Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Sleep Disturbance; Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Internet-based CBT-I; Behavioral: Internet-based psychoeducation

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nora Choque Olsson, PhD; Phone Number: +46703788827; Email: nora.choque-olsson@psychology.su.se
• Study Contact Backup: Name: Markus Jansson-Fröjmark, Professor; Email: markus.jansson-frojmark@ki.se

Study Locations

• Sweden
  • Sverige
    • Stockholm, Sverige, Sweden
      • Nora Choque Olsson
      • Contact: Markus Jansson-Fröjmark, PhD
      • Contact: Nora Choque Olsson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based CBT-I; N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)	Behavioral: Internet-based CBT-I; 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.
Active Comparator: Internet-based psychoeducation; N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.	Behavioral: Internet-based psychoeducation; Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stockholm University
• Investigators: Principal Investigator: Nora Choque Olsson, PhD, Stockholm University

Publications and helpful links

General Publications

• Owens J. Classification and epidemiology of childhood sleep disorders. Prim Care. 2008 Sep;35(3):533-46, vii. doi: 10.1016/j.pop.2008.06.003.
• Bastien CH, Morin CM, Ouellet MC, Blais FC, Bouchard S. Cognitive-behavioral therapy for insomnia: comparison of individual therapy, group therapy, and telephone consultations. J Consult Clin Psychol. 2004 Aug;72(4):653-9. doi: 10.1037/0022-006X.72.4.653.
• Georen L, Jansson-Frojmark M, Nordenstam L, Andersson G, Olsson NC. Internet-delivered Cognitive Behavioral Therapy for insomnia in youth with autism spectrum disorder: A pilot study. Internet Interv. 2022 May 23;29:100548. doi: 10.1016/j.invent.2022.100548. eCollection 2022 Sep.

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 23, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Cognitive-behavioral treatment; Autism spectrum disorder; Internet delivered treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurodevelopmental Disorders; Dyssomnias; Parasomnias; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: Sleep Good Autism

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No