Insomnia
Conditions
Interventions
Healthy Controls:None
Insomnia Disorder:Digital Brief Behavioral Therapy for Insomnia (BBTI) / Sleep Hygiene Education
Sponsors
Peking University Sixth Hospital ( Institute of Mental Health )
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Insomnia Disorder Han Chinese ethnicity and right-handed; age between 18 and 60 years, male or female; junior high school education or above, with a Mini-Mental State Examination (MMSE) score >= 27; despite adequate opportunity and circumstances for sleep, the participant experiences persistent (>1 month) difficulty initiating sleep, maintaining sleep, or early morning awakening, occurring at least three times per week; Insomnia Severity Index (ISI) total score > 10, with an interference or distress item score > 2; patients with depressive disorder or anxiety disorder diagnosed according to DSM-5 may be included if they have been on stable medication (SSRI or SNRI within therapeutic range) for more than one month. Definition of "Stable Medication": (1) Continuous medication use without interruption (missing more than 2 consecutive days or >=4 total missed doses per month is considered "unstable"); dosage remains within the therapeutic range. (2) No persistent or frequent intense suicidal or self-harm ideation or behavior; no frequent episodes of core symptoms such as excessive worry, tension, or fear; and no panic attacks (e.g., sudden chest tightness or feelings of impending death). 2. Healthy Controls Han Chinese ethnicity and right-handed; meets criteria for normal sleep; aged 18–60 years, male or female; junior high school education or above, with a Mini-Mental State Examination (MMSE) score >= 27; no subjective complaints of sleep disturbance; during both the past six months and a two-week sleep diary period, self-reported sleep onset latency < 15 minutes and wake after sleep onset < 15 minutes on at least five nights per week; Insomnia Severity Index (ISI) total score <= 7, with interference and distress item scores < 2; regular sleep schedule during the past three months, with habitual bedtime between 9:00 p.m. and 1:00 a.m.
Exclusion criteria
Exclusion criteria: 1. Insomnia Disorder (1) Current or past diagnosis of any psychiatric disorder other than depressive or anxiety disorders according to DSM-5; patients using tricyclic antidepressants (TCAs) or monoamine oxidase inhibitors (MAOIs) are excluded; (2) Presence of severe cardiovascular, hepatic, pulmonary, renal, or other systemic diseases, as well as organic brain disorders or progressive diseases (e.g., cancer, neurodegenerative disorders such as Alzheimer’s disease or Parkinson’s disease, autoimmune diseases, etc.); (3) Use of hypnotic medications (e.g., benzodiazepines) or alcohol consumption after 7:00 p.m. within two weeks prior to enrollment; (4) Current use of medications known to induce insomnia (e.g., corticosteroids, methylphenidate, modafinil, theophylline, ephedrine, clonidine, etc.); (5) Presence of other sleep disorders, including moderate or severe sleep apnea syndrome (apnea–hypopnea index > 15), restless legs syndrome, periodic limb movement during sleep (arousal-related periodic limb movement index > 20 per hour), or circadian rhythm sleep–wake disorders (e.g., advanced sleep phase syndrome); (6) Contraindications to magnetic resonance imaging (MRI), including any metallic implants or foreign bodies, or claustrophobia; (7) Pregnant or lactating women, or those planning to become pregnant within the next three months; (8) Shift workers or individuals who have traveled across time zones within the past three months; (9) Body mass index (BMI) >= 35 kg/m^2; (10) Previous experience with structured psychotherapy, or having received physical therapies such as repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), or light therapy within one month prior to enrollment. (If the participant is only included in the cross-sectional study, this item should be disregarded.) 2. Healthy Controls (1) History of any neurological or psychiatric disorders; (2) Presence of severe cardiovascular, hepatic, pulmonary, renal, or other systemic diseases, as well as organic brain disorders or progressive diseases (e.g., cancer, neurodegenerative disorders such as Alzheimer’s disease or Parkinson’s disease, autoimmune diseases, etc.); (3) High risk of suicide; (4) Presence of sleep disorders, including insomnia disorder, moderate or severe sleep apnea syndrome (apnea–hypopnea index > 15), or periodic limb movement during sleep (arousal-related periodic limb movement index > 20 per hour); (5) Contraindications to magnetic resonance imaging (MRI), including any metallic implants or foreign bodies, or claustrophobia; (6) Pregnant or lactating women, or those planning to become pregnant within the next three months; (7) Shift workers or individuals who have traveled across time zones within the past three months; (8) Body mass index (BMI) >= 35 kg/m^2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Insomnia Severity Index Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Multidimensional assessment of sensory perception;Awakening Before Falling Asleep Scale;Sleep Self-Efficacy Scale;Positive Negative Emotion Scale;Adverse Childhood Experience Questionnaire;Electroencephalography-functional Magnetic Resonance Imaging;Adult Resilience Scale;Sleep Beliefs and Attitudes Questionnaire;9-Item Patient Health Questionnaire;Morning and night self-rating scale - 19 items;Mini-Mental State Examination, commonly known as the Folstein Test;Big Five Personality Questionnaire - Neuroticism;Epworth Sleepiness Scale;Social Readaptation Rating Scale;Multidimensional Dream Questionnaire;Chinese version of the Highly Sensitive Scale;Ford Stress Insomnia Response Test Scale;Depression self-rating scale;Hyperarousal Scale;STOP-BANG Scale;Polysomnography;Fatigue Severity Scale;Glasgow Sleep Effort Scale;Intimacy Experience Scale;Awakening Tendency Scale;7-Item Generalized Anxiety Disorder Scale;Anxiety Self-Rating Scale;Revised Event Impact Scale;State Trait Anxiety Questionnaire;Sleep diary; | — |
Countries
China
Contacts
Public ContactSun Hongqiang
Peking University Sixth Hospital ( Institute of Mental Health )
Outcome results
None listed