The current project aims (1) to unravel underlying mechanisms for the insomnia subtype that has a high risk to convert to depression by evaluating their profile of psychological traits, health history, life events, behavioral habits, environmental…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
insomnia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Major depression is among the most burdening and costly chronic health hazards.
Its prognosis is poor and treatment effectiveness is at best moderate. With a
prevalence of 4-10% in the general population chronic insomnia is the most
frequent complaint in general practice. Insomnia, which represents a
heterogeneous mix of different subtypes, contributes to cognitive and health
care problems, including risk of developing of developing depression.
Meta-analysis shows that ±13% of people with insomnia develop depression within
a year. The proposed project will address how the insomnia subtype that is
prone to depression can be identified early by means of differences in
psychological traits, behavioral habits, environmental exposures and in brain
structure and function. Moreover, the project will address which of the
currently available interventions, including internet-based cognitive
behavioral therapy for insomnia (CBT-I), chronotherapy (CT), or a combination
of these, works best to treat their insomnia and to prevent depression.
Study objective
The current project aims (1) to unravel underlying mechanisms for the insomnia
subtype that has a high risk to convert to depression by evaluating their
profile of psychological traits, health history, life events, behavioral
habits, environmental exposure, brain structure and brain function, and (2) to
compare effectiveness of interventions for insomnia and their possible
secondary gain of preventing depression.
Study design
Randomized single-blind repeated measures intervention study combined with
cross-sectional case-control comparison. The study involves a 9-day
observational ambulatory measurement period, 1 night of HD-EEG measurements,
MRI scan and filling in questionnaires. The insomnia group that is at high risk
of developing a depression will be included in an RCT and will undergo a second
MRI scan.
Intervention
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 is estimated that at most ten will not
be assigned because they don't want to receive an intervention.
Study burden and risks
Both CBT-I and CT have very low risks. Participants will not be exposed to
risks any different than in their everyday life. Light exposure, body
temperature manipulations and physical activity intensity will not exceed
individual capacity. The burden associated with participation is mostly the
demands on the participants* time and effort.
Oldenaller 1
Amsterdam 1070 BB
NL
Oldenaller 1
Amsterdam 1070 BB
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63139.029.17 |
| OMON | NL-OMON22122 |