Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder

NCT07701616 | Recruiting

• 2 other identifiers: OCD-dMBT-2025Kuai25173
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Mindfulness; Digital Mindfulness-Based Therapy; Digital Intervention; Electroencephalography; Obsessive-Compulsive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 6

Secondary Outcomes (5)

• Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up

  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

  Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

• Change in State Mindfulness Scale Total Score

  Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

• Change in Heart Rate Variability

  Baseline and weeks 1 through 6

• Change in Electroencephalographic Event-Related Potential Measures

  Baseline, week 6, and 3 and 6 months after the intervention

Other Outcomes (4)

• Change in Beck Depression Inventory-Ⅱ Total Score

  Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

• Change in State Anxiety Inventory Score

  Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

• Change in Thought-Action Fusion Scale Total Score

  Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

Study Arms (3)

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.

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.

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.

Behavioral: Digital Mindfulness-Based Therapy; Drug: Routine Pharmacological Treatment

Interventions

Digital Mindfulness-Based Therapy BEHAVIORAL

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.

Also known as: dMBT

Digital Mindfulness-Based Therapy; Digital Mindfulness-Based Therapy Plus Routine Pharmacological Treatment

Routine Pharmacological Treatment DRUG

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.

Digital Mindfulness-Based Therapy Plus Routine Pharmacological Treatment; Routine Pharmacological Treatment

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (2)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Chen Pan, Dr

CONTACT

86-0731-88618487; 758933968@qq.com

Xuan Zhang

CONTACT

liekka1018@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the psychological and behavioral intervention, participants and intervention providers cannot be blinded to treatment allocation. Clinical outcome assessments will be conducted by trained assessors who are independent of intervention delivery and blinded to group assignment. Participants will be instructed not to disclose their treatment allocation to the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)