RecruitingNot ApplicableNCT06358898

Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents

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


Sponsor

Chinese University of Hong Kong

Enrollment

343 participants

Start Date

Apr 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a digital version of CBT-I (Cognitive Behavioral Therapy for Insomnia) — a structured program that changes sleep habits and thought patterns — delivered through an app, specifically designed for Chinese teenagers who have both insomnia and depression. **You may be eligible if...** - You are a Chinese teenager aged 12–18 - You have insomnia (scoring 9 or higher on the Insomnia Severity Index) - You have depressive symptoms (scoring 10 or higher on the PHQ-9 questionnaire) - You can read and understand Chinese - You own a smartphone **You may NOT be eligible if...** - You have significant suicidal thoughts, plans, or past attempts - You have been diagnosed with psychosis, schizophrenia, bipolar disorder, or intellectual disability - You have another sleep disorder (like sleep apnea or restless legs) that significantly disrupts sleep Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStandard dCBT-I

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).

BEHAVIORALModified Mood enhanced CBT-I (M-dCBT-I)

Additional depression specific components will be added to the standard CBT-I, including behavioral activation and problem solving.


Locations(1)

Department of Psychiatry, the Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

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NCT06358898


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