Metacognitive Therapy for Obsessive-Compulsive Disorder

NCT ID: NCT06466057

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2024-11-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Metacognitive Therapy

Intervention using metacognitive therapy, with sessions set for 8-15 weeks of 1-2 weekly psychotherapeutic dialogue.

Group Type EXPERIMENTAL

Metacognitive Therapy

Intervention Type BEHAVIORAL

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.

Control Condition

Do not receive any additional psychotherapy in addition to conventional treatment.

Group Type PLACEBO_COMPARATOR

General mental health promotion

Intervention Type OTHER

A general mental health mission will be conducted, not covering any metacognitive therapy related content, set for 8-15 weeks, 1 time per week

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northeast Normal University

OTHER

Sponsor Role lead

Responsible Party

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Fan Jiang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoming Liu, Ph.D

Role: STUDY_DIRECTOR

Northeast Normal University

Locations

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Northeast Normal University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fan Jiang, Ph.D

Role: CONTACT

13943004788 ext. +86

Facility Contacts

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Fan Jiang, Ph.D

Role: primary

13943004788 ext. +86

References

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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.

Reference Type BACKGROUND
PMID: 33041948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17418090 (View on PubMed)

Related Links

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Other Identifiers

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NENU2023032

Identifier Type: -

Identifier Source: org_study_id

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