Clinical trial NCT06466057: Metacognitive Therapy for Obsessive-Compulsive Disorder
Official title: The Efficacy of Metacognitive Therapy for Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Metacognitive Therapy
Lead sponsor: Northeast Normal University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of participants' obsessive-compulsive symptoms
timeFrame: Pre-intervention to 12 weeks post-intervention
Secondary outcomes:
measure: Levels of Participants' Dysfunctional Metacognitive Beliefs
timeFrame: Pre-intervention to 12 weeks post-intervention
Other outcomes:
Locations:
city: Changchun
country: China
facility: Northeast Normal University
state: Jilin
Study officials:
affiliation: Northeast Normal University
name: Xiaoming Liu, Ph.D
role: STUDY_DIRECTOR
References:
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.
citation: 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.