CBTI Insomnia
Conditions
Brief summary
Insomnia is one of major public health problems.This study aimed to assess benefits and problems of CBT-I for chronic insomnia based on the influence of Chinese tradition and culture.
Detailed description
Participants with chronic insomnia were enrolled to a 6 weeks CBT-I program . At baseline and follow-up to week 12, all patients were assessed using polysomnography (PSG), sleep diary and subjective scales.
Interventions
BEHAVIORALcognitive behavioral therapy for insomnia
CBT-I has been developed as a structured clinical practice, which integrates a constellation of treatment components, such as stimulus control, sleep restriction，relaxation therapy, cognitive therapy and sleep hygiene education
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* were diagnosed as chronic insomnia based on the third edition of the International Classification of Sleep Disorders(ICSD-3) ; * agree to participate in this study and sign informed consent.
Exclusion criteria
* Patient Health Questionnaire(PHQ-9)\> 15 points; * hallucinations or taking antipsychotic medication at the time of evaluation; * Insomnia due to drug side effects, other illnesses or co-morbidities; * dementia according to 4th edition of the Diagnostic and Statistical Manual of Mental Disorders; * severe physical illness or severe abnormalities in heart, liver, kidney and thyroid function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Polysomnography (PSG) parameters - TST | 6 weeks. | total sleep time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Polysomnography (PSG) parameters-SOL | 6 weeks | sleep onset latency (SOL) |
| Change of Polysomnography (PSG) parameters-TIB | 6 weeks | time in bed (TlB) |
| Change of Polysomnography (PSG) parameters-SE | 6 weeks | sleep efficiency(SE) |
| Change of Polysomnography (PSG) parameters-REM latency | 6 weeks | Rapid Eye Movement (REM) |
| Change of Polysomnography (PSG) parameters- Stage R | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-Stage N1 | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-Stage N2 | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-Stage N3 | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-Arousal | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-SpO2 mean | 6 weeks | — |
| Change of Polysomnography (PSG) parameters-AHI | 6 weeks | apnea-hypopnea index (AHI) |
| Change of sleep diary parameters-SOL | 6 weeks | sleep onset latency (SOL) |
| Change of sleep diary parameters-TST | 6 weeks | total sleep time (TST) |
| Change of sleep diary parameters-TIB | 6 weeks | time in bed (TlB) |
| Change of sleep diary parameters-SE | 6 weeks | sleep efficiency(SE) |
| Change of sleep diary parameters-NAD | 6 weeks | number of awakenings during the night (NAD) |
| Change of sleep diary parameters-WASO | 6 weeks | wake time after sleep onset (WASO) |
| Change of lSl | 12 weeks | insomnia severity index. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia symptoms. A decrease from baseline indicates improvement. |
| Change of PSQl | 12 weeks | Pittsburg sleep quality index. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A decrease from baseline indicates improvement. |
| Change of SAS | 12 weeks | Self-Rating Anxiety Scale. The index score ranges from 20 to 80, with higher scores indicating more severe anxiety symptoms. A decrease from baseline indicates improvement. |
| Change of SDS | 12 weeks | Self-rating depression scale. The index score ranges from 20 to 80, with higher scores indicating more severe depressive symptoms. A decrease from baseline indicates improvement. |
Countries
China
Contacts
STUDY_CHAIRhuailian guo, Dr,
Peking University People's Hospital
Outcome results
None listed