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

Primary Purpose

Insomnia

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 health services research trial for Insomnia

Eligibility Criteria

13 Years - 17 Years (Child)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

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

Internet-based CBT

Arm Description

Internet-based Cognitive Behaviour Therapy (iCBT)

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI; Morin, 1993)
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

Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
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)
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.

Full Information

First Posted
March 2, 2018
Last Updated
April 26, 2021
Sponsor
Uppsala University Hospital
Collaborators
Uppsala University, Karolinska University
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1. Study Identification

Unique Protocol Identification Number
NCT03492905
Brief Title
Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia
Official Title
Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Outcome assessment is automatic, pre-programmed, on-line
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based CBT
Arm Type
Experimental
Arm Description
Internet-based Cognitive Behaviour Therapy (iCBT)
Intervention Type
Behavioral
Intervention Name(s)
Internet-based Cognitive Behaviour Therapy (iCBT)
Intervention Description
Guided self-help for 7 weeks. Contact with therapist 2 times per week.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI; Morin, 1993)
Description
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.
Time Frame
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)
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
Description
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.
Time Frame
Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)
Title
Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983)
Description
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.
Time Frame
Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 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 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

Plan to Share IPD
No

Learn more about this trial

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

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