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

Study 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. 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.

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

Conditions
-----------------
Insomnia

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


Participation Criteria
=================
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 Exclusion Criteria: Ongoing manic or psychotic episode Being at high risk of triggering manic or psychotic episode Ongoing sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT<br>Internet-based Cognitive Behaviour Therapy (iCBT) | Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)<br>* Guided self-help for 7 weeks. Contact with therapist 2 times per week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI; Morin, 1993) | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994) | 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. | Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed) | 
| Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983) | 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. | Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed) |