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Systematic development and efficacy validation of digital mindful cognitive therapy (dMBCT-I) for patients with chronic insomnia

Systematic development and efficacy validation of digital mindful cognitive therapy (dMBCT-I) for patients with chronic insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098744
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Digital mindfulness-based cognitive therapy group:Human-computer interactive digital mindfulness cognitive therapy
Online mindfulness-based cognitive therapy group:Therapist-led online group mindfulness-based cognitive therapy

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years old; 2. Meet the diagnostic criteria for chronic insomnia disorder in DSM-5, specifically: Difficulty falling asleep or maintaining sleep: sleep onset latency (SOL) and/or wakefulness of more than 30 minutes in the middle of sleep, > = 3 nights of sleep less than 6.5 hours per week; Duration>=3 months; Severe impairment of daytime function; 3. There is no communication and cognitive impairment, and basic operation of smart phones can be carried out; 4. For those who regularly use sleep medications, they need to stop taking sleep drugs for at least 2 weeks before participating in the study or agree to keep the dosage and frequency of sleep aid drugs unchanged during the study; 5. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a potentially life-threatening illness (e.g., suicidal tendencies, terminal cancer, etc.) or anticipate a situation that may seriously affect participation or compliance (e.g., pregnancy, dementia, substance abuse, etc.); 2. Presence of other physical diseases related to the onset and/or course of insomnia; 3. Patients diagnosed with depressive disorders, anxiety disorders, eating disorders, and substance abuse; 4. Patients with psychiatric symptoms or other mental disorder diagnoses; 5. Night shift work or other work/study tasks or living habits that affect sleep rhythm; 6. Those who have been using or plan to use MBCT/CBT; 7. Other sleep disorders, such as sleep apnea syndrome, periodic limb movement disorder, restless legs syndrome, REM sleep behavior disorder, narcolepsy, etc.; 8. Other researchers do not consider it eligible for inclusion.

Design outcomes

Primary

MeasureTime frame
Insomnia;

Secondary

MeasureTime frame
Hyperarousal;Sleep;depression;Anxiety;Five Facet Mindfulness Questionnaire;12-item Short Form Health Survey Version 2;Sleep diary;Actigraphy;

Countries

China

Contacts

Public ContactLei Huang

Shanghai Tongji Hospital

huanglei@tongji.edu.cn+86 185 2107 0332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026