Metacognitive Therapy for Obsessive-Compulsive Disorder (MCTOCD)

The Efficacy of Metacognitive Therapy for Obsessive-compulsive Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Metacognitive Therapy; Other: General mental health promotion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fan Jiang, Ph.D; Phone Number: +86 13943004788; Email: Jiangf581@nenu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 0431
      • Recruiting
      • Northeast Normal University
      • Contact: Fan Jiang, Ph.D; Phone Number: +86 13943004788; Email: Jiangf581@nenu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metacognitive Therapy; Intervention using metacognitive therapy, with sessions set for 8-15 weeks of 1-2 weekly psychotherapeutic dialogue.	Behavioral: Metacognitive Therapy; A one-on-one face-to-face dialogue format will be used to conduct psychotherapy with each participant, and the treatment protocol will be based on the treatment manual for metacognitive therapy.
Placebo Comparator: Control Condition; Do not receive any additional psychotherapy in addition to conventional treatment.	Other: General mental health promotion; A general mental health mission will be conducted, not covering any metacognitive therapy related content, set for 8-15 weeks, 1 time per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of participants' obsessive-compulsive symptoms	Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms.	Pre-intervention to 12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Participants' Dysfunctional Metacognitive Beliefs	Assessed using the Metacognition Questionnaire (MCQ-30), with higher scores being associated with more dysfunctional metacognition.	Pre-intervention to 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: Northeast Normal University
• Investigators: Study Director: Xiaoming Liu, Ph.D, Northeast Normal University

Publications and helpful links

General Publications

• Fisher PL, Wells A. Metacognitive therapy for obsessive-compulsive disorder: a case series. J Behav Ther Exp Psychiatry. 2008 Jun;39(2):117-32. doi: 10.1016/j.jbtep.2006.12.001. Epub 2007 Mar 7.
• Wells A, Capobianco L, Matthews G, Nordahl HM. Editorial: Metacognitive Therapy: Science and Practice of a Paradigm. Front Psychol. 2020 Sep 18;11:576210. doi: 10.3389/fpsyg.2020.576210. eCollection 2020. No abstract available.

Helpful Links

• It contains the basic concepts of metacognitive therapy
• It contains a specific intervention process for metacognitive therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Obsessive-Compulsive Disorder; Metacognitive Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: NENU2023032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data might be made available to experts in the field upon request and upon the detailed description of the reason of request.
• IPD Sharing Time Frame: Access to data is expected to be open by 31 January 2025 and will always be continuous.
• IPD Sharing Access Criteria: Data will be made available to experts in the field upon request and upon the detailed description of the reason of request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No