Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358898
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-02
Brief Title:
Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None