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

Inclusion Criteria5

  • 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

Exclusion Criteria4

  • presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI)
  • a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
  • presence of other sleep disorders that significantly affect sleep continuity or sleep quality (e.g. restless leg symptoms or obstructive sleep apnea syndrome) as determined by validated Diagnostic Interview for Sleep Patterns and Disorders
  • currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression

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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