We hypothesize that improving sleep will improve glycaemic control in people with T2DM and insomnia. To test this hypothesis, we established the following objectives: 1) investigate if improving sleep by internet-based cognitive behavioural therapy…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/endpoints: at baseline, 3 months and 6 months, we will
determine glycaemic control, measured by levels of HbA1c.
Secondary outcome
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.
Background summary
A novel lifestyle factor associated with type 2 diabetes mellitus (T2DM) are
sleep disturbances. Our recent meta-analysis shows that sleep problems,
especially insomnia are 3 times more prevalent in people with T2DM, compared to
the general population, with 20-40% of all people with T2DM suffering from
sleep problems. In addition, our recent meta-analysis showed that insomnia is
associated with faster diabetes progression. The question that remains is can
we improve glycaemic control in people with T2DM by treating their insomnia?
Previously, a small pilot study on cognitive behavioural therapy in 9 women
with T2DM with insomnia showed that although not significantly by treatment of
insomnia, HbA1c levels reduced on average 0.26 ± 0.28% from pre-test to the
three-week follow-up.
Study objective
We hypothesize that improving sleep will improve glycaemic control in people
with T2DM and insomnia. To test this hypothesis, we established the following
objectives: 1) investigate if improving sleep by internet-based cognitive
behavioural therapy (CBT) can improve insomnia and glycaemic control in people
with T2DM; 2) assess whether CBT also improves BMI, waist circumference,
lipids, blood pressure, dietary intake, physical activity, mood and quality of
life.
Study design
We will perform a randomized controlled trial to assess the effect of CBT
(i-sleep) versus care as usual on insomnia and glycaemic control in people with
T2DM and insomnia. Randomization will take place at the individual level on a
1:1 ratio, using random sequence block randomisation (blocks of 2 or 4 or 6).
Participants will receive the outcome of randomization by email. Due to the
nature and design of the study, blinding of the researchers and participants is
not possible.
Intervention
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, cognitive restructuring and relapse
prevention. A research nurse will offer guidance and feedback to increase
motivation and adherence. The control condition is care-as usual. The control
group will gain access to the intervention six months after inclusion.
Study burden and risks
The main burden of participating in this trial will be adhering to the online
CBT program, i.e. completing homework assignments and questionnaires, and
wearing an accelerometer. Patients may experience side effects of the treatment
during the first 1-2 weeks due to instructed sleep restriction, e.g. fatigue,
daytime sleepiness, and/or loss of motivation/energy. In addition, participants
will be asked to visit the research centre three times, during which
anthropometric measures, blood pressure, questionnaires, blood collection and
wearing an accelerometer for a week. In relation to the possibility of damage,
the severity of potential harm and the vulnerability of the participants, it is
concluded that the conduct of the research involves a negligible risk to human
participants and is therefore justified.
De Boelelaan 1089a
Amsterdam 1081 HV
NL
De Boelelaan 1089a
Amsterdam 1081 HV
NL
Listed location countries
Age
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
• 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
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 | NL68074.029.18 |
| OMON | NL-OMON23530 |