Insomnia Nervous System Diseases
Conditions
Interventions
Current interventions as of 13/12/2023:
Due to natural capacity limitations, some intervention group participants may have to wait to begin treatment. Waiting times over 2-3 months rarely occur. The l
Sponsors
Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria based on self-report and national registries: 1. Adults older than 18 years of age 2. Self-referred to the study 3. Insomnia Severity Index score of 12 or higher
Exclusion criteria
Exclusion criteria: Exclusion criteria based on self-report: 1. Bipolar disorder 2. Schizophrenia or other psychotic disorders 3. Personality disorders 4. Dementia and other neurodegenerative disorders 5. Heart surgery within the last 3 months 6. Untreated sleep apnea 7. Undergoing cancer treatment at the screening timepoint 8. Multiple sclerosis with an attack at screening timepoint 9. Adults without adequate skills in the Norwegian language to participate in the group-delivered course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia measured using the Insomnia Severity Index at baseline, 4 weeks, 3 months (primary measurement point), and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At baseline, 4 weeks, 3 months (primary measurement point), and 6 months, all participants fill out the following secondary outcome measures: 1.1. Fatigue measured using the Chalder Fatigue Scale 1.2. Subjective sleep patterns measured using a 7-day digital sleep diary 1.3. Health-related quality of life measured using EuroQol EQ5D-5L 1.4. Mental distress measured using the Hopkins Check List 1.5. Chronotype measured using Brief Horne-Østberg Morningness-Eveningness questionnaire 1.6. Patient beliefs and attitudes about sleep measured using Dysfunctional Beliefs and Attitudes about Sleep questionnaire 1.7. Sleep reactivity measured using Ford Insomnia Response to Stress Test 2. At baseline, intervention group participants fill out the following secondary outcome measures: 2.1. Motivation for treatment measured using Nijmegen Motivation List 2 2.2. Treatment expectancy measured using Credibility/Expectancy Questionnaire 3. At 3 months, intervention group participants fill out the following secondary outcome measures: 3.1. Utility of CBT-I measured using Treatment Components Adherence Scale 4. Participant demographic information measured using a questionnaire at baseline 5. At 12 months and 24 months the following outcomes will be measured: 5.1. Short - and medium-term impact of group-delivered CBT-I on rates of sick leave, and medication and health resource utilization measured by accessing national health registry data 5.2. Overview of health service utilization measured by obtaining data from the Norwegian Patient Registry 5.3. Overview of prescribed medication measured by obtaining data from the Norwegian Prescription Database 5.4. Information on sick leave measured by obtaining data from the National Insurance Administration | — |
Countries
Norway
Outcome results
None listed