DSM-5: insomnia disorder F51.0
Conditions
Interventions
Group 1: Intervention group (internet-delivered CBT-I): Patients receive an internet-delivered CBT-I intervention (online program on a WordPress-based online platform comprising six lessons including
Sponsors
Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. insomnia disorder according to DSM-5 2. age = 18 years 3. internet access and possession of a computer 4. residence within 1 hour travel distance of a study centre 5. command of the German language 6. informed written consent
Exclusion criteria
Exclusion criteria: 1. any history of additional sleep disorder 2. severe or unstable medical or psychiatric diseases that that require immediate treatment, that have an impact on outcome variables or that may be negatively influenced by sleep restriction 3. imminent suicide risk 4. pregnancy 5. current psychotherapeutic treatment, or presence on a waiting list for such treatment 6. Participation in another clinical trial up to 30 days prior to the start of and during participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) after intervention (10 weeks after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcomes ? Insomnia Severity Index (ISI) at 6 months ? Fatigue Severity Scale (FSS) at 10 weeks, at 6 months ? Daylight exposure questionnaire (self-constructed) at 10 weeks, at 6 months ? International Physical Activity Questionnaire (IPAQ) at 10 weeks, at 6 months ? Patient Health Questionnaire 9 (PHQ9) at 10 weeks, at 6 months ? Assessment of Quality of Life (AQoL-6D) at 10 weeks, at 6 months ? slider bar item of the EQ-5D-5L at 10 weeks, at 6 months safety ? Questionnaire of Adverse Events on CBT-I ? Adverse Events (eCRF) ? Negative Effects Questionnaire (NEQ) health economic evaluation ? Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) descriptive and exploratory endpoints ? E-Therapy Attitude Measure (ETAM) ? (e)Therapy Attitudes and Process Questionnaire (eTAP/TAP) ? Preference for type of therapy (face-to-face vs. online), ? Patient Acceptance and Convenience Questionnaire ? Adherence Questionnaire ? User Experience Questionnaire (UEQS) | — |
Countries
Germany
Contacts
Public ContactFee Benz
Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed