Exploring The Metacognitive Beliefs in OCD: A Randomized Controlled Trial of Metacognitive Therapy

NCT07052812 | Completed

• 1 other identifier: 2022035
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

Exploring The Metacognitive Beliefs in OCD: A Randomized Controlled Trial of Metacognitive Therapy Introduction Obsessive-Compulsive Disorder (OCD) is a mental health condition characterized by intrusive thoughts (obsessions) and repetitive behaviors (compulsions). These symptoms cause significant distress and impair daily functioning. OCD can be difficult to treat, and relapse rates are high even after conventional treatments. This study evaluates whether Metacognitive Therapy (MCT) is more effective than Treatment as Usual (TAU) in reducing OCD symptoms and improving overall well-being. The study explores how MCT, which targets metacognitive beliefs (thoughts about thoughts), can help manage symptoms more effectively than standard treatments. Study Goal and Research Question The primary goal of this study is to assess the effectiveness of Metacognitive Therapy (MCT) compared to Treatment as Usual (TAU) for treating Obsessive-Compulsive Disorder (OCD). The key research question is: Does Metacognitive Therapy (MCT) reduce OCD symptoms more effectively than Treatment as Usual (TAU)? Study Design This study is a Randomized Controlled Trial (RCT), which means participants are randomly assigned to one of two treatment groups: Metacognitive Therapy (MCT): Participants in this group receive a 12-session therapy program that focuses on addressing harmful metacognitive beliefs, such as the need to control thoughts and the belief that thoughts can cause harm. Treatment as Usual (TAU): Participants in this group receive the standard treatment for OCD, which may include Exposure and Response Prevention (ERP) and/or medication. Who Can Participate? Adults aged 18 and older who have been diagnosed with OCD are eligible to participate in the study. To be eligible, participants must have moderate to severe OCD symptoms, measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Individuals with severe mental health conditions other than OCD, such as psychosis or substance use disorders, are excluded from participation. Participants must also be able to attend therapy sessions and complete the necessary assessments throughout the study. How the Study Was Conducted Randomization: Participants were randomly assigned to either the MCT group or the TAU group. MCT Group: Participants in the MCT group attended 12 therapy sessions, which focused on changing metacognitive beliefs that contribute to OCD symptoms. TAU Group: Participants in the TAU group received standard treatment for OCD, which may have included a combination of therapy and medications. Assessments: Participants were assessed at three time points: before treatment (pre-treatment), immediately after treatment (post-treatment), and six months after treatment (follow-up). These assessments measured changes in OCD symptoms, metacognitive beliefs, and overall quality of life. Study Procedures and Timeline Pre-Treatment Assessment: Participants completed initial assessments to measure their OCD symptoms, metacognitive beliefs, and quality of life. Therapy Sessions: Participants in both groups attended their respective therapy sessions (12 sessions for MCT, standard sessions for TAU). Post-Treatment and Follow-Up Assessments: After the therapy ended, participants completed post-treatment assessments. Six months later, they participated in a follow-up assessment to measure the long-term effectiveness of the treatment. Important Information for Participants Metacognitive Therapy (MCT) is designed to help people change the way they think about their thoughts, addressing beliefs such as the need to control thoughts or the belief that having certain thoughts can cause harm. Treatment as Usual (TAU) is the standard treatment for OCD, which may include Exposure and Response Prevention (ERP) therapy or medication management. Participants in this study can withdraw at any time, and their decision will not affect their treatment or relationship with their healthcare provider. Expected Benefits If MCT is found to be more effective than TAU, it may offer a new, personalized approach to treating OCD, especially for individuals whose symptoms are driven by dysfunctional metacognitive beliefs. Additionally, since MCT targets the underlying thought processes that maintain OCD symptoms, it may provide longer-lasting symptom relief and reduce the likelihood of relapse compared to standard treatments. Study Impact This study will provide important insights into whether MCT can provide better outcomes for individuals with OCD compared to standard treatments. If MCT is shown to be effective, it could become a valuable treatment option for those who do not respond well to traditional therapies like ERP. Moreover, MCT's focus on addressing metacognitive beliefs may lead to more durable improvements in OCD symptoms.

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

Obsessive-Compulsive Disorder, Metacognitive Beliefs, Metacognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score

  The Y-BOCS is a 10-item clinician-rated scale (scores 0-40) measuring OCD symptom severity. Higher scores indicate worse symptoms. Assessed at baseline, post-treatment (week 12), and 6-month follow-up. Primary endpoint is baseline to week 12 change.

  Baseline, Week 12 (post-treatment), 6-month follow-up

Secondary Outcomes (2)

• Change in Metacognitions Questionnaire-30 (MCQ-30) total score

  Baseline, Week 12 (post-treatment), 6-month follow-up

• Change in WHOQOL-BREF global score

  Baseline, Week 12 (post-treatment), 6-month follow-up

Study Arms (2)

MCT

EXPERIMENTAL

Arm Description for "MCT" (Experimental Arm):\*\* "Participants receive 12 weekly sessions of manualized Metacognitive Therapy (MCT) for OCD, delivered by trained clinicians. The intervention targets maladaptive metacognitive beliefs (e.g., thought-action fusion) through: (1) Attention Training Technique, (2) Detached Mindfulness exercises, and (3) behavioral experiments to modify compulsions. Treatment progresses through four phases: psychoeducation, challenging perfectionism, addressing intolerance of uncertainty, and relapse prevention. Primary outcome: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Behavioral: MCT

TAU

ACTIVE COMPARATOR

Treatment as Usual (TAU) consists of 12-week standard outpatient care for OCD, including: * Psychoeducation about OCD symptoms. * Supportive counseling (stress management, coping strategies). * SSRI medication management (if prescribed). * Simplified exposure exercises (without formal ERP protocols). * Family involvement in care.

Behavioral: MCT

Interventions

MCT BEHAVIORAL

Metacognitive Therapy (MCT) is a 12-week manualized treatment for OCD targeting maladaptive thought patterns. Clinicians deliver structured sessions including: (1) Attention Training to modify focus, (2) Detached Mindfulness to change responses to intrusive thoughts, and (3) behavioral experiments to reduce compulsions. Treatment progresses through psychoeducation, challenging perfectionism, addressing thought control, and relapse prevention. Primary outcome: Y-BOCS; secondary: MCQ-30 and TFI. Based on the evidence-based myMCT protocol.

MCT; TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Primary DSM-5 diagnosis of OCD (confirmed by SCID-5) 2. Age 18-65 years 3. Y-BOCS score ≥16 (moderate-to-severe symptoms) 4. Stable medication regimen (no changes in past 6 weeks) 5. Fluent in Urdu or English 6. Willing to attend all sessions and assessments

You may not qualify if:

• \. Current psychotic, bipolar, or severe depressive disorder 2. Active substance use disorder requiring treatment 3. Intellectual disability or cognitive impairment 4. Concurrent psychotherapy for OCD 5. Recent medication changes (past 6 weeks) 6. Completed OCD-specific therapy in past 3 months

Sponsors & Collaborators

• Northeast Normal University: lead

Study Sites (2)

IOMH Institute of Mental Health

Islamabad, Punjab Province, 44320, Pakistan

Location

Subhan Medical Centre Trust

Islamabad, Punjab Province, 44320, Pakistan

Location

Related Publications (2)

• Moritz S, Jelinek L, Hauschildt M, Naber D. How to treat the untreated: effectiveness of a self-help metacognitive training program (myMCT) for obsessive-compulsive disorder. Dialogues Clin Neurosci. 2010;12(2):209-20. doi: 10.31887/DCNS.2010.12.2/smoritz.

  PMID: 20623925 BACKGROUND

• Philipp R, Kriston L, Lanio J, Kuhne F, Harter M, Moritz S, Meister R. Effectiveness of metacognitive interventions for mental disorders in adults-A systematic review and meta-analysis (METACOG). Clin Psychol Psychother. 2019 Mar;26(2):227-240. doi: 10.1002/cpp.2345. Epub 2018 Dec 16.

  PMID: 30456821 BACKGROUND

Related Links

• Official publication of the myMCT manual used in this trial'

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Dr Jiang Yingjie, PhD

  Northeast Normal University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Model Details: Parallel-Group Model Description:\*\* "This randomized controlled trial employed a two-arm parallel design comparing Metacognitive Therapy (MCT) with standard Treatment As Usual (TAU) for OCD. Participants (N=76) were equally allocated to either: (1) MCT - 12 weekly sessions targeting metacognitive beliefs about thoughts, or (2) TAU - routine care including medications and basic counseling with family involvement. Randomization used computer-generated blocks with allocation concealment. Both groups were assessed identically at baseline, post-treatment (week 12), and 6-month follow-up using Y-BOCS as the primary outcome. The parallel structure ensured no treatment crossover. TAU specifically included supportive counseling (not formal CBT) with family participation in care, reflecting real-world clinical practice in the study settings. Independent assessors, blinded to treatment assignment, conducted all evaluations.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: January 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 7, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)