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iCBT for Adolescents With Co-morbid Insomnia

Primary Purpose

Dyssomnias

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based Cognitive Behaviour Therapy (iCBT)
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyssomnias focused on measuring CBT, Internet based

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iCBT

Arm Description

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI; Morin, 1993)
Given that this is an intervention study we are assessing changes in outcome over time.

Secondary Outcome Measures

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.
Symptoms Checklist (SCL-90; Derogatis et al., 1994)
Given that this is an intervention study we are assessing changes in outcome over time.
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.

Full Information

First Posted
November 15, 2015
Last Updated
March 2, 2018
Sponsor
Uppsala University Hospital
Collaborators
Karolinska Institutet, Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02612987
Brief Title
iCBT for Adolescents With Co-morbid Insomnia
Official Title
Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
Collaborators
Karolinska Institutet, Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyssomnias
Keywords
CBT, Internet based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCBT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-based Cognitive Behaviour Therapy (iCBT)
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI; Morin, 1993)
Description
Given that this is an intervention study we are assessing changes in outcome over time.
Time Frame
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 Measure Information:
Title
The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)
Description
Given that this is an intervention study we are assessing changes in outcome over time.
Time Frame
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
Title
Symptoms Checklist (SCL-90; Derogatis et al., 1994)
Description
Given that this is an intervention study we are assessing changes in outcome over time.
Time Frame
Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Title
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
Description
Given that this is an intervention study we are assessing changes in outcome over time.
Time Frame
Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vendela Zetterqvist, Ph D
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Uppsala Län
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

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iCBT for Adolescents With Co-morbid Insomnia

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