Insomnia Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old 2. Fulfils diagnostic criteria for insomnia disorder by the Diagnostic and Statistical Manual of Mental Disorder DSM-5
Exclusion criteria
Exclusion criteria: 1. In treatment with CBT-i or other psychological therapies for the treatment of insomnia 2. Insomnia secondary to sleep apnea; work shift; severe mental disorder (psychosis, bipolar disorders, depression higher); history of attempted autolysis; alcohol or drug abuse in the past year; Other sleep disturbances such as restless legs syndrome or parasomnias 3. Neurodegenerative diseases, oncological diseases with poor prognosis, acute or chronic pain secondary to diseases rheumatic and chronic decompensated diseases that produce insomnia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported sleep latency measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/08/2024: 1. Self-reported sleep duration measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 2. Self-reported sleep efficacy measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 3. Self-reported sleep severity (PSQI total score) measured using the Pittsburgh Sleep Quality Index at baseline and follow-up 4. The use of hypnotic and antidepressant medications (self-reported and measured by The Spanish-language version of the Severity of Dependency Scale) will be used to measure the use of benzodiazepines at 12 months 5. EuroQol Quality of life 5d at baseline at 12 months 6. Direct healthcare expenditures: These will be calculated based on costs related to medications, healthcare visits (PCPs, PCNs, hospital and community emergency services, and hospital specialists), diagnostic and therapeutic procedures, and inpatient care 7. Indirect costs: These will be calculated based on costs associated with work absences _____ Previous secondary outcome measures: 1. Self-reported sleep duration measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 2. Self-reported sleep efficacy measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 3. Self-reported sleep severity measured using the Pittsburgh sleep quality index at baseline and follow-up (12 months) 4. Number of defined daily doses of benzodiazepines in the last 6 months by the e-prescription system (12 months) 5. EuroQol Quality of life 5d at baseline at 12 months | — |
Countries
Spain