Insomnia Disorder Insomnia
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meeting DSM-5 diagnosis criteria of chronic insomnia. 2. Has insomnia symptoms of at least mild severity or worse on the Insomnia Severity Index (ISI >= 8) 3. 18 years of age or older
Exclusion criteria
Exclusion criteria: 1. engaged in shift work with night shifts 2. has other sleep disorders that are considered to have a significant impact on insomnia 3. expected to have disturbance in sleep rhythm due to hospitalization during the study 4. has received or is currently receiving structured psychotherapy 5. determined inappropriate by the doctor for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Self-rated Insomnia Severity (Insomnia Severity Scale: ISI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Validity: 1) Sleep diary 2) Sheehan Disability Scale (SDISS) *2) was not used due to copyright issues. Feasibility: 1) Survey of research consent rates 2) Occurrence of adverse events 3) Adverse effect checklist for CBT-I 4) Survey for implementation 5) Preference of CBT-I provision format | — |
Contacts
National Center of Neurology and Psychiatry