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Clinical Trials/NCT02612987
NCT02612987
Completed
Not Applicable

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

Uppsala University Hospital1 site in 1 country21 target enrollmentOctober 2015
ConditionsDyssomnias

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dyssomnias
Sponsor
Uppsala University Hospital
Enrollment
21
Locations
1
Primary Endpoint
Insomnia Severity Index (ISI; Morin, 1993)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vendela Zetterqvist

Ph D, licensed psychologist

Uppsala University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)(Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up)
  • The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)(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)
  • Symptoms Checklist (SCL-90; Derogatis et al., 1994)(Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up)

Study Sites (1)

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