konstanz. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by University of Konstanz · Not applicable, Interventional, and Basic science
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 240 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
for patient groups and healthy control group:
Risk behavior specific intervention, targeting alcohol drinking
Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors
Non-risk behavior specific intervention, targeting cognitive exercises
Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors
Risk behavior specific intervention, targeting alcohol drinking
Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors
Non-risk behavior specific intervention, targeting cognitive exercises
Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors
Risk behavior specific intervention, targeting medication non-adherence
Behavioral: Cognitive Behavioral Therapy for reducing risk behaviors
Non-risk behavior specific intervention, targeting cognitive exercises
Behavioral: Cognitive Behavioral Therapy for increasing non-risk behaviors
Healthy control subjects will participate in fMRI assessments only
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 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.
Change of Nucleus Accumbens activation and connectivity during risky decision making
Change of fMRI signal (BOLD) in Balloon Analogue Risk Task
Time frame: 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)
Time frame: 4 weeks
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)
Time frame: 4 weeks
Activation of amygdala, STS, mPFC and insula during risk evaluation
fMRI signal (BOLD) in a trustworthiness task
Time frame: 6 weeks
Plan to share: Yes — Data will be made available upon request ensuring the data protection laws are fulfilled
Time frame: 6 months after publication
Access criteria: will be defined according to legal requirements
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of Konstanz