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

Depression Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adolescent
• Depression
• Depressive Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT06358898
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Contact: Rachel Ngan Yin Chan, PhD
• Phone: 39710548
• Email: rachel.chan@cuhk.edu.hk
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2024
• Completion date: December 31, 2026