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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06466057
Other study ID # NENU2023032
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2024
Est. completion date November 1, 2024

Study information

Verified date June 2024
Source Northeast Normal University
Contact Fan Jiang, Ph.D
Phone 13943004788
Email Jiangf581@nenu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
China Northeast Normal University Changchun Jilin

Sponsors (1)

Lead Sponsor Collaborator
Northeast Normal University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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