depressieve stemmingstoornis depression insomnia mood disorder sleeping problems
Conditions
Interventions
i-Sleep is a guided, internet-based cognitive behavioural therapy for insomnia,
which will be added to usual care for depression in specialized mental
healthcare. The i-Sleep program consists of 5 o
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 18 years or older with a maximum age of 75 years, • Scheduled for treatment of unipolar depression according to the DSM-5 criteria at one of the abovementioned specialized mental healthcare outpatient clinics, • Fulfilling the DSM-5 criteria for insomnia disorder.
Exclusion criteria
Exclusion criteria: • Insufficient command of the Dutch language, • Working night shifts, • Sleep-related conditions other than insomnia, e.g. sleep apnoea, • No daily access to an internet-connected computer, • Presence of a mental health crisis situation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the change in depressive symptoms within patients at 3, 6, 9 and 12 months of follow-up, as well as the difference between intervention and control groups. This will be assessed with the Patient Health Questionnaire-9 (PHQ-9). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), lost productivity costs (adapted version of the iMTA Productivity Cost Questionnaire, iPCQ) and healthcare, patient and family costs (adapted version of the iMTA Medical Cost Questionnaire, iMCQ). | — |
Countries
Netherlands
Outcome results
None listed