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Effects of online group mindfulness-based cognitive therapy (MBCT-I) for chronic insomnia disorders, a randomized controlled clinical study

Effects of online group mindfulness-based cognitive therapy (MBCT-I) for chronic insomnia disorders, a randomized controlled clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084300
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

chronic insomnia

Interventions

Intervention group:8 week mindfulness-based cognitive therapy for insomnia (MBCT-I)
control group:Sleep hygiene education(SHE)

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Those aged between 18 and 65 years old; (2) having chronic insomnia based on DSM-5 diagnostic criteria that included: (a) difficulties initiating and/or maintaining sleep, defined as sleep onset latency (SOL) and/or wake time after sleep onset (WASO) greater than 30 minutes, with sleep duration of less than 6.5 hours on at least 3 nights per week; (b) duration exceeding 3 months; (c) severe impairment of daytime functioning; (3) Normal speech and cognitive function, Montreal cognitive assessment score of ?23; (4) being willing to participate in the online MBCT-I or SHE; (5) agree to maintain the dosage and frequency of sleep medication throughout the study or discontinue usage for at least 2 weeks (washout period) prior to study enrollment among those who use sleep medication regularly; (6) voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Illiterate individuals as they might be unable to complete sleep diaries and questionnaire assessments; (2) individuals with life-threatening conditions (e.g. suicidal ideation, advanced cancer) or expected to experience circumstances that may severely affect compliance (e.g. pregnancy, dementia, substance abuse); (3) Presence of progressive medical illnesses related to the onset and/or course of insomnia; (4) individuals previously diagnosed with or currently suspected to have schizophrenia, major depressive disorders, anxiety disorders, eating disorders or substance abuse; (5)Patients with psychiatric symptoms or other psychiatric disorder diagnoses; (6) having night shift work; (7) those have already received MBCT or CBT or SHE; (8) reporting other sleep disorders (e.g. sleep apnea, periodic limb movement disorder, restless leg syndrome, rapid eye movement sleep behavior disorder and hypersomina).

Design outcomes

Primary

MeasureTime frame
insomnia severity inventory;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Complex Sleep Variables;Sleep Perception Index;Patient Health Questionaire-9;Generalized anxiety disorder-7;Mindfulness;Life Quality;Attitude towards Psychotherapy;Dysfunctional Beliefs and Attitudes about Sleep ;

Countries

China

Contacts

Public ContactHuang Lei

Shanghai Tongji Hospital

huanglei@tongji.edu.cn+86 150 0188 8891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026