Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-65
SponsorCentral South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Mindfulness-Based Therapy
BehavioralA 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
DrugParticipants 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Digital Mindfulness-Based TherapyExperimental treatment 1 intervention
Group B: Routine Pharmacological TreatmentActive comparator 1 intervention
Group C: Digital Mindfulness-Based Therapy Plus Routine Pharmacological TreatmentExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline and week 6Secondary outcomes
1
Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention2
Change in Five Facet Mindfulness Questionnaire Total and Subscale Scores
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention3
Change in State Mindfulness Scale Total Score
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention4
Change in Heart Rate Variability
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.
Time frame
Baseline and weeks 1 through 6Other outcomes
1
Change in Beck Depression Inventory-Ⅱ Total Score
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention2
Change in State Anxiety Inventory Score
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention3
Change in Thought-Action Fusion Scale Total Score
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention4
Change in Self-Compassion Scale-Short Form Mean Score
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.
Time frame
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Central South University
Lead sponsor
The Third Xiangya Hospital of Central South University
Sponsor institution
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov