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

NCT03492905 | Completed

• 1 other identifier: 2017/373
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

• Childrens Global Assessment Scale (C-GAS; Shaffer et al., 1983)

  Pre-treatment, after 7 weeks (i.e. post-treatment), after 7 weeks and 4 months (i.e. 4 months after treatment is completed)

Study Arms (1)

Internet-based CBT

EXPERIMENTAL

Internet-based Cognitive Behaviour Therapy (iCBT)

Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)

Interventions

Internet-based Cognitive Behaviour Therapy (iCBT) BEHAVIORAL

Guided self-help for 7 weeks. Contact with therapist 2 times per week.

Internet-based CBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To fulfill the diagnostic criteria for insomnia
• To have access to a computer with Internet connection
• No previous or ongoing CBT for insomnia

You may not qualify if:

• Ongoing manic or psychotic episode
• Being at high risk of triggering manic or psychotic episode
• Ongoing sleep apnea

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Uppsala University: collaborator
• Karolinska University: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 751 85, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Vendela Zetterqvist, Ph D

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessment is automatic, pre-programmed, on-line
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: licensed clinical psychologist, PhD

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 10, 2018
• Study Start: March 12, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)