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NCT Number: NCT03624400

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nora Choque Olsson

Stockholm, Sverige, Sweden

Location contact

Markus Jansson-Fröjmark, PhD

CONTACT

Nora Choque Olsson, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Sleep diaries by using Actigraphy

    Time frame: 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.

  2. Quality of sleep by using Athens Insomnia Scale (AIS)

    Time frame: 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.

  3. Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)

    Time frame: 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.

  4. Anxiety problems by using Spence Children's Anxiety Scale

    Time frame: 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.

  5. Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Jansson-Fröjmark, Professor

CONTACT

[email protected]

Nora Choque Olsson, PhD

CONTACT

[email protected]

+46703788827

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 10, 2018
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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