Table 2.
The Schedule of Enrolment, Interventions, and Assessments
| Study Period | ||||||
|---|---|---|---|---|---|---|
| Enrolment | Allocation | Post-Allocation | ||||
| TIMEPOINT | - | 0 | End of Rehabilitation | 3 Months | 6 Months | 12 Months |
| ENROLMENT: | ||||||
| Eligibility screen | X | |||||
| Informed consent | X | |||||
| Allocation | X | |||||
| INTERVENTIONS: | ||||||
| Usual care |  |
|||||
| Usual care+dCBT-I |  |
|||||
| ASSESSMENTS: | ||||||
|
Baseline Age Sex Education Work status Anxiety and depression Physical activity |
X | |||||
|
Primary outcome Insomnia severity index (ISI) |
X | X | X | X | X | |
| Secondary outcomes | ||||||
| Pain intensity | X | X | X | X | X | |
| Fatigue | X | X | X | X | X | |
| Sleep diary (Usual care + dCBT-I only) | X | X | ||||
| Health-related quality of life (EQ-5D) | X | X | X | X | X | |
| Work ability | X | X | X | X | X | |
| Expectations length of sick leave | ||||||
| Physical function | X | X | X | X | X | |
| Registry data Sickness absence and disability pension Sleep and pain medication | X | |||||
Abbreviation: dCBT-I, digital cognitive behavioral therapy for insomnia.