Clinical trial NCT06358898: Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents
Official title: Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Depression
Adolescent
Keywords: Insomnia
Depression
Adolescent
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 343
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Chinese adolescent aged 12-18 years old
2. presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents)
3. presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression
4. ability to read and understand Chinese
5. possession of smartphone

Exclusion Criteria:

1. presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI)
2. a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
3. 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
4. currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression

Primary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary outcomes:
measure: Assessor-rated depressive symptomatology
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Overall severity of depression symptoms
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Severity of insomnia symptoms
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Sleep-wake pattern
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Sleep-related beliefs and cognitions
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Daytime sleepiness
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Anxiety and depression symptoms
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Quality of life by KIDSCREEN-27
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Other outcomes:
measure: Major life events and self-perceived stress
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Chronotype
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
measure: Pubertal status
timeFrame: Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Locations:
city: Sha Tin
country: Hong Kong
facility: Department of Psychiatry, the Chinese University of Hong Kong
state: New Territories
Study officials:
affiliation: Department of Psychiatry, the Chinese University of Hong Kong
name: Rachel Ngan Yin Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: