Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

ConditionsAutism Spectrum Disorder Sleep Disturbance Insomnia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-17

SponsorStockholm University

About this trial

This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).

Insomnia diagnosis or sleep problems according to DSM-5

Intelligence quotient (IQ) > 70 according to Wechsler Intelligence Scale for Children - fourth edition

Psychiatric comorbidities according to DSM-5: anxiety disorders or depression.

Disqualifiers

The presence of clinically assessed self-injury

High risk of suicidal behaviour

borderline personality disorder or any form of schizophrenia or related disorders;

substance abuse as well as physical illness or condition that was largely influence sleep condition.

Trial design

Design model

Parallel

Treatments tested in this trial

Internet-based CBT-I
Behavioral
The adapted Internet-based CBT-I for adolescents with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 8 weekly modules and each module consists of several website pages that will be presented in a fixed order, with preprogrammed modules containing information, interactive questionnaires, descriptions of exercises and movies.
Internet-based psychoeducation
Behavioral
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Internet-based CBT-IExperimental treatment 1 intervention

Group B: Internet-based psychoeducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in sleep impairment by using The Insomnia Severity Index (ISI)

The ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Participants rate the following components on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely): (a) severity of sleep-onset, sleep-maintenance, and early morning awakening problems; (b) satisfaction with current sleep pattern; (c) interference with daily functioning; (d) noticeability of impairment attributed to the sleep problem; and (e) level of distress caused by the sleep problem. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity.

Time frame