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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492905
• Other study ID #: 2017/373
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2021
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 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

Exclusion Criteria:

• Ongoing manic or psychotic episode

• Being at high risk of triggering manic or psychotic episode

• Ongoing sleep apnea

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Internet-based Cognitive Behaviour Therapy (iCBT)
Guided self-help for 7 weeks. Contact with therapist 2 times per week.

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala	Uppsala Län

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	Karolinska University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)
Secondary	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.	Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)