Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial

NCT04616157 | Completed

• 1 other identifier: 2017/2315-31/2
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder; Depressive Disorder; Anxiety Disorders; Pain, Chronic; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in insomnia symptom severity

  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.

  Change from before treatment to after (+6 weeks) and to 6 month after treatment

Secondary Outcomes (17)

• Change in subjective total sleep time

  Change from before treatment to after (+6 weeks) and to 6 month after treatment

• 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

Study Arms (1)

ICBT-I

EXPERIMENTAL

The ICBT-I treatment program is a web-based intervention consisting of six chapters/sessions that adolescents go through during six consecutive weeks.The program starts with psychoeducation regarding sleep disorders and the rationale for a cognitive behavioral intervention. The main focus for the treatment is behavioral interventions, mainly sleep restriction and stimulus control. The intervention also addresses problem solving, maintenance of treatment gains, relapse prevention and relaxation techniques. Caregivers will not actively participate in the treatment. During the treatment phase participants will be in contact with a therapist through standardized forms in the program.

Behavioral: ICBT-I

Interventions

ICBT-I BEHAVIORAL

Cognitive-behavioral therapy for insomnia

ICBT-I

Eligibility Criteria

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

You may qualify if:

• Clinical levels of insomnia symptoms, as determined by ISI-a \>10.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

BUP KFE

Stockholm, 11364, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder; Anxiety Disorders; Chronic Pain; Inflammation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mats Lekander, PhD

  Karolinska Institutet

  STUDY CHAIR

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: Professor

Model Details: All participants will receive treatment

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: November 4, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-10

Locations

SE (1)