Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Change in insomnia symptom severity
Study Overview
Brief Summary
The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.
Detailed Description
PARTICIPANT RECRUITMENT:
For recruitment, this pilot trial will be advertised at child and adolescent mental health services and primary care clinics, as well as through newspapers. The inclusion procedure will be carried out in two steps: 1) telephone interview and 2) face-to-face assessment.
Telephone interview: An initial telephone interview will be conducted with the adolescent/parent in order to broadly assess inclusion and exclusion criteria.
Face-to-face baseline diagnostic assessment: After the telephone screening, the adolescent along with his/her parents, are invited to a face-to-face assessment at the Child and Adolescent Mental Health clinic, including the diagnostic screening interview MINI-KID conducted with adolescents and parents jointly. Insomnia diagnoses will be established using DSM-IV criteria and levels of insomnia symptoms will be determined using ISI-a. If the ISI-a score is >10, the family will be invited to participate in the study, provided that the other inclusion criteria are fulfilled and no exclusion criteria prohibit participation. Following face-to-face assessment, participants will be provided with an information sheet and consent form.
DATA COLLECTION:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical levels of insomnia symptoms, as determined by ISI-a >
- •Age between 13 and 17 years
- •Ability to read and write Swedish
- •Daily access to the internet through a computer or similar device
- •Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Exclusion Criteria
- •Diagnosed with autism spectrum disorder, psychosis or bipolar disorder
- •Present risk of suicide
- •Ongoing substance dependence
- •Completed CBT for sleep disorders within the last 6 months (defined as at least 5 sessions of CBT
- •Ongoing use of central nervous system stimulant medication
Outcomes
Primary Outcomes
Change in insomnia symptom severity
Time Frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Insomnia Severity Index- adolescent version ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity. The instrument has been adapted to teenagers, ISI-a, and validated on Swedish teenagers.
Secondary Outcomes
- Change in subjective sleep onset latency(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in subjective wake after sleep onset(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in subjective sleep efficiency(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in objective sleep total sleep time(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in objective sleep onset latency(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in objective wake after sleep onset(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in symptoms of insomnia(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in subjective total sleep time(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in objective sleep efficiency(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in symptoms of depression(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in symptoms of generalized anxiety(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in intensity of pain(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in daytime sleepiness 1(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in symptoms of depression 2(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in difficulties in emotion regulation(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in daytime functioning(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
- Change in daytime sleepiness 2(Change from before treatment to after (+6 weeks) and to 6 month after treatment)
Investigators
Mats Lekander
Professor
Karolinska Institutet