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ID
Source
Brief title
Health condition
Unipolar depression, insomnia disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Patients with unipolar depression often simultaneously meet the DSM-5 criteria for insomnia disorder. These patients have significantly lower quality of life and worse treatment outcomes than depressive patients without insomnia. While cognitive behavioral therapy for insomnia (CBT-I) is the treatment option of first choice, insomnia is currently, if recognized accurately, often treated pharmacologically. A pilot study has already shown that the online CBT-I intervention i-Sleep could potentially serve as a relatively easily accessible addition to the usual care for depression. However, a randomized controlled trial evaluating the effectiveness and cost-effectiveness of adding i-Sleep to usual care among depressed patients has not yet been performed. The current project aims to assess both the effectiveness and cost-effectiveness of an internet-based insomnia intervention (i-Sleep) prior to usual care for depression, compared to usual care alone, in depressive patients with comorbid insomnia treated at a specialized mental healthcare outpatient clinic. Furthermore, a process evaluation of implementing i-Sleep in daily clinical practice will take place.
Study objective
We hypothesize that addition of i-Sleep to usual care for depression improves patient outcomes and reduces societal costs as compared to usual care alone.
Study design
Repeated assessments will take place at baseline (prior to the start of treatment) and at 3, 6, 9, and 12 months of follow-up.
Intervention
A guided, internet-based cognitive behavioral therapy program for insomnia (i-Sleep). This online CBT-I program consists of five sessions, containing information and exercises on sleep.
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 participating specialized mental healthcare outpatient clinics,
- Fulfilling the DSM-5 criteria for insomnia disorder.
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8955 |
| CCMO | NL73477.029.20 |
| OMON | NL-OMON50166 |