iCBT for Adolescents With Co-morbid Insomnia

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyssomnias

Intervention / Treatment
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* Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT<br> | Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI; Morin, 1993) | Given that this is an intervention study we are assessing changes in outcome over time. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012) | Given that this is an intervention study we are assessing changes in outcome over time. | 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) | Given that this is an intervention study we are assessing changes in outcome over time. | Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up | 
| Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994) | Given that this is an intervention study we are assessing changes in outcome over time. | Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Internet based