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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)

• Registration Number: NCT03492905
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-02
• Study Start: 2018-03-12
• Study First Submitted QC: 2018-04-08
• Study First Posted: 2018-04-10
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-based CBT	Internet-based Cognitive Behaviour Therapy (iCBT)	Internet-based Cognitive Behaviour Therapy (iCBT)

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI; Morin, 1993)	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 Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)	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.
Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983)	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.

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Uppsala Län, Sweden