Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
Sponsor study identifier
interventional
343
1 country
1
Study Start
April 20, 2024
Actual (reported)Primary Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2024
Actual (reported)April 11, 2024
Actual (reported)April 20, 2024
Actual (reported)May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Depressive symptoms
The severity of depressive symptoms as measured by Patient Health Questionnaire 9-item (PHQ-9): locally validated in adolescents and commonly used self-administered questionnaire to assess depressive symptoms and severity. Scores range from 0 to 27, with higher score indicate higher level of depression.
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Assessor-rated depressive symptomatology
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Overall severity of depression symptoms
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Severity of insomnia symptoms
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-wake pattern
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Sleep-related beliefs and cognitions
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Major life events and self-perceived stress
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Chronotype
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Pubertal status
Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
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.
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.
This standard digital CBT-I intervention will cover (1) psycho-education about sleep, circadian and sleep hygiene education, (2) stimulus control, (3) sleep restriction, (4) relaxation techniques, (5) structured worry time, (6) cognitive restructuring (targeting sleep-related dysfunctional cognitions), and (7) relapse prevention. In order to have comparable dosage as modified CBT-I, the treatment will be dispersed to 8 modules (8-week) which is still in the range of standard CBT-I duration (usually last for 6-8weeks).
Department of Psychiatry, the Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Rachel Ngan Yin Chan, PhD
Department of Psychiatry, the Chinese University of Hong Kong
First Submitted
April 2, 2024
First Posted
April 11, 2024
Study Start
April 20, 2024
Actual (reported)Primary Completion
May 31, 2026
Estimated (date passed)Perinatal Research on Improving Sleep and Mental Health
Additional depression specific components will be added to the standard CBT-I, including behavioral activation and problem solving.
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Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 10, 2025
Record last verified: 2025-07
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