Effect of treatments for insomnia on depressive symptoms in persons with insomnia prone to depressio

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Age ≥ 18 years and < 70 years

2. Diagnosis of insomnia according to the International Classification of Sleep Disorders (ICSD-3) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).

Exclusion Criteria

1. A current clinical diagnosis of major depressive disorder or a diagnosis of major depressive assessed with the Composite International Diagnostic Interview – Short Form (CIDI-SF).

2. People in whom symptoms of obstructive sleep apnea syndrome (OSAS), restless legs syndrome (RLS) and periodic limb movement disorder (PLMD), are a major cause of disturbed sleep will be excluded. First, we will ask people if they have been clinically diagnosed with one of these sleep disorders. If they have been diagnosed indeed, they will be excluded in case of a polysomnographically assessed apnea hypopnea index (AHI) of 15 or more or periodic limb movement index (PLMI) of 25 or more. Second, using the screener survey, we will exclude candidates with moderate to very severe RLS according to an IRLS scale score > 15 17 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 ≥ 25 will be advised to consult a sleep specialist.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the severity of depressive symptoms during one year following the intervention. 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 (7 weeks, directly after the six-week intervention) to T4 (52 weeks) relative to T0 (baseline).

Secondary Outcome Measures

Name	Time	Method
A secondary endpoint is a diagnosis of depression based on a Composite International Diagnostic Interview – Short Form (CIDI-SF), which will be performed at T0 (baseline) and at T4 (52 weeks). Other secondary outcome measures 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 assessed with the Trimbos and iMTA questionnaire on Costs associated with Psychiatric Illness (TIC-P).<br /><br>Another secondary outcome measure is the effect of the intervention (CBT-I and/or CT) on brain structure and function (assessed with MRI) at T1 relative to T0.