Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder (dMBT-OCD)

July 17, 2026 updated by: Chen Pan, Central South University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. A primary diagnosis of obsessive-compulsive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  2. Aged 12 to 65 years.
  3. Primary school education or above and able to understand the study procedures and complete the required assessments.
  4. 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.
  5. 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.

Exclusion Criteria:

  1. Current or lifetime diagnosis of schizophrenia spectrum disorder, bipolar disorder, substance use disorder, or personality disorder.
  2. Severe physical illness or central nervous system disease that may interfere with participation in the study.
  3. Severe suicidal ideation or suicidal behavior within the past month.
  4. Pregnancy, planned pregnancy, or breastfeeding.
  5. Concurrent participation in another psychotherapy program or clinical trial.
  6. Mindfulness practice within the past month.
  7. Inability to understand or comply with the study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital Mindfulness-Based Therapy
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.
Behavioral: Digital Mindfulness-Based Therapy
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.
Other Names:
  • dMBT
Active Comparator: Routine Pharmacological Treatment
Participants assigned to this arm will receive routine pharmacological treatment for obsessive-compulsive disorder as determined by the treating psychiatrist.
Drug: Routine Pharmacological Treatment
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.
Experimental: Digital Mindfulness-Based Therapy Plus Routine Pharmacological Treatment
Participants assigned to this arm will receive both the 6-week digital mindfulness-based therapy program and routine pharmacological treatment for obsessive-compulsive disorder.
Behavioral: Digital Mindfulness-Based Therapy
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.
Other Names:
  • dMBT
Drug: Routine Pharmacological Treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Yale-Brown Obsessive Compulsive Scale Total Score
Time Frame: Baseline and week 6
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.
Baseline and week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability
Time Frame: Baseline and weeks 1 through 6
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.
Baseline and weeks 1 through 6
Change in Electroencephalographic Event-Related Potential Measures
Time Frame: Baseline, week 6, and 3 and 6 months after the intervention
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.
Baseline, week 6, and 3 and 6 months after the intervention
Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
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
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in State Mindfulness Scale Total Score
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Beck Depression Inventory-Ⅱ Total Score
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
The Beck Depression Inventory-II is a 21-item self-report measure of depressive symptom severity. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 63. Higher total scores indicate greater depressive symptom severity and therefore represent a worse outcome. Changes from baseline will be assessed during treatment and follow-up.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in State Anxiety Inventory Score
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
The State subscale of the State-Trait Anxiety Inventory is a 20-item self-report measure assessing the current intensity of anxiety symptoms. Each item is scored from 1 to 4, resulting in a total score ranging from 20 to 80. Higher total scores indicate greater state anxiety and therefore represent a worse outcome. Changes from baseline will be assessed during treatment and follow-up.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Thought-Action Fusion Scale Total Score
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
The Thought-Action Fusion Scale is a 19-item self-report measure assessing beliefs that having an unacceptable thought increases the likelihood of a related event occurring or is morally equivalent to carrying out the corresponding action. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 76. Higher total scores indicate stronger thought-action fusion beliefs and therefore represent a worse outcome. Changes from baseline will be assessed during treatment and follow-up.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Self-Compassion Scale-Short Form Mean Score
Time Frame: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
The Self-Compassion Scale-Short Form is a 12-item self-report measure assessing self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification. Each item is scored from 1 to 5. After reverse-scoring the negatively worded items, the mean of the 12 items is calculated, resulting in a mean score ranging from 1 to 5. Higher mean scores indicate higher levels of self-compassion and therefore represent a better outcome. Changes from baseline will be assessed during treatment and follow-up.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OCD-dMBT-2025
  • Kuai25173 (Other Identifier: CentralSouthU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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