insomnia depressive symptoms primary insomnia sleep problems
Conditions
Interventions
Of the 130 people suffering from ID that participate in the RCT participants,
at least 30 will be randomly assigned to one of the following three conditions:
CBT-I, CT or CBT-I combined with CT. It
Sponsors
VU Medisch Centrum, Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participants have to be at least 18 years old and less than 70 years old. - Additional inclusion criteria for the insomnia group specifically: * a diagnosis of insomnia according to the International Classification of Sleep Disorders (ICSD-2) * an Insomnia Severity Index score (ISI) *10 - Additional inclusion criteria for the RCT specifically: * a high score on the ISQ (cut-off to be determined).
Exclusion criteria
Exclusion criteria: - a current clinical diagnosis of major depressive disorder or a diagnosis of major depressive (DSM-4) assessed with the Composite International Diagnostic Interview * Short Form (CIDI-SF) - Diagnosed sleep apnea syndrome (OSAS) (AHI >15), restless leg syndrome (RLS) or periodic limb movement (PLMD) (PLMI > 25). Using the screening survey, we will exclude candidates with moderate to very severe RLS according to an IRLS scale score > 15 and candidates with a high risk of OSAS according to the Berlin questionnaire. In candidates suspect for PLMD according to the Duke Structured Interview for Sleep Disorders, the PLMI will be determined from the polysomnographic recordings of the pre-assessment; cases with a PLMI of 25 or more will be advised to consult a sleep specialist. - a known eye condition incompatible with light exposure - a history of light-induced migraine or epilepsy, or severe side effects to bright light in the past. - MRI contraindications such as non-MR compatible metal implants, claustrophobia, pregnancy * Current treatment with antidepressant medication * Night work or rotating shift-work
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the RCT is the severity of depressive symptoms during one year following the treatment. Depressive symptoms are measured with the Inventory of Depressive Symptomatology Self Report (IDS-SR). The primary effect of interest is the integrated treatment effect on IDS-SR at T1 to T4 relative to T0. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary endpoint is a diagnosis of Depression based on a Composite International Diagnostic Interview * Short Form (CIDI-SF), which will be performed at baseline (to exclude patients with a DSM-5 depression diagnosis) and at 12 months. Other secondary outcome measures of the RCT are the severity of insomnia and the cost-effectiveness of each treatment calculated form health care and work absenteeism. Severity of insomnia will be measured with the Insomnia Severity Index (ISI), Consensus Sleep Diary (CSD) and actigraphy recordings. Cost-effectiveness will be asses with the Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P). | — |
Countries
Netherlands
Outcome results
None listed