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Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Primary Purpose

Autism Spectrum Disorder, Sleep Disturbance, Insomnia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based CBT-I
Internet-based psychoeducation
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nora Choque Olsson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-based CBT-I

Internet-based psychoeducation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Quality of sleep by using Athens Insomnia Scale (AIS)
AIS is a self-administered questionnaire assessing the quality of sleep.
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.
Anxiety problems by using Spence Children's Anxiety Scale
The SCAS is a 38-item parent report measure of children's anxiety.
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.

Full Information

First Posted
June 23, 2018
Last Updated
September 9, 2022
Sponsor
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT03624400
Brief Title
Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
Official Title
Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Sleep Disturbance, Insomnia
Keywords
Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based CBT-I
Arm Type
Experimental
Arm Description
N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)
Arm Title
Internet-based psychoeducation
Arm Type
Active Comparator
Arm Description
N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT-I
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based psychoeducation
Intervention Description
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.
Primary Outcome Measure Information:
Title
Change in sleep impairment by using The Insomnia Severity Index (ISI)
Description
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
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Secondary Outcome Measure Information:
Title
Sleep diaries by using Actigraphy
Description
An actigraph is a small instrument worn on the wrist or ankle to measure body movement and nighttime sleep parameters.
Time Frame
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Title
Quality of sleep by using Athens Insomnia Scale (AIS)
Description
AIS is a self-administered questionnaire assessing the quality of sleep.
Time Frame
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Title
Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)
Description
The DD-CGAS is an instrument used by clinicians to rate patients' global everyday functioning.
Time Frame
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Title
Anxiety problems by using Spence Children's Anxiety Scale
Description
The SCAS is a 38-item parent report measure of children's anxiety.
Time Frame
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Title
Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)
Description
The DERS-16 is a brief version of self-report measure of emotion regulation difficulties.
Time Frame
Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Choque Olsson, PhD
Organizational Affiliation
Stockholm University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nora Choque Olsson
City
Stockholm
State/Province
Sverige
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18710669
Citation
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.
Results Reference
background
PubMed Identifier
15301650
Citation
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.
Results Reference
background
PubMed Identifier
35651733
Citation
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.
Results Reference
background

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Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

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