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Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder (dMBT-OCD)

17. juli 2026 opdateret af: Chen Pan, Central South University

Effects and Neurophysiological Mechanisms of Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Obsessive-compulsive disorder is a disabling psychiatric condition characterized by persistent obsessions, compulsions, or both. Although pharmacological treatment and cognitive behavioral interventions are effective for many patients, some individuals continue to experience residual symptoms, poor treatment adherence, limited access to psychotherapy, or difficulty tolerating intensive symptom-focused interventions.

Digital mindfulness-based therapy may provide a more accessible and standardized psychological intervention. The intervention used in this study is a 6-week structured program delivered through a mobile mini-program. It 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.

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. Clinical and psychological assessments will be conducted at baseline, weekly during the 6-week intervention, and at 1, 3, 6, and 12 months after the intervention.

The primary clinical outcome will be the change in obsessive-compulsive symptom severity measured using the Yale-Brown Obsessive Compulsive Scale from baseline to the end of the 6-week intervention. Repeated assessments during treatment and follow-up will be used to examine symptom trajectories and the maintenance of treatment effects. Secondary psychological outcomes will include changes in mindfulness, thought-action fusion, self-compassion, depression, anxiety, and other related psychological characteristics.

Heart rate variability will be assessed at baseline and weekly during the 6-week intervention using time-domain, frequency-domain, and nonlinear measures to examine changes in autonomic nervous system regulation. Electroencephalography will be collected at baseline, at the end of the 6-week intervention, and at the 3-month and 6-month follow-up assessments. Electroencephalographic measures will include the mean amplitude and latency of the N200 and P300 event-related potential components. These measures will be used to explore psychological and neurophysiological mechanisms associated with improvement in obsessive-compulsive symptoms.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Hunan
      • Changsha, Hunan, Kina
        • Rekruttering
        • The Second Xiangya Hospital of Central South University
        • Kontakt:
      • Changsha, Hunan, Kina
        • Rekruttering
        • The Third Xiangya Hospital of Central South University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. A primary diagnosis of obsessive-compulsive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  2. Aged 12 to 65 years.
  3. Primary school education or above and able to understand the study procedures and complete the required assessments.
  4. 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.
  5. 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:

  1. Current or lifetime diagnosis of schizophrenia spectrum disorder, bipolar disorder, substance use disorder, or personality disorder.
  2. Severe physical illness or central nervous system disease that may interfere with participation in the study.
  3. Severe suicidal ideation or suicidal behavior within the past month.
  4. Pregnancy, planned pregnancy, or breastfeeding.
  5. Concurrent participation in another psychotherapy program or clinical trial.
  6. Mindfulness practice within the past month.
  7. Inability to understand or comply with the study procedures.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • dMBT
Aktiv komparator: Routine Pharmacological Treatment
Participants assigned to this arm will receive routine pharmacological treatment for obsessive-compulsive disorder as determined by the treating psychiatrist.
Medicin: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • dMBT
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Yale-Brown Obsessive Compulsive Scale Total Score
Tidsramme: Baseline and week 6
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Heart Rate Variability
Tidsramme: Baseline and weeks 1 through 6
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.
Baseline and weeks 1 through 6
Change in Electroencephalographic Event-Related Potential Measures
Tidsramme: Baseline, week 6, and 3 and 6 months after the intervention
Electroencephalographic measures will include the mean amplitude and latency of the N200 and P300 event-related potential components. Changes from baseline will be evaluated at the end of the 6-week intervention and at the 3-month and 6-month follow-up assessments.
Baseline, week 6, and 3 and 6 months after the intervention
Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
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
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in State Mindfulness Scale Total Score
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Beck Depression Inventory-Ⅱ Total Score
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in State Anxiety Inventory Score
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Thought-Action Fusion Scale Total Score
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
Change in Self-Compassion Scale-Short Form Mean Score
Tidsramme: Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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.
Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Central South University

Samarbejdspartnere

Second Xiangya Hospital of Central South University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

31. oktober 2028

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OCD-dMBT-2025
  • Kuai25173 (Anden identifikator: CentralSouthU)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be made publicly available because the dataset contains sensitive clinical, psychological, and neurophysiological information, and the informed consent and ethics approval do not currently include provisions for public sharing of participant-level data. Deidentified aggregate data may be made available from the principal investigator upon reasonable request, subject to ethical approval and institutional data protection requirements.

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