Effectiveness of a guided e-health CBT-I based intervention for insomnia in autistic adults (i-Sleep Autism)

Conditions: insomnia, slaapstoornissen
Insomnia
sleeplessness

Registration Number: NL-OMON56692

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 160

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The primary outcome will be insomnia severity. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be mental health, quality of life, depression, anxiety,<br /><br>and daily functioning. Outcomes will be measured at baseline, mid-intervention<br /><br>(3 weeks), at post-intervention (6 weeks after baseline), and at 6 months<br /><br>follow up. We will also explore moderators (expectations, preference,<br /><br>motivation, baseline symptom severity, insomnia duration) of the intervention<br /><br>effect. </p><br>