iCBT for Adolescents With Co-morbid Insomnia

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

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.

Study Overview

• Status: Completed
• Conditions: Dyssomnias
• Intervention / Treatment: Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala Län
    • Uppsala, Uppsala Län, Sweden, 751 85
      • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Collaborators: Karolinska Institutet; Uppsala University
• Investigators: Principal Investigator: Vendela Zetterqvist, Ph D, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 15, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: CBT; Internet based
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias
• Other Study ID Numbers: 2015/326