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临床试验/NCT03764969
NCT03764969已完成不适用

Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction

Central Institute of Mental Health, Mannheim2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Change in imbalance between goal-directed and habitual behavior

研究概览

简要总结

This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.

详细描述

In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe tobacco use disorder (TUD) according to DSM-5
  • sufficient ability to communicate with investigators and answer questions in both written and verbal format
  • ability to provide fully informed consent and to use self-rating scales

排除标准

  • severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
  • history of brain injury
  • severe physical diseases
  • common exclusion criteria for MRI (e.g. metal, claustrophobia)
  • positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
  • psychotropic medication within the last 14 days
  • pregnancy

结局指标

主要结局

Change in imbalance between goal-directed and habitual behavior

时间窗: 2 time points: before and after 6 weeks SCP

measured by reward devaluation procedure (Hogarth \& Chase 2011)

Change in implicit smoking-related associations

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

smoking-related implicit association task (Wiers et al. 2016).

Change in working memory capacity

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

Change in cognitive flexibility

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

Change in smoking urges

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

questionnaire of smoking urges (QSU, Müller et al. 2001)); self-report questionnaire; two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving

Change in attentional bias to smoking cues

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

smoking-related dot-probe task (Vollstädt-Klein et al. 2009).

Change in planning ability

时间窗: 3 time points: before and after 6 weeks SCP plus after 3 months

One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

次要结局

  • nicotine consumption(3 months follow-up)
  • Change in neural PIT effect(2 time points: before and after 6 weeks SCP)
  • Change in neural cue reactivity(2 time points: before and after 6 weeks SCP)

研究者

发起方
Central Institute of Mental Health, Mannheim
申办方类型
Other
责任方
Sponsor

研究点 (2)

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