iCBT for Adolescents With Co-morbid Insomnia

NCT02612987 | Completed

• 1 other identifier: 2015/326
• Study Type: interventional
• Target: 21
• 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. 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.

Conditions

Dyssomnias

Keywords

CBT; Internet based

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI; Morin, 1993)

  Given that this is an intervention study we are assessing changes in outcome over time.

  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 Outcomes (3)

• The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)

  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

• Symptoms Checklist (SCL-90; Derogatis et al., 1994)

  Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

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

  Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

Study Arms (1)

iCBT

EXPERIMENTAL

Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT)

Interventions

Internet-based Cognitive Behaviour Therapy (iCBT) BEHAVIORAL

iCBT

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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
• No psychotropic medication or being on a stable dosage for at least six weeks before enrollment

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
• Karolinska Institutet: collaborator
• Uppsala University: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 751 85, Sweden

Location

MeSH Terms

Conditions

Dyssomnias

Condition Hierarchy (Ancestors)

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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D, licensed psychologist

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 24, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

SE (1)