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Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder

NCT07701616 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-20

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Second Xiangya Hospital of Central South University

    collaborator OTHER

  • Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-09-01
Completion
2028-10-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701616 on ClinicalTrials.gov