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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-55
SponsorShanghai Mental Health Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Treatment as Usual (TAU)

    Other intervention

    treatment as usual with stable medication

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Experimental : active treatment groupExperimental treatment 1 intervention
Group B: Treatment as usual groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).

Secondary outcomes

Other outcomes

Sponsors and contacts

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