Objective: To test if participants with autism engaging in a CBT-I based online guided intervention (i-Sleep Autism) will experience a significant reduction in insomnia symptoms and improved mental health outcomes compared to the control group (…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
insomnia, slaapstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary outcome will be insomnia severity.
Secondary outcome
Secondary outcomes will be mental health, quality of life, depression, anxiety,
and daily functioning. Outcomes will be measured at baseline, mid-intervention
(3 weeks), at post-intervention (6 weeks after baseline), and at 6 months
follow up. We will also explore moderators (expectations, preference,
motivation, baseline symptom severity, insomnia duration) of the intervention
effect.
Background summary
Rationale: Sleeping problems, particularly insomnia, are among the most common
problems that autistic adults face, and these problems have an enormous impact
on the quality of life of this population. CBT-I is the first treatment choice
for insomnia, but autistic individuals might require an adjusted approach,
considering for example differences in sensory- and information processing,
social interactions, and (un)employment rates when compared to neurotypical
individuals. Internet-based CBT-I might be a promising venue to target insomnia
in this population, but to our knowledge, no guided internet-based CBTi
interventions have previously been developed and tested in adults with autism,
despite the pressing need.
Study objective
Objective: To test if participants with autism engaging in a CBT-I based online
guided intervention (i-Sleep Autism) will experience a significant reduction in
insomnia symptoms and improved mental health outcomes compared to the control
group (online psychoeducation and sleep hygiene).
Study design
Study design: We will employ a pragmatic, parallel, superiority randomized
controlled trial design comparing a guided e-health intervention to a minimally
active waitlist control condition with psychoeducation and sleep hygiene.
Intervention
Intervention: i-Sleep Autism is an adapted version of i-Sleep, a guided
e-health intervention based on CBTi principles, aimed at improving sleep
problems (insomnia) in autistic adults. It consists of 5 modules, which are to
be completed in about 5 weeks, and a sleep diary. The intervention will be
entirely held online, and participants will receive weekly feedback from a
coach.
Study burden and risks
The provision of a free, low-intensity CBTi self-help intervention poses
minimal risks. During sleep restriction, participants may experience increased
fatigue, and we provide adequate warnings for this. Thus far, no adverse events
have been reported in previous trials similar to CBTi. Adverse events are
regularly assessed at each follow-up, with coaches monitoring progress. In the
event of any (serious) adverse events, the researcher, under the supervision of
a licensed psychologist, will promptly reach out to the participant. The burden
for participants is limited, as participation in the research requires no
travel time, and interventions can be accessed at their convenience. The
completion of questionnaires takes approximately 15 minutes per assessment.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, the following inclusion
criteria apply:
(1) A participant must have a formal clinical diagnosis of Autism Spectrum
Disorder (ASD) as established by an authorized professional (e.g.,
psychiatrist/psychologist). This information is provided by the participant.
(2) A participant must be at least 18 years of age.
(3) A participant must have self-reported insomnia, with a cut-off score of 10
or higher on the Insomnia Severity Index.
(4) A participant must possess a desktop, laptop, tablet or mobile phone with
internet connectivity. The Minddistrict platform (on which the intervention
will be provided) does not have minimal hardware specifications. Minddistrict
and the Minddistrict app work best on modern devices that are not older than 5
years, with a preference for devices that are not older than 3 years.
(5) A participant must be able to read and write in the Dutch language.
Exclusion criteria
The following exclusion criteria apply to potential participants:
(1) Not being able to comply to the intervention due to night shifts, meaning
work between 2AM and 6AM at least once a week.
(2) Current or planned pregnancy or breast feeding, since sleep problems often
occur in pregnancy and parents of a newborn.
Other comorbid psychological disorders and somatic diseases are allowed, since
rates of psychiatric comorbidity are very high (81%) in this population (Vohra
et al., 2018). The use of (sleep) medication is also allowed and tracked by
asking: *Have you used sleep medication in the past 4 weeks?* (Yes/no). If yes,
we will ask which medications and how frequently these medications were taken.
Cannabis will also be included in the list of medications.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86228.018.24 |