ight therapy as add-on therapy to Cognitive Behaviour Therapy for Insomnia (CBT-I) - a pilot study
- Conditions
- Insomnia Disorder (DSM-5)
- Registration Number
- DRKS00029640
- Lead Sponsor
- IVERSITÄTSKLINIKUM FREIBURG, Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
1. Diagnosis Insomnia Disorder (according to DSM-5)
2. Age = 18 years
3. Written informed consent
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index (Insomnia Severity Index) at T1 (post-treatment)
- Secondary Outcome Measures
Name Time Method 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)