Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

NCT ID: NCT03624400

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2029-12-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Sleep Disturbance Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Internet-based CBT-I

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

Group Type EXPERIMENTAL

Internet-based CBT-I

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Internet-based psychoeducation

Intervention Type BEHAVIORAL

Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm University

OTHER

Sponsor Role lead

Responsible Party

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Nora Choque Olsson

PhD, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nora Choque Olsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Stockholm University

Locations

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Nora Choque Olsson

Stockholm, Sverige, Sweden

Site Status

Countries

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Sweden

Central Contacts

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Nora Choque Olsson, PhD

Role: CONTACT

+46703788827

Markus Jansson-Fröjmark, Professor

Role: CONTACT

Facility Contacts

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Nora Choque Olsson, PhD

Role: primary

Markus Jansson-Fröjmark, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 18710669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15301650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35651733 (View on PubMed)

Other Identifiers

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Sleep Good Autism

Identifier Type: -

Identifier Source: org_study_id