iCBT for Adolescents With Co-morbid Insomnia

Dyssomnias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612987
• Other study ID #: 2015/326
• Status: Completed
• Phase: N/A
• First received: November 15, 2015
• Last updated: March 2, 2018
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala	Uppsala Län

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	Karolinska Institutet, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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