Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder (dMBT-OCD)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chen Pan, Dr
- 電話番号：86-0731-88618487
- メール：758933968@qq.com
研究連絡先のバックアップ
- 名前：Xuan Zhang
- メール：liekka1018@163.com
研究場所
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Hunan
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Changsha、Hunan、中国
- 募集
- The Second Xiangya Hospital of Central South University
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コンタクト：
- Xuan Zhang, BS
- 電話番号：+8619908483241
- メール：liekka1018@163.com
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Changsha、Hunan、中国
- 募集
- The Third Xiangya Hospital of Central South University
-
コンタクト：
- Xuan Zhang, BS
- 電話番号：+8619908483241
- メール：liekk1018@163.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
他の名前：
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アクティブコンパレータ：Routine Pharmacological Treatment
Participants assigned to this arm will receive routine pharmacological treatment for obsessive-compulsive disorder as determined by the treating psychiatrist.
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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.
|
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実験的：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.
|
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.
他の名前：
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Yale-Brown Obsessive Compulsive Scale Total Score
時間枠：Baseline and week 6
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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.
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Baseline and week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Heart Rate Variability
時間枠：Baseline and weeks 1 through 6
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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.
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Baseline and weeks 1 through 6
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Change in Electroencephalographic Event-Related Potential Measures
時間枠：Baseline, week 6, and 3 and 6 months after the intervention
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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.
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Baseline, week 6, and 3 and 6 months after the intervention
|
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Change in Yale-Brown Obsessive Compulsive Scale Total Score During Treatment and Follow-up
時間枠：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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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Change in Five Facet Mindfulness Questionnaire Total and Subscale Scores
時間枠：Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
|
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Change in State Mindfulness Scale Total Score
時間枠：Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Beck Depression Inventory-Ⅱ Total Score
時間枠：Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
|
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Change in State Anxiety Inventory Score
時間枠：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
|
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Change in Thought-Action Fusion Scale Total Score
時間枠：Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
|
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Change in Self-Compassion Scale-Short Form Mean Score
時間枠：Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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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.
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Baseline, weeks 1 through 6, and 1, 3, 6, and 12 months after the intervention
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- OCD-dMBT-2025
- Kuai25173 (その他の識別子：CentralSouthU)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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米国FDA規制機器製品の研究
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強迫性障害の臨床試験
Digital Mindfulness-Based Therapyの臨床試験
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Barcelona Institute for Global Health完了