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临床试验/NCT04498988
NCT04498988
已完成
不适用

Volitional Dysfunction in Self-control Failures and Addictive Behaviors

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 338 人2014年12月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Addictive Behavior
发起方
Technische Universität Dresden
入组人数
338
试验地点
1
主要终点
Changes in quantity and frequency of addictive behaviors
状态
已完成
最后更新
去年

概览

简要总结

The aim of this project is to elucidate whether impairments of cognitive control, performance-monitoring, and value-based decision-making and dysfunctional interactions between underlying brain systems are mediating mechanisms and vulnerability factors for daily self-control failures and addictive disorders.

详细描述

Failures of self-control during conflicts between long-term goals and immediate desires are a key characteristic of many harmful behaviors, including unhealthy eating habits, lack of exercise and problematic substance use, which often have adverse personal consequences and incur great societal costs. The project aims to elucidate neurocognitive mechanisms mediating deficient self-control, both in daily self-control failures and in substance use disorders and behavioral addictions, which are characterized by a loss of control despite awareness of adverse consequences. A prospective cohort study was launched using a multi-level approach that combines (i) a comprehensive clinical assessment, (ii) behavioral task batteries assessing cognitive control and decision-making functions, (iii) task-related and resting state fMRI, and (iv) Smartphone-based ecological momentary assessment of daily self-control failures. From a representative community sample, three groups of participants were recruited (each n = 100; age 20 - 26) with (a) symptoms of non-substance related and (b) substance-related addictive disorders and (c) syndrome-free controls. Participants are invited to yearly clinical follow-up assessments and further multi-level assessments 3 and 6 years after initial recruitment. Results obtained so far (until 06/2020) provide converging evidence that task performance as well as brain activity in monitoring, control, and valuation networks is reliably associated with the propensity to commit real-life self-control failures. Results support a process model, according to which deficient performance-monitoring leads to an insufficient recruitment of control networks, which attenuates the impact of long-term goals on neural value signals and increases the likelihood of self-control failures. In the final funding period (until 06/2024), the clinical follow-up period will be extended to 7 years. In addition, stress markers will be assessed as possible moderators of self-control. With the cross-lagged panel design it is expected to make a substantial contribution to the central unresolved question whether dysfunctions of cognitive control are causally involved in the development and trajectories of self-control failures and addictive behaviors, as well as to the disputed question of communalities and differences between different addictive disorders. Thereby, the project will to contribute to mechanism-based models of self-control impairments as a foundation for improved prevention and therapy.

注册库
clinicaltrials.gov
开始日期
2014年12月1日
结束日期
2024年6月30日
最后更新
去年
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in quantity and frequency of addictive behaviors

时间窗: At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline

Changes in quantity and frequency of addictive behaviours, which are combined into a quantity-frequency index.

Changes in addictive disorder severity

时间窗: At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline

Changes in number of fulfilled criteria according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)

Changes in neural correlates of response inhibition

时间窗: At baseline and 3 and 6 years after baseline

Blood oxygenation level dependent (BOLD) responses in tasks measuring response inhibition (Go/Nogo, Stroop) using 3 Tesla functional magnetic resonance imaging (fMRI).

Changes in neural correlates of value-based decision-making

时间窗: At baseline and 3 and 6 years after baseline

BOLD responses in a task measuring value-based decision-making using 3 Tesla fMRI.

Changes in structural brain characteristics

时间窗: At baseline and 3 and 6 years after baseline

Gray matter volume, cortical thickness and white matter properties in theoretically motivated regions of interest (e.g., right inferior frontal gyrus (rIFG), ventromedial prefrontal cortex (vmPFC), anterior cingulate cortex (ACC), anterior insula (aINS)) using 3 Tesla structural MRI.

Changes in real-life self-control

时间窗: At baseline and 3 and 6 years after baseline

Everyday self-control was assessed using an Ecological Momentary Assessment (EMA) protocol adapted from Hofmann, Baumeister, Förster, and Vohs (2012). Self-control was defined as enactment of desires in conflict-laden situations.

Changes in cognitive control abilities

时间窗: At baseline and 3 and 6 years after baseline

The Cognitive Control Task Battery of the Collaborative Research Center (CRC) 940 with nine executive function tasks (Stroop, AX continuous performance, color-shape, stop signal, letter memory, number-letter, go-nogo, 2-back, category switch) is used to derive a latent variable representing individual differences in general executive functioning (GEF). For the latent variable modelling error rates and reaction times from the tasks were combined, were appropriate, into inverse efficiency scores (IESs).

Changes in neural correlates of error monitoring

时间窗: At baseline and 3 and 6 years after baseline

BOLD responses in a task measuring error monitoring (Stroop) using 3 Tesla fMRI.

Changes in impulsive decision-making

时间窗: At baseline and 3 and 6 years after baseline

The Value-Based Decision-Making (VBDM) battery of the Collaborative Research Center (CRC) 940 including four decision-making tasks with a Bayesian adaptive algorithm was used to adaptively assess impulsive decision-making. For the delay and probability discounting tasks, a hyperbolic value function was used describing that the subjective values of delayed (or probabilistic) reward decline hyperbolically according to the discounting rate k. For the mixed gambles task, a simple linear function was used in which loss aversion (λ) is the relative weighting of losses to gains in the participant's. Individuals with higher impulsive decision-making are assumed to display higher k values in the delay discounting task, lower k values in probability discounting tasks, and lower λ values in the mixed gambles task.

次要结局

  • Personality(At baseline)
  • Changes in impulsivity(At baseline and 3 and 6 years after baseline)
  • Positive and negative affect(At baseline)
  • Changes in self control(At baseline and 3 and 6 years after baseline)
  • Changes in chronic stress(At baseline and 3 and 6 years after baseline)
  • Intelligence(At baseline)
  • Changes in the action and state orientation(At baseline and 3 and 6 years after baseline)

研究点 (1)

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