Obsessive-Compulsive DisorderdMBT-OCDNCT07701616
Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder
A study testing Digital Mindfulness-Based Therapy and Routine Pharmacological Treatment in people with Obsessive-Compulsive Disorder, run by Central South University at 2 sites in China.
Trial summary
This randomized controlled trial aims to evaluate the effects of digital mindfulness-based therapy in people with obsessive-compulsive disorder and to explore its possible psychological and neurophysiological mechanisms. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Digital Mindfulness-Based Therapy and Routine Pharmacological Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jul 2026to 31 Oct 2028
- Phase
- Interventional
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A primary diagnosis of obsessive-compulsive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Aged 12 to 65 years.
- Primary school education or above and able to understand the study procedures and complete the required assessments.
- Willing and able to provide written informed consent. For participants under 18 years of age, written informed consent will also be obtained from a parent or legal guardian.
- Participants who are already receiving psychotropic medication must have maintained a stable medication regimen for at least 4 weeks before enrollment. Any clinically necessary medication changes during the study will be documented.
Who cannot join
- Current or lifetime diagnosis of schizophrenia spectrum disorder, bipolar disorder, substance use disorder, or personality disorder.
- Severe physical illness or central nervous system disease that may interfere with participation in the study.
- Severe suicidal ideation or suicidal behavior within the past month.
- Pregnancy, planned pregnancy, or breastfeeding.
- Concurrent participation in another psychotherapy program or clinical trial.
- Mindfulness practice within the past month.
- Inability to understand or comply with the study procedures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xuan Zhang contact
China2 sites, 2 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xuan Zhang, BS, +8619908483241, liekka1018@163.com
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Xuan Zhang, BS, +8619908483241, liekk1018@163.com
About this study
Official title: Effects and Neurophysiological Mechanisms of Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder
This randomized controlled trial aims to evaluate the effects of digital mindfulness-based therapy in people with obsessive-compulsive disorder and to explore its possible psychological and neurophysiological mechanisms.
A total of 150 participants with a primary diagnosis of obsessive-compulsive disorder will be randomly assigned in a 1:1:1 ratio to one of three groups: digital mindfulness-based therapy, routine pharmacological treatment, or digital mindfulness-based therapy combined with routine pharmacological treatment.
Read more
The digital mindfulness-based therapy program will last for 6 weeks and will be delivered through a mobile mini-program using structured video and audio lessons, guided mindfulness practices, supervised weekly learning, and home practice. Participants in the pharmacological treatment group will receive routine pharmacological treatment for obsessive-compulsive disorder, and participants in the combined group will receive both interventions.
Changes in obsessive-compulsive symptoms, mindfulness, emotional symptoms, and other psychological outcomes will be assessed during treatment and follow-up. Heart rate variability will be assessed at baseline and weekly during the 6-week intervention. Electroencephalography will be assessed at baseline, at the end of the 6-week intervention, and at the 3-month and 6-month follow-up assessments to explore neurophysiological changes associated with treatment.
Read the detailed description
Obsessive-compulsive disorder is a disabling psychiatric condition characterized by persistent obsessions, compulsions, or both. Although pharmacological treatment and cognitive behavioral interventions are effective for many patients, some individuals continue to experience residual symptoms, poor treatment adherence, limited access to psychotherapy, or difficulty tolerating intensive symptom-focused interventions.
Digital mindfulness-based therapy may provide a more accessible and standardized psychological intervention. The intervention used in this study is a 6-week structured program delivered through a mobile mini-program. It includes psychoeducation, guided video and audio lessons, mindfulness meditation practices, supervised weekly learning, and home practice. The course covers mindful breathing, body scan, mindful movement, awareness of thoughts and emotions, acceptance-based practices, and compassion-related exercises.
Eligible participants will be randomly assigned in a 1:1:1 ratio to digital mindfulness-based therapy, routine pharmacological treatment, or digital mindfulness-based therapy combined with routine pharmacological treatment. Clinical and psychological assessments will be conducted at baseline, weekly during the 6-week intervention, and at 1, 3, 6, and 12 months after the intervention.
The primary clinical outcome will be the change in obsessive-compulsive symptom severity measured using the Yale-Brown Obsessive Compulsive Scale from baseline to the end of the 6-week intervention. Repeated assessments during treatment and follow-up will be used to examine symptom trajectories and the maintenance of treatment effects. Secondary psychological outcomes will include changes in mindfulness, thought-action fusion, self-compassion, depression, anxiety, and other related psychological characteristics.
Heart rate variability will be assessed at baseline and weekly during the 6-week intervention using time-domain, frequency-domain, and nonlinear measures to examine changes in autonomic nervous system regulation. Electroencephalography will be collected at baseline, at the end of the 6-week intervention, and at the 3-month and 6-month follow-up assessments. Electroencephalographic measures will include the mean amplitude and latency of the N200 and P300 event-related potential components. These measures will be used to explore psychological and neurophysiological mechanisms associated with improvement in obsessive-compulsive symptoms.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Digital Mindfulness-Based Therapy, Routine Pharmacological Treatment
- Keywords
- Mindfulness, Digital Mindfulness-Based Therapy, Digital Intervention, Electroencephalography, Obsessive-Compulsive Symptoms
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Mindfulness-Based TherapyBehavioural
Also called dMBT
A 6-week structured digital mindfulness-based therapy program delivered through a mobile mini-program. The program includes psychoeducation, guided video and audio lessons, mindfulness meditation practices, supervised weekly learning, and home practice. The course covers mindful breathing, body scan, mindful movement, awareness of thoughts and emotions, acceptance-based practices, and compassion-related exercises.
Routine Pharmacological TreatmentDrug
Participants will receive routine pharmacological treatment for obsessive-compulsive disorder according to clinical evaluation and standard psychiatric practice. Medication type and dosage will be determined by the treating psychiatrist and recorded throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Digital Mindfulness-Based Therapy | Experimental | Participants assigned to this arm will receive a 6-week digital mindfulness-based therapy program delivered through a mobile mini-program. The intervention includes structured video and audio lessons, guided mindfulness practices, supervised weekly learning, and home practice. Receives: Behavioral: Digital Mindfulness-Based Therapy |
| Routine Pharmacological Treatment | Active comparator | Participants assigned to this arm will receive routine pharmacological treatment for obsessive-compulsive disorder as determined by the treating psychiatrist. Receives: Drug: Routine Pharmacological Treatment |
| Digital Mindfulness-Based Therapy Plus Routine Pharmacological Treatment | Experimental | Participants assigned to this arm will receive both the 6-week digital mindfulness-based therapy program and routine pharmacological treatment for obsessive-compulsive disorder. Receives: Behavioral: Digital Mindfulness-Based Therapy; Drug: Routine Pharmacological Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive Compulsive Scale Total Score
The Yale-Brown Obsessive Compulsive Scale is a clinician-administered scale used to assess the severity of obsessive-compulsive symptoms. It consists of 10 items assessing obsessions and compulsions. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity. The primary outcome is the change in total score from baseline to the end of the 6-week intervention.
Measured: Baseline and week 6
Secondary outcomes (5)
Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up
The Yale-Brown Obsessive Compulsive Scale is a 10-item clinician-administered measure of obsessive-compulsive symptom severity. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 40. Higher total scores indicate more severe obsessive-compulsive symptoms and therefore represent a worse outcome. Changes from baseline will be assessed weekly during the 6-week intervention and at follow-up assessments to evaluate symptom trajectories and the maintenance of treatment effects.
Measured: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Five Facet Mindfulness Questionnaire Total and Subscale Scores
The Five Facet Mindfulness Questionnaire is a 39-item self-report measure assessing five dimensions of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Each item is scored from 1 to 5. The total score ranges from 39 to 195, with higher total scores indicating higher levels of mindfulness and therefore representing a better outcome. Subscale scores range from 8 to 40 for observing, describing, acting with awareness, and nonjudging of inner experience, and from 7 to 35 for nonreactivity to inner experience. Changes from baseline will be assessed during treatment and follow-up.
Measured: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in State Mindfulness Scale Total Score
The State Mindfulness Scale is a 21-item self-report measure assessing mindful awareness of bodily sensations and mental events during a recent period. Each item is scored from 1 to 5, resulting in a total score ranging from 21 to 105. Higher total scores indicate higher levels of state mindfulness and therefore represent a better outcome. Changes from baseline will be assessed during treatment and follow-up.
Measured: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Heart Rate Variability
Heart rate variability will be assessed using time-domain, frequency-domain, and nonlinear indices, including the standard deviation of normal-to-normal intervals, root mean square of successive differences, high-frequency power, low-frequency power, the low-frequency to high-frequency power ratio, SD1, and SD2. Changes from baseline will be evaluated weekly during the 6-week intervention.
Measured: Baseline and weeks 1 through 6
Change in Electroencephalographic Event-Related Potential Measures
Electroencephalographic measures will include the mean amplitude and latency of the N200 and P300 event-related potential components. Changes from baseline will be evaluated at the end of the 6-week intervention and at the 3-month and 6-month follow-up assessments.
Measured: Baseline, week 6, and 3 and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Model description
- Eligible participants will be randomly assigned in a 1:1:1 ratio to digital mindfulness-based therapy, routine pharmacological treatment, or digital mindfulness-based therapy combined with routine pharmacological treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Chen Pan, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701616
- Sponsor's protocol ID
- OCD-dMBT-2025
- Other IDs
- Kuai25173
- Acronym
- dMBT-OCD
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the dataset contains sensitive clinical, psychological, and neurophysiological information, and the informed consent and ethics approval do not currently include provisions for public sharing of participant-level data. Deidentified aggregate data may be made available from the principal investigator upon reasonable request, subject to ethical approval and institutional data protection requirements.