跳至主要内容
临床试验/NCT06494735
NCT06494735招募中不适用

Effect of the French Version if the Metagognitive Bibliotherapy Program "MYMCT" on Obsessive-compulsive Symptoms

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
114
试验地点
1
主要终点
Yale Brown Obsessive Compulsive Scale

研究概览

简要总结

Obsessive-compulsive disorder (OCD) is a psychiatric illness characterized by the presence of obsessions and/or compulsions. Without effective treatment, symptoms tend to worsen and become chronic. International guidelines recommend medication and/or psychotherapy as the first-line treatment for OCD. However, the majority of sufferers remain undertreated worldwide. This lack of access to care worsened during the Covid-19 pandemic. Much of this suffering could be avoided by facilitating access to evidence-based therapies. As such, many distance therapeutic interventions have recently developed, such as bibliotherapy. These unguided self-help programs are mostly based on approaches derived from cognitive behavioral therapies (CBTs). Specialized metacognition bibliotherapy is more specifically based on the hypothesis of a cognitive meta-level that affects off-line knowledge and on-line self-regulatory behaviors.

Yet, the majority of OCD sufferers are reported to exhibit inadequate metacognitive processing. Although these metacognitive abilities are often neglected in the OCD literature, they appear to play a significant causal role in the onset and maintenance of obsessive-compulsive symptoms. As a result, OCD-specific metacognitive treatments need to be developed to reduce symptomatology and improve quality of life for these patients. To date and to our knowledge, there is only one validated metacognitive bibliotherapeutic program for OCD. This manual is called "MyMCT: My MetaCognitive Training". A recent meta-analysis confirms its effectiveness with 373 participants from Germany, Switzerland and Russia in reducing obsessions and compulsions. Although these results are promising, MyMCT did not exist in a French version until 2021. Our team then translated the manual on a not-for-profit basis, and an independent translator at Nice University Hospital confirmed that it faithfully transcribed the meaning of the English version. This version has been freely available since November 2021 on the website of the Department of Psychiatry and Psychotherapy at Hamburg-Eppendorf University Medical Center (https://clinical-neuropsychology.de/metacognitive-training-for-ocd-mymct/).

The investigator propose to carry out a single-center randomized controlled research protocol concerning the effects of the French version of MyMCT in OCD patients. This clinical trial will be carried out́ in collaboration with Professor Moritz, author of MyMCT and renowned researcher.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • With OCD diagnosed by a psychiatrist,
  • Unchanged psychiatric medication over the past 3 months,
  • Have a good command of the French language,

排除标准

  • Person with a psychotic or bipolar comorbidity diagnosed by a psychiatric physician
  • Person participating simultaneously in another clinical trial interfering with the results of the present study

结局指标

主要结局

Yale Brown Obsessive Compulsive Scale

时间窗: 2 month

the intensity of obsessive-compulsive symptoms will be assessed using Yale Brown Obsessive Compulsive Scale (Y-BOCS). A global evaluation of symptoms (/40) is calculated using two subscores: 1. obsessions (/20); 2. compulsions (/20).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验