Effectiveness and cost-effectiveness of internet-based treatment for insomnia in depressed patients treated at a mental healthcare outpatient clinic.
Recruiting
- Conditions
- depressieve stemmingstoornisdepressioninsomniamood disordersleeping problems10040991
- Registration Number
- NL-OMON50166
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- 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 abovementioned 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 <p>The main study parameter is the change in depressive symptoms within patients<br /><br>at 3, 6, 9 and 12 months of follow-up, as well as the difference between<br /><br>intervention and control groups. This will be assessed with the Patient Health<br /><br>Questionnaire-9 (PHQ-9). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are insomnia severity (Insomnia Severity Index, ISI), daily<br /><br>functioning (Work and Social Adjustment Scale, WSAS), general quality of life<br /><br>(EuroQol 5-level version, EQ-5D-5L), lost productivity costs (adapted version<br /><br>of the iMTA Productivity Cost Questionnaire, iPCQ) and healthcare, patient and<br /><br>family costs (adapted version of the iMTA Medical Cost Questionnaire, iMCQ).</p><br>