Shanghai mental health center
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
Recruiting
NCT Number: NCT07484750
Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD
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.
Recruiting
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Conditions
Age range
16 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
mindfulness based exposure therapy
BehavioralMindfulness-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.
Treatment as usual (TAU)
Othertreatment as usual with stable medication
Primary outcomes
-
Obsessive-compulsive symptoms improvement
Time frame: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Mental Health Center
Other
Registry information
Official study title
Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2029
- First posted
- Mar 20, 2026
- Registry last updated
- Mar 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.