Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder

Sponsor
Central South University
Study ID
NCT07701616
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Change in Yale-Brown Obsessive Compulsive Scale Total Score [ Time Frame: Baseline and week 6 ]

Central Contacts

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