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

NCT06358898 | Recruiting

• 1 other identifier: 20221207
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia; Depression; Adolescent

Keywords

Insomnia; Depression; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

Standard dCBT-I

ACTIVE COMPARATOR

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.

Behavioral: Standard dCBT-I

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

EXPERIMENTAL

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.

Behavioral: Modified Mood enhanced CBT-I (M-dCBT-I)

Interventions

Standard dCBT-I BEHAVIORAL

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).

Standard dCBT-I

Modified Mood enhanced CBT-I (M-dCBT-I) BEHAVIORAL

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

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, the Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rachel Ngan Yin Chan, PhD

  Department of Psychiatry, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ngan Yin Chan, PhD

CONTACT

39710548; rachel.chan@cuhk.edu.hk

Jucheng Yu, PhD

CONTACT

39710548; juchengyu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

HK (1)