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Recruiting NCT06358898

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

No phase Interventional Insomnia Depression Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard dCBT-I, Modified Mood enhanced CBT-I (M-dCBT-I).
Who it may be relevant to
Registry conditions: Insomnia, Depression, Adolescent. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

Adolescence is a critical transitional stage accompanied by the emergence of mental disorders, with major depressive disorder (MDD) being the most common mental disorder. The point prevalence of depression ranges from 3% to 18% across different studies. In addition, according to our previous studies, approximately 10% of adolescents experience insomnia disorders, and 36% have insomnia symptoms. Adolescent concurrently experiencing sleep and mood problems are typically at a higher risk of adverse health outcomes. This particular group is usually much more difficult to treat, with a poorer prognosis, suggesting that this group maybe in particular need for effective treatment.

There is accumulating evidence that adolescent sleep and mood problems can be treated successfully using cognitive behavioral therapy (CBT), which is one of the most extensively evaluated non-pharmacological approach for managing either depression or insomnia symptoms in adolescents. Cognitive behavioral therapy for depression (CBT-D) involves psychoeducation and addresses cognitive restructuring for unrealistic thinking contribute to depressed mood and behavioral strategies to increase pleasant activities. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment in managing adult insomnia, it has gained increasing empirical evidence in managing adolescent insomnia. The high comorbidity of insomnia and depression calls for the need for addressing both problems due to the fact that residual insomnia or residual depressive symptoms could further hasten a relapse to the other comorbid disorder. In addition, depression becomes more difficult to treat in the presence of insomnia. In fact, there has, however, been emerging encouraging evidence showing 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. Primary outcomes include the depressive symptoms as measured by PHQ-9, while secondary outcomes include clinician rated depression scale (HRSD), insomnia (ISI), sleep-related measures (Sleep diary variables, dysfunctional sleep belief), daytime sleepiness, anxiety (HADS), quality of life (Kidscreen-27). Outcome measurement will be conducted at baseline, postintervention, 6-month and 12-month follow up.

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 (usua
  • 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.

Primary outcome measures

  • Depressive symptoms [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
Secondary outcome measures (8)
  • Assessor-rated depressive symptomatology [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Overall severity of depression symptoms [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Severity of insomnia symptoms [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Sleep-wake pattern [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Sleep-related beliefs and cognitions [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Daytime sleepiness [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Anxiety and depression symptoms [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]
  • Quality of life by KIDSCREEN-27 [Time frame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Department of Psychiatry, the Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT06358898 · 20221207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗