Effectiveness and cost-effectiveness of internet-based treatment of insomnia in depressed patients treated at a mental healthcare outpatient clinic.
Recruiting
- Conditions
- nipolar depression, insomnia disorder
- Registration Number
- NL-OMON22668
- Lead Sponsor
- Amsterdam UMC (locatie VUmc)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 175
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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).