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

NCT07484750 | Recruiting

• 1 other identifier: SMHC-OCD-019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obessive-Compulsive Disorder

Keywords

mindfulness; Exposure and Response Prevention

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Experimental : active treatment group

EXPERIMENTAL

Behavioral: mindfulness based exposure therapy

Treatment as usual group

ACTIVE COMPARATOR

Other: Treatment as Usual (TAU)

Interventions

mindfulness based exposure therapy BEHAVIORAL

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.

Experimental : active treatment group

Treatment as Usual (TAU) OTHER

treatment as usual with stable medication

Treatment as usual group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai mental health center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Zhen Wang, MD

CONTACT

+8618017311286; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai mental health center

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)