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Completed

NCT Number: NCT03492905

Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia

Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Results from a pilot study shows that outpatients of Children and Youth Psychiatry can improve their sleep and depressive symptoms by receiving internet-based cognitive behavioral therapy for insomnia (iCBT). This study is designed to evaluate implementation of the treatment in routine care.The study will evaluate aspects of the implementation process such as organizational attitudes towards iCBT before implementation, level of knowledge about the condition and intervention among health-care providers before and after the implementation, and clinical outcomes in routine care.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic 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

Uppsala University Hospital

Uppsala, Uppsala County, 751 85, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To fulfill the diagnostic criteria for insomnia
  • To have access to a computer with Internet connection
  • No previous or ongoing CBT for insomnia

Exclusion criteria

  • Ongoing manic or psychotic episode
  • Being at high risk of triggering manic or psychotic episode
  • Ongoing sleep apnea

Treatment and study plan

Internet-based Cognitive Behaviour Therapy (iCBT)

Behavioral

Guided self-help for 7 weeks. Contact with therapist 2 times per week.

Primary outcomes

  1. Insomnia Severity Index (ISI; Morin, 1993)

    Time frame: Pre-treatment, weekly for seven weeks (during treatment), after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

    Change in severity of insomnia is assessed by measuring ISI at several measurement points before, during and after treatment. The score ranges from 0-28, higher values indicate worse symptoms of insomnia.

Secondary outcomes

  1. Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)

    Time frame: Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

    Change in depressive symptoms is assessed by measuring MADRS-S at several measurement points before, during and after treatment. The score ranges from 0-35, higher values indicate worse symptoms of depression.

  2. Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983)

    Time frame: Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

    Change in clinician-rated level of functioning is assessed by measuring C-GAS at several measurement points before, during and after treatment. The score ranges from 0-100, higher values indicate better functioning.

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Karolinska University
  • Uppsala University

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2018
Registry last updated
Apr 27, 2021

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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