Obsessive-Compulsive DisorderMCTOCDNCT06466057
Metacognitive Therapy for Obsessive-Compulsive Disorder
A study testing Metacognitive Therapy and General mental health promotion in people with Obsessive-Compulsive Disorder, run by Northeast Normal University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Metacognitive Therapy and General mental health promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Northeast Normal University
Changchun, Jilin, 0431
Fan Jiang, Ph.D, 13943004788 ext. +86, Jiangf581@nenu.edu.cn
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Metacognitive Therapy, General mental health promotion
- Keywords
- Obsessive-Compulsive Disorder, Metacognitive Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyBehavioural
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.
General mental health promotionOther
A general mental health mission will be conducted, not covering any metacognitive therapy related content, set for 8-15 weeks, 1 time per week
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Therapy | Experimental | Intervention using metacognitive therapy, with sessions set for 8-15 weeks of 1-2 weekly psychotherapeutic dialogue. Receives: Behavioral: Metacognitive Therapy |
| Control Condition | Placebo comparator | Do not receive any additional psychotherapy in addition to conventional treatment. Receives: Other: General mental health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of participants' obsessive-compulsive symptoms
Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms.
Measured: Pre-intervention to 12 weeks post-intervention
Secondary outcomes (1)
Levels of Participants' Dysfunctional Metacognitive Beliefs
Assessed using the Metacognition Questionnaire (MCQ-30), with higher scores being associated with more dysfunctional metacognition.
Measured: Pre-intervention to 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start11 Jun 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Jiang, Northeast Normal University
- Investigators
- Xiaoming Liu, Ph.D, Study director, Northeast Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466057
- Sponsor's protocol ID
- NENU2023032
- Acronym
- MCTOCD
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data might be made available to experts in the field upon request and upon the detailed description of the reason of request.
Publications
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.
PubMed 33041948Fisher 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.
PubMed 17418090
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Metacognitive Therapy for Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06466057
- Acronym / sponsor ID
- MCTOCD / NENU2023032
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Metacognitive Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Behavioral: Metacognitive TherapyIntervention using metacognitive therapy, with sessions set for 8-15 weeks of 1-2 weekly psychotherapeutic dialogue. |
| Control Condition | Placebo comparator | Other: General mental health promotionDo not receive any additional psychotherapy in addition to conventional treatment. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TherapyA 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. | Behavioural | Metacognitive Therapy |
| General mental health promotionA general mental health mission will be conducted, not covering any metacognitive therapy related content, set for 8-15 weeks, 1 time per week | Other | Control Condition |
Primary outcome
Severity of participants' obsessive-compulsive symptoms
Time frame: Pre-intervention to 12 weeks post-intervention
Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms.
1 secondary outcome
Levels of Participants' Dysfunctional Metacognitive Beliefs
Time frame: Pre-intervention to 12 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 33041948Wells 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.
- Background: PubMed 17418090Fisher 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.
- It contains the basic concepts of metacognitive therapyLink provided by the sponsor.
- It contains a specific intervention process for metacognitive therapyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data might be made available to experts in the field upon request and upon the detailed description of the reason of request.
Related trials for Obsessive-Compulsive Disorder
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Liu, Ph.D study director
Northeast Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy and General mental health promotion in people with Obsessive-Compulsive Disorder, run by Northeast Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Jiang, Ph.D (13943004788 ext. +86, Jiangf581@nenu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of participants' obsessive-compulsive symptoms (time frame: Pre-intervention to 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466057, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.