Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder
Recruiting · NCT07701616 · Interventional (participants receive a specific treatment) · Lead sponsor: Central South University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- The Second Xiangya Hospital of Central South University - Changsha, Hunan, China
- The Third Xiangya Hospital of Central South University - Changsha, Hunan, China