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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03492905

Enrollment

Registered

2018-04-10

Start date

2018-03-12

Completion date

2020-10-31

Last updated

2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

BEHAVIORALInternet-based Cognitive Behaviour Therapy (iCBT)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Masking description

Outcome assessment is automatic, pre-programmed, on-line

Eligibility

Sex/Gender

ALL

Age

13 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Insomnia Severity Index (ISI; Morin, 1993)	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)	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

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026