Metacognitive Therapy for Obsessive-Compulsive Disorder

NCT06466057 | Recruiting

• 1 other identifier: NENU2023032
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Metacognitive Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of Participants' Dysfunctional Metacognitive Beliefs

  Pre-intervention to 12 weeks post-intervention

Study Arms (2)

Metacognitive Therapy

EXPERIMENTAL

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

Behavioral: Metacognitive Therapy

Control Condition

PLACEBO COMPARATOR

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

Other: General mental health promotion

Interventions

Metacognitive Therapy 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.

Metacognitive Therapy

General mental health promotion 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

Control Condition

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northeast Normal University: lead

Study Sites (1)

Northeast Normal University

Changchun, Jilin, 0431, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33041948 BACKGROUND

• 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.

  PMID: 17418090 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Xiaoming Liu, Ph.D

  Northeast Normal University

  STUDY DIRECTOR

Central Study Contacts

Fan Jiang, Ph.D

CONTACT

13943004788; Jiangf581@nenu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is a psychiatrist who was not involved in the randomization and treatment process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: June 11, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Access to data is expected to be open by 31 January 2025 and will always be continuous.
• Access Criteria: Data will be made available to experts in the field upon request and upon the detailed description of the reason of request.

Locations

CN (1)