Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Stockholm University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder; Insomnia; Sleep Disturbance

Treatments: Behavioral: Internet-based CBT-I; Behavioral: Internet-based psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03624400

Sleep Good Autism

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Internet-based CBT-I

Experimental group

Description:

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

Treatment:

Behavioral: Internet-based CBT-I

Internet-based psychoeducation

Active Comparator group

Description:

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

Treatment:

Behavioral: Internet-based psychoeducation