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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56692
Enrollment
160
Registered
2024-04-11
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia, slaapstoornissen Insomnia sleeplessness

Interventions

Intervention: i-Sleep Autism is an adapted version of i-Sleep, a guided&nbsp
e-health intervention based on CBTi principles, aimed at improving sleep&nbsp
problems (insomnia) in autistic adults. It consists of 5 modules, which are to&nbsp
be completed in about 5 weeks, and a sleep diary. The intervention will be&nbsp
entirely held online, and participants will receive weekly feedback from a&nbsp
coach.

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: The primary outcome will be insomnia severity.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026