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Recruiting NCT07484750

Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD

No phase Interventional Obessive-Compulsive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mindfulness based exposure therapy, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Obessive-Compulsive Disorder. Basic parameters: 16 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial

Overview

Obessive-Compulsive Disorder (OCD) is frequently treatment-refractory and imposes a substantial burden on affected individuals. Although Exposure and Response Prevention (ERP) is widely regarded as the first-line intervention, its inherently distressing nature contributes to treatment refusal and premature dropout in a subset of patients. The present study aims to develop and validate a novel intervention, Mindfulness-Based Exposure Therapy (MBET). In contrast to existing protocols that incorporate mindfulness as an adjunct to ERP and have yielded mixed or limited benefits, this study seeks a theoretically grounded integration of mindfulness and exposure-based principles. We hypothesize that mindfulness training improves emotion regulation, thereby producing a synergistic effect that enhances patients' capacity to engage in and complete exposure tasks. From a clinical perspective, MBET is intended to offer a more tolerable and acceptable alternative to standard ERP, with the potential to improve treatment adherence and clinical outcomes among patients who experience traditional exposure procedures as excessively distressing.

Interventions

  • Behavioral mindfulness based exposure therapy
    Mindfulness-Based Exposure Therapy (MBET) is a structured, 10-week group psychological intervention specifically designed for individuals with Obsessive-Compulsive Disorder (OCD). The program is delivered in weekly sessions, with each session lasting 3 hours. To ensure optimal group dynamics and personalized attention, each group consists of 6 to 8 patients and is facilitated by 1 to 2 trained therapists.To reinforce the skills acquired during the group meetings, participants are assigned daily
  • Other Treatment as Usual (TAU)
    treatment as usual with stable medication

Primary outcome measures

  • Obsessive-compulsive symptoms improvement [Time frame: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).]

Eligibility criteria

Inclusion criteria

  • Have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
  • Are between 16 and 55 years of age (inclusive)
  • Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥ 16
  • Have an education level of junior high school or above
  • Are medication-free or have been stabilized on psychotropic medication for at least 8 weeks
  • Have sufficient visual and auditory capabilities to complete study assessments
  • Are willing to participate and provide written informed consent

Exclusion criteria

  • Meet DSM-5 criteria for any other psychiatric disorder besides OCD
  • Have severe OCD symptoms that prevent completion of assessments
  • Exhibit active suicidal ideation or high suicide risk
  • Have a serious somatic disease, central nervous system disease, or substance abuse history
  • Are pregnant, breastfeeding, or planning pregnancy
  • Have metal implants contraindicated for MRI (e.g., pacemakers, intracranial clips, metal dentures, arterial stents, joint fixations)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai mental health center — Shanghai

Identifiers

NCT: NCT07484750 · SMHC-OCD-019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗