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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: mindfulness based exposure therapy; Other: Treatment as Usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Wang, MD; Phone Number: +8618017311286; Email: wangzhen@smhc.org.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Zhen Wang; Phone Number: 18017311286; Email: wangzhen@smhc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental : active treatment group	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 homework at the end of each session, which requires 30 to 60 minutes of independent practice per day. At its core, the treatment process features a deep integration of mindfulness and Exposure and Response Prevention (ERP). Rather than treating these as separate components, MBET seamlessly embeds the core philosophies and practices of mindfulness directly into the ERP exercises, allowing patients to apply mindful awareness and acceptance while actively confronting their obsessional triggers.
Active Comparator: Treatment as usual group	Other: Treatment as Usual (TAU); treatment as usual with stable medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive-compulsive symptoms improvement	The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.	Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: mindfulness; Exposure and Response Prevention
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: SMHC-OCD-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No