Insomnia Disorder (DSM-5)
Conditions
Interventions
Group 1: CBT-I + Light Therapy
CBT-I duration: 4 session on a weekly level à 50 minutes
light therapy duration: at least 4x/week à 20minutes each session for the treatment period with CBT-I (normally around 4 weeks)
Group 2: CBT-I + Placebo
light therapy duration: at least 4x/week à 20minutes each session for the treatment period with CBT-I (normally around 4 weeks) with a placebo lamp (reduced illuminance and warmer color temperature)
Sponsors
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis "Insomnia Disorder" (according to DSM-5) 2. Age = 18 years 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. instable, progressive or degenerative medicial condition 2. acute pain or poorly managed chronic pain, if causally linked to insomnia 3. uncontrolled psychiatric condition requiring immediate treatment outside of study 4. abuse or dependency of alcohol, medication or any illegal substance within the past year 5. evidence of sleep disorders except insomnia disorder according to ICDS-3. 6. evidence of intellectual disability 7. intake of sleep medication 2 weeks prior to and during the study period 8. shift-working or time zone flight within the last 4 weeks prior to or during the study period 9. suicidality 10. history of treatment with CBT-I or light therapy 11. evidence of eye disease precluding treatment with light 12. history of light-induced migraine or epilepsy or history of serious adverse events due to bright light 13. participation in other projects during the last 4 weeks prior study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (Insomnia Severity Index) at T1 (post-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia severity (Insomnia Severity Index) at T2 (3-months follow-up); the following parameters are secondary outcomes at T1: wake time after sleep onset, total sleep time, sleep efficiency (sleep diary and actigraphy), cortisol awakening response and melatonin onset (both assessed from saliva), physical activity and daylight exposure (items for self-rating and actigraphy including a light sensor, respectively); the following parameters are secondary outcomes at T1 and T2: Daytime sleepiness (Epworth Sleepiness Scale), sleep quality (Pittsburgh Sleep Quality Index), depression score (Beck Depression Inventory-II) | — |
Countries
Germany
Contacts
Public ContactSarah Schmid
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed