Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder; Insomnia; Sleep Disturbance

• Registration Number: NCT03624400
• Lead Sponsor: Stockholm University

Brief Summary

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.

Detailed Description

Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.

Study Timeline

• Study First Submitted: 2018-06-23
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Study Start: 2025-01-15
• Primary Completion: 2028-06-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in sleep impairment by using The Insomnia Severity Index (ISI)	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Sleep diaries by using Actigraphy	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	An actigraph is a small instrument worn on the wrist or ankle to measure body movement and nighttime sleep parameters.
Quality of sleep by using Athens Insomnia Scale (AIS)	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	AIS is a self-administered questionnaire assessing the quality of sleep.
Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	The DERS-16 is a brief version of self-report measure of emotion regulation difficulties.
Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	The DD-CGAS is an instrument used by clinicians to rate patients' global everyday functioning.
Anxiety problems by using Spence Children's Anxiety Scale	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up	The SCAS is a 38-item parent report measure of children's anxiety.

Trial Locations

Locations (1)

Nora Choque Olsson; 🇸🇪 Stockholm, Sverige, Sweden