iCBT for Adolescents With Co-morbid Insomnia

Not Applicable

Completed

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

• Registration Number: NCT02612987
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-15
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-24
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

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