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临床试验/NCT06466057
NCT06466057招募中不适用

The Efficacy of Metacognitive Therapy for Obsessive-compulsive Disorder

Northeast Normal University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Severity of participants' obsessive-compulsive symptoms

研究概览

简要总结

The goal of this clinical trial is to learn if metacognitive therapy can be effective in a Chinese sample of obsessive compulsive disorder (OCD) . The main questions it aims to answer are:

Can metacognitive therapy significantly reduce participants' levels of obsessive-compulsive symptoms? Can metacognitive therapy significantly improve participants' metacognitive adaptations?

The researchers will compare metacognitive therapy to a control condition without psychotherapy to see if metacognitive therapy is effective in treating OCD.

Participants will:

Receive the metacognitive therapy intervention or under control conditions for 8 to 15 weeks.

Be assessed for symptoms and metacognitive beliefs at pre-intervention, post-intervention and 12 weeks post-intervention

详细描述

This study will be a randomised controlled clinical trial. Participants who meet the enrolment criteria will be randomised into an experimental group and a control group. Participants in the experimental group will receive 8-15 weeks of metacognitive therapy, while participants in the control group will receive the same amount of time of regular treatment without psychotherapy components.

The researchers will assess participants' obsessive-compulsive symptoms and metacognitive levels before, after, and 12 weeks after the intervention. Assessment measures will be the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) and the Metacognition Questionnaire (MCQ-30).

By comparing the assessment results of the two groups of participants, conclusions will be drawn as to whether metacognitive therapy can have a positive effect on a Chinese OCD sample.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor is a psychiatrist who was not involved in the randomization and treatment process.

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • two psychiatrists with the title of Deputy Chief Physician or above jointly determine that the above diagnostic criteria were met
  • education level of junior high school or above, without mental retardation or audio-visual disorders
  • participation in the study is voluntary, and the informed consent is signed by the patient or his/her guardian

排除标准

  • loss of or insufficient self-awareness, the presence of hallucinations, delusions, and other psychotic symptoms
  • the presence of severe depression, or self-inflicted suicidal attempts and behaviors
  • the presence of a history of alcohol or drug abuse
  • refusal of psychotherapy, or the ineffectiveness of those who had been involved in a full course of psychotherapy.

结局指标

主要结局

Severity of participants' obsessive-compulsive symptoms

时间窗: Pre-intervention to 12 weeks post-intervention

Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms.

次要结局

  • Levels of Participants' Dysfunctional Metacognitive Beliefs(Pre-intervention to 12 weeks post-intervention)

研究者

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

Fan Jiang

Clinical Professor

Northeast Normal University

研究点 (1)

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