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临床试验/NCT04985786
NCT04985786Unknown不适用

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

University of Konstanz2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
2
主要终点
Change of Nucleus Accumbens activation and connectivity during risky decision making

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patient groups: fulfilling the diagnostic criteria for AUD or SZ or both

排除标准

  • 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)

结局指标

主要结局

Change of Nucleus Accumbens activation and connectivity during risky decision making

时间窗: 6 weeks

Change of fMRI signal (BOLD) in Balloon Analogue Risk Task

Engagement in risk behaviors

时间窗: 4 weeks

Alcohol drinking (for AUD and AUD+SZ) and medication non-adherence (for SZ) as recorded by ecological momentary assessment (EMA)

次要结局

  • Risk reappraisal(4 weeks)
  • Activation of amygdala, STS, mPFC and insula during risk evaluation(6 weeks)

研究者

发起方
University of Konstanz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Odenwald

Chief Psychologist Research Ward

University of Konstanz

研究点 (2)

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