Cognitive and Metacognitive Remediation in Addiction Treatment: Randomized Controlled Trial of Efficacy in Parallel Arms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Change in General Self-Efficacy (SGSES-fr)
研究概览
简要总结
Cognitive and metacognitive remediation in addiction treatment: Value of Adding a cognitive remediation program to improve overall self-efficacy in patients with alcohol use disorder.
详细描述
Alcohol use disorder (AUD) is the third leading risk factor for morbidity worldwide and represents a major public health issue. It is associated with numerous somatic and psychological harms, as well as cognitive impairments that lead to a deterioration in quality of life and continued AUD. It is therefore essential that cognitive disorders be targeted for treatment, along with craving, emotional dysregulation, and erroneous beliefs. Similarly, strengthening the sense of self-efficacy plays a crucial role in the recovery of patients with AUD and helps consolidate their ability to cope with the challenges of daily life. Several studies have demonstrated the benefits of cognitive remediation, and the need to offer this type of care more systematically has been widely advocated in several literature reviews. Based on data from the literature and validated cognitive remediation programs, the R'COMET program was designed for patients with SUD. It combines cognitive remediation, emotion perception, and metacognition. The aim of this program is to improve cognitive and metacognitive functions and to enhance the sense of self-efficacy, which is a major determinant of recovery in addictive disorders.
The objective of the R'COMET study is to evaluate the effectiveness of this program on overall self-efficacy, cognitive and metacognitive performance, alcohol consumption, and quality of life in patients with AUD, at the end of the program and at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Single
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
- 否
入选标准
- •Aged between 18 and 65 (inclusive).
- •Native French speaker or educated in French.
- •Primary diagnosis of AUD according to DSM-5, with or without comorbid SUD.
- •Currently in withdrawal: abstinent for at least 7 days and no more than 30 days.
- •At least mild cognitive impairment, as measured by the BEARNI scale (mild impairment on the global scale or score below the threshold on at least one of the subtests).
排除标准
- •Guardianship.
- •Simultaneous participation in a cognitive rehabilitation group, an ETP programme or a mindfulness meditation group.
- •Presence of unstabilised psychiatric or addictive comorbidity. The notion of instability is assessed over the past month and is defined by: (i) the need to introduce a new psychotropic treatment, (ii) the need to increase the dosage of an existing psychotropic treatment, (iii) the need for hospitalisation. Given the profile of the patients sought, the start of psychotropic treatment or hospitalisation to support alcohol withdrawal will not be considered exclusion criteria.
- •Presence of neurodegenerative disease, Korsakoff's syndrome, mental retardation, or any other condition that may significantly interfere with the completion of assessments, as determined by the clinician.
研究组 & 干预措施
R'COMET treatment program (cognitive remediation program)
The program will include 10 weekly sessions in an open group format to facilitate the patient's engagement in the treatment program (the patient may join the group at any time). The sessions will last 2 hours, ideally with 4-5 patients per session.
Each session will include group and/or individual cognitive exercises to encourage interaction and the sharing of experiences, while also providing individualized and tailored support for each participant. Every cognitive exercise will be approached from a motivational perspective. The exercises offered during the sessions will be combined with systematic verbalization of strategies and emotional states, as well as psychoeducational, body-based, non-verbal communication, and cognitive-behavioral techniques. The proposed strategies will draw on both retrieval and compensatory approaches depending on the individual profiles.
A progress booklet will be given to the patient.
干预措施: cognitive remediation group (Behavioral)
Relaxation control program
The relaxation program consists of 10 weekly sessions lasting 2 hours, held in open groups of 4 to 5 participants. Each session follows a flexible structure with several phases: a welcome moment where participants identify and express their feelings, a musical listening period to help them settle into the session, and a self-massage activity to promote bodily awareness. This is followed by a guided relaxation phase-either passive or active-to encourage physical and mental release. At the end of the session, a different breathing exercise is introduced each week so participants can discover which technique suits them best. The session concludes with a verbalization period, allowing everyone to share their sensations and impressions in a supportive, non-judgmental environment. Participants are encouraged to practice the exercises independently as well .
干预措施: Relaxation control program (Behavioral)
结局指标
主要结局
Change in General Self-Efficacy (SGSES-fr)
时间窗: 6 months
The primary outcome measure will be the change in the overall score on the SGSES-fr scale between the pre-treatment assessment (V1) and the immediate post-treatment assessment (V2). The advantage of this scale over other self-efficacy scales is that it is not linked to specific situations or behaviors, but represents a general measure. The minimum value is 10 and the maximum value is 40. 10 is a high outcome 40 is a low outcome It is expected that this score will increase between V1 and V2.
次要结局
未报告次要终点