Insomnia disorder, Depression
Conditions
Interventions
Short-term behavioral therapy for insomnia (BBT-I) combined with circadian rhythm support (CRS) group:A 4-week therapist-guided and digitally delivered BBT-I + CRS delivered via mobile phone applicati
morning bright light therapy, caffeine intake restriction, exercise therapy, and restricted diet, as well as standardized health guidance on melatonin.
Sleep health education (HE) group:A 4-week therapist-guided and digitally delivered Health Education (HE) control group. Based on a standardized implementation manual, this group receives general know
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Han Chinese adolescents aged 12-18 years residing in Mainland China; 2) Meeting the diagnostic criteria for insomnia disorder according to the International Classification of Sleep Disorders – Third Edition (ICSD-3), as assessed by the revised Diagnostic Interview for Sleep Patterns and Disorders (DISP), defined as sleep difficulties and related daytime symptoms occurring at least three times per week for at least three months, accompanied by significant distress or daytime functional impairment, and not fully explained by other concurrent sleep-wake disorders, mental disorders, physical illnesses, or medication/substance use; 3) PHQ-9 score >=10; 4) ISI score >= 15; 5) Item 5 of ISI (To what extent do you consider your sleep problems to interfere with your daytime functioning) score >= 2; 6) Able to listen, speak, and read Mandarin Chinese; 7) Ability to use a smartphone normally; 8) Written informed consent signed by both the adolescent and their legal guardian.
Exclusion criteria
Exclusion criteria: 1) Currently moderate to severe or significant suicide risk or self-reported suicidal attempts based on clinical interview; 2) Comorbid physical illnesses (such as cancer) and organic brain diseases, including significant visual or hearing impairment, major neurological disorders, etc.; 3) Current or past diagnosis of severe mental disorders meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5), including but not limited to major depressive disorder, bipolar disorder, psychotic disorders, etc., as assessed by the revised Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL), or self-reported current mental disorder diagnosis by the participant; 4) Current diagnosis of other sleep disorders causing sleep disturbance meeting ICSD-3 criteria, as assessed by the revised DISP, including delayed sleep-wake phase disorder, sleep apnea, and restless legs syndrome; 5) Medical conditions confirmed by interview or self-reported medical history that may cause poor sleep quality and sleep continuity disruption, such as eczema, asthma, severe pain disorders requiring daily analgesic management, etc.; 6) Currently receiving psychotropic medications, such as Selective Serotonin Reuptake Inhibitors (SSRIs), other antidepressants, anxiolytics, hypnotics and sedatives, or antiepileptic drugs, steroid medications (dexamethasone, etc.), and other pharmacological treatments that may affect (or interfere with) sleep; 7) Currently receiving or having previously received systematic psychological or physical treatments targeting insomnia (such as Cognitive Behavioural Therapy for Insomnia, Tai Chi, transcranial magnetic stimulation, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First onset of Depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Persistence or remission of insomnia disorder;9-item Patient Health Questionnaire score;Hamilton Depression Scale score;7-item Generalized Anxiety Disorder Scale score;Insomnia Severity Index;Subjective sleep parameters (sleep diary);Objective sleep parameters (actigraphy);Reduced Morningness-Eveningness Questionnaire score;Munich Chronotype Questionnaire score;Pediatric Daytime Sleepiness Scale score;10-item Perceived Stress Scale score;Multidimensional Fatigue Inventory score;Ford Insomnia Response to Stress Test;6-item UCLA Loneliness Scale score;6-item De Jong Gierveld Loneliness Scale score;EuroQol 5-Dimension Questionnaire for Youth-3 level score;Child Health Utility-9D score;Pediatric Quality of Life Inventory Version 4.0 score;Health economics information ; | — |
Countries
China
Contacts
Public ContactJihui Zhang
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed