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OpenTrials
Completed

NCT Number: NCT02612987

iCBT 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. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly assessments will also be made during treatment on primary outcome and a presumed process variable constructed for the purpose of this trial.

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Key information

Conditions

Dyssomnias Mental Disorders Nervous System Diseases Sleep Wake Disorders

Age range

13 year–18 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
  • No psychotropic medication or being on a stable dosage for at least six weeks before enrollment

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

Primary outcomes

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

    Time frame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

    Given that this is an intervention study we are assessing changes in outcome over time.

Secondary outcomes

  1. The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)

    Time frame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

    Given that this is an intervention study we are assessing changes in outcome over time.

  2. Symptoms Checklist (SCL-90; Derogatis et al., 1994)

    Time frame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

    Given that this is an intervention study we are assessing changes in outcome over time.

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

    Time frame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

    Given that this is an intervention study we are assessing changes in outcome over time.

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Karolinska Institutet
  • Uppsala University

Registry information

Official study title

Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2015
Registry last updated
Mar 5, 2018

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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