Obessive-Compulsive DisorderNCT07484750
Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD
A study testing mindfulness based exposure therapy and Treatment as Usual (TAU) in people with Obessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Obessive-Compulsive Disorder
- What is being tested?
- mindfulness based exposure therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai mental health center
Shanghai, Shanghai Municipality, 200030
Zhen Wang, 18017311286, wangzhen@smhc.org.cn
About this study
Official title: 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.
- Conditions
- Obessive-Compulsive Disorder
- Being tested
- mindfulness based exposure therapy, Treatment as Usual (TAU)
- Keywords
- mindfulness, Exposure and Response Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based exposure therapyBehavioural
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 with stable medication
| Study group | Role | What they receive |
|---|---|---|
| Experimental : active treatment group | Experimental | Not described Receives: Behavioral: mindfulness based exposure therapy |
| Treatment as usual group | Active comparator | Not described Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start3 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484750
- Sponsor's protocol ID
- SMHC-OCD-019
- Status last verified
- Feb 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07484750
- Acronym / sponsor ID
- SMHC-OCD-019
- Conditions
- Obessive-Compulsive Disorder
- Keywords
- mindfulness, Exposure and Response Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : active treatment group | Experimental | Behavioral: mindfulness based exposure therapy |
| Treatment as usual group | Active comparator | Other: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness based exposure therapyMindfulness-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. | Behavioural | Experimental : active treatment group |
| Treatment as Usual (TAU)treatment as usual with stable medication | Other | Treatment as usual group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness based exposure therapy and Treatment as Usual (TAU) in people with Obessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, MD (+8618017311286, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive symptoms improvement (time frame: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.