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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358898
• Other study ID #: 20221207
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: Rachel Ngan Yin Chan, PhD
• Phone: 39710548
• Email: rachel.chan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 343
• Est. completion date: December 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 (usually last for 6-8weeks).
• 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.

Locations

Country	Name	City	State
Hong Kong	Department of Psychiatry, the Chinese University of Hong Kong	Sha Tin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major life events and self-perceived stress	Life Experience Survey (LES) will be used to measure major life events and self-perceived stress associated with these events that an individual experienced over the year.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Other	Chronotype	Morningness-Eveningness Questionnaire (MEQ) will be used to measure the chronotype of the study participants.; Individuals scored higher than 17 and lower than 12 were classified as morning-type and evening-type, respectively. Individuals scored between 12 and 17 were classified as intermediate-type. Scores range from 4 to 25.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Other	Pubertal status	Self-rated tanner stage will be used to measure pubertal status of the participants.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Primary	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	Assessor-rated depressive symptomatology	Hamilton Rating Scale for Depression (HRSD), a 17-item clinician-administered instrument, will be used to assess depressive symptomatology. Scores range from 0 to 52, with higher score indicate higher level of depression.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Overall severity of depression symptoms	Improvement of depression, in reference to the severity prior to the start of the treatment, will be rated using the Clinical Global Improvement Scale (CGI-I), on a scale of 1 (very much improved) to 7 (very much worse).	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Severity of insomnia symptoms	Severity of insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Sleep-wake pattern	Prospective 7-day Sleep diary will be used to record sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Sleep-related beliefs and cognitions	Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) will be used to measure faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia. The total score is calculated from the average score of all the items on the scale and could range from 0 to 10.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Daytime sleepiness	8-item Pediatric Daytime Sleepiness Scale (PDSS) will be used to assess adolescents' daytime sleepiness in school children and adolescents. It is an 8-item inventory designed for use with school children and youths, with a higher score indicating greater sleepiness. Scores ranged from 0 to 32.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Anxiety and depression symptoms	Cantonese-Chinese version Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression. It has been validated in the community-based sample of adolescents in Hong Kong.; A higher total score of each subscale represents a greater severity of depression/anxiety. The total score for each subscale ranges from 0 to 21.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up
Secondary	Quality of life by KIDSCREEN-27	KIDSCREEN-27 health questionnaire for children and young people will be used to measure quality of life.; A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.	Baseline, Postintervention (8 weeks), 6-month follow up and 12-month follow up