insomnia
Conditions
Interventions
The I-Sleep intervention is a 5 week online CBT i-sleep program to be completed
by the participant at home and consisting of psycho-education, sleep hygiene,
sleep restriction, stimulus control, cog
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Able to speak, write and understand Dutch; • Voluntary participation; • >= 18 years of age; • Access to a computer and the internet; • Provided written informed consent; • Willing to comply with the study procedures ; • Meeting criteria of diagnosis insomnia (DSM-5) as assessed by the online baseline screening - Difficulty initiating or maintaining sleep for at least 3 nights per week, - for at least 3 months, - causing clinically significant distress or impairment in daily functioning. Daytime consequences will be assessed using 5 items introduced by Espie et al. (2012)
Exclusion criteria
Exclusion criteria: • Working night shifts; • Meeting criteria of the diagnosis of sleep apnoea; • Using medication affecting sleep (i.e. anti-psychotics, anxiolytic); • Having received psychological treatment for insomnia in the last six months; • Pregnancy or breast feeding during the trial; • Current depression, schizophrenia, psychosis or suicidal ideation; • Alcohol consumption > 21 units/week; • Not willing to give up blood donation during the study; • Any significant medical reason for exclusion as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/endpoints: at baseline, 3 months and 6 months, we will determine glycaemic control, measured by levels of HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline, 3 months and 6 months cardiovascular risk factors, including fasting glucose and diabetes medication use as well as sleep, measured by validated questionnaires, sleep dairies, accelerometers and sleep medication prescription. In addition, BMI, waist circumference, lipid levels, cholesterol levels, dietary intake, physical activity, mood and quality of life measured. These parameters are determined using anthropometrical measurements, blood pressure measurements, lipid levels by measuring triglycerides and cholesterol, while dietary intake will be measured using a food frequency questionnaire, physical activity by wearing an accelerometers, while mood and quality of life are measured by validated questionnaires. | — |
Countries
Netherlands
Outcome results
None listed