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

NCT06358898 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Standard 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).

BEHAVIORAL

Modified 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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Rachel Ngan Yin Chan, PhD · Department of Psychiatry, the Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358898 on ClinicalTrials.gov