Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

NCT03624400 | Not Yet Recruiting

• 1 other identifier: Sleep Good Autism
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Sleep Disturbance; Insomnia

Keywords

Autism spectrum disorder; Sleep; Cognitive-behavioral treatment; Internet delivered treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Sleep diaries by using Actigraphy

  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)

  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)

  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

  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)

  Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up

Study Arms (2)

Internet-based CBT-I

EXPERIMENTAL

N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)

Behavioral: Internet-based CBT-I

Internet-based psychoeducation

ACTIVE COMPARATOR

N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.

Behavioral: Internet-based psychoeducation

Interventions

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 CBT-I

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.

Internet-based psychoeducation

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stockholm University: lead

Study Sites (1)

Nora Choque Olsson

Stockholm, Sverige, Sweden

Location

Related Publications (3)

• 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.

  PMID: 18710669 BACKGROUND

• 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.

  PMID: 15301650 BACKGROUND

• 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.

  PMID: 35651733 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Nora Choque Olsson, PhD

  Stockholm University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Choque Olsson, PhD

CONTACT

+46703788827; nora.choque-olsson@psychology.su.se

Markus Jansson-Fröjmark, Professor

CONTACT

markus.jansson-frojmark@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal investigator

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: August 10, 2018
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

SE (1)