Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Chinese adolescent aged 12-18 years old

• presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents)

• presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression

• ability to read and understand Chinese

• possession of smartphone

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Psychiatry, the Chinese University of Hong Kong
RECRUITING
Shatin
Contact Information
Primary
Rachel Ngan Yin Chan, PhD
rachel.chan@cuhk.edu.hk
39710548
Backup
Jucheng Yu, PhD
juchengyu@cuhk.edu.hk
39710548
Time Frame
Start Date: 2024-04-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 343
Treatments
Active_comparator: Standard dCBT-I
Treatment content for insomnia was structured and based on the well-established CBT elements for treating insomnia, with developmental adaptation and age-appropriate modification specific for adolescent population. For example, regularity of sleep wake pattern and circadian component will be further emphasized in this age group given the high prevalence of social jetlag resulting from the early school schedule and their natural development delay in circadian rhythm.
Experimental: Modified Mood enhanced CBT-I (M-dCBT-I)
For mood-enhanced dCBT-I (M-dCBT-I), apart from including core CBT-I component, additional depression specific component including behavioral activation and problem solving. More specifically, cognitive restructuring techniques will cover both unhelpful belief relevant to both insomnia and depression. Psychoeducation will also cover both condition and vignette example will be included in the treatment.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov