Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-30
Brief Title:
Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients
Sponsor:
Christin Lang
Organization:
University of Basel
Study Overview
Official Title:
Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling SLEEPAC in Adolescent Psychiatric Patients A Blended Care Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
SLEEPAC
Brief Summary:
Mental health disorders pose a significant burden on adolescent populations globally often accompanied by sleep disturbances Emerging evidence suggests that addressing sleep issues can improve mental health outcomes while physical activity is increasingly recognized as beneficial for both sleep and mental well-being This study aims to assess the effectiveness of a novel intervention SLEEPAC combining cognitive-behavioral therapy for insomnia CBT-I circadian treatment and PA counseling compared to treatment as usual TAU in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances Secondary outcomes include improvements in sleep health physical activity levels cognitive performance and self-esteem Additionally the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography EEG contributing to advancements in precision psychiatry for this population
Detailed Description:
Background and rationale Mental health disorders are the leading cause of disability in adolescents worldwide 70 to 80 of individuals with mental disorders experience sleep disturbances Preliminary evidence from adult studies suggest that treating sleep disturbances in these patients can improve mental health outcomes Moreover regular physical activity PA is increasingly promoted as a remedy for sleep and other mental health problems Thus combining sleep therapy and PA counseling may synergistically improve mental health outcomes in adolescent psychiatric patients Guidance on how to address sleep disturbances and PA counselling among this population in routine clinical care has the potential to improve clinical and psychosocial outcomes
Overall objectives To improve psychopathology in adolescent psychiatric outpatients with comorbid sleep disturbances by testing a novel behavioral intervention TRANSPAC that improves both sleep and PA levels This multi-component intervention combines CBT-I circadian treatment and PA counseling and will be compared against treatment as usual TAU
Specific aims With the prospect of further developing and fine-tuning transdiagnostic treatment protocols for young psychiatric patients with comorbid sleep disturbances the objectives of the proposed study are twofold 1 To test the efficacy of a novel transdiagnostic blended care e-health sleep CBT-I circadian treatment and PA therapy and to test its efficacy against TAU The primary endpoint is severity reduction of psychopathology Improvements of sleep health and regular PA levels will be investigated as secondary outcomes 2 To evaluate the prognostic value of sleep neurophysiological biomarkers high-density sleep-EEG on intervention efficiency thereby advancing current approaches in precision psychiatry
Methods The proposed study will recruit 140 psychiatric outpatients with comorbid sleep problems from our partner clinics in Basel and Bern KJP-UPD Bern UKBB Basel Inclusion criteria aged 13-18 years presence of sleep problems in addition to a psychiatric diagnosis Adolescents will be serially randomized over 15 years into one of 2 intervention arms a TRANSPAC or b TAU The intervention will be delivered in 6 sessions over 12 weeks Data will be collected at 3 time points Baseline post-intervention and 6-months follow-up Psychopathological load will be assessed via Symptom Checklist-90-Revised The composite sleep health score is based on self-reported sleep quality -quantity and timing complemented by 7-day sleep tracker Oura Ring Gen3 PA will be assessed objectively via the same device Oura Ring was selected due to prior compliance issues among this population with Actigraph Primary biomarkers are the micro-architectural features of sleep assessed by a high-density sleep-EEG such as sleep spindles slow wave activity and REM-latency Secondary biomarkers include heart rate variability and fitness
Expected results The proposed study aims to further develop and fine-tune transdiagnostic treatment protocols ie for multiple psychiatric disorders in adolescent psychiatric outpatients with sleep disturbances Testing the potential of sleep treatments for improving psychopathology in young psychiatric patients is a promising and highly novel approach Thus it is expected that both TRANSPAC and TAU will improve psychopathology in youth with TRANSPAC resulting in superior effects than TAU alone
Impact The onset of mental health disorders is often during adolescence requiring countermeasures at an early developmental stage Since sleep disturbances are a diagnostic feature for many psychiatric disorders treating sleep problems transdiagnostically may positively impact other health outcomes PA counseling may complement the benefits of the sleep intervention working in concert to improve mental health outcomes
Overall objectives To improve psychopathology in adolescent psychiatric outpatients with comorbid sleep disturbances by testing a novel behavioral intervention TRANSPAC that improves both sleep and PA levels This multi-component intervention combines CBT-I circadian treatment and PA counseling and will be compared against treatment as usual TAU
Specific aims With the prospect of further developing and fine-tuning transdiagnostic treatment protocols for young psychiatric patients with comorbid sleep disturbances the objectives of the proposed study are twofold 1 To test the efficacy of a novel transdiagnostic blended care e-health sleep CBT-I circadian treatment and PA therapy and to test its efficacy against TAU The primary endpoint is severity reduction of psychopathology Improvements of sleep health and regular PA levels will be investigated as secondary outcomes 2 To evaluate the prognostic value of sleep neurophysiological biomarkers high-density sleep-EEG on intervention efficiency thereby advancing current approaches in precision psychiatry
Methods The proposed study will recruit 140 psychiatric outpatients with comorbid sleep problems from our partner clinics in Basel and Bern KJP-UPD Bern UKBB Basel Inclusion criteria aged 13-18 years presence of sleep problems in addition to a psychiatric diagnosis Adolescents will be serially randomized over 15 years into one of 2 intervention arms a TRANSPAC or b TAU The intervention will be delivered in 6 sessions over 12 weeks Data will be collected at 3 time points Baseline post-intervention and 6-months follow-up Psychopathological load will be assessed via Symptom Checklist-90-Revised The composite sleep health score is based on self-reported sleep quality -quantity and timing complemented by 7-day sleep tracker Oura Ring Gen3 PA will be assessed objectively via the same device Oura Ring was selected due to prior compliance issues among this population with Actigraph Primary biomarkers are the micro-architectural features of sleep assessed by a high-density sleep-EEG such as sleep spindles slow wave activity and REM-latency Secondary biomarkers include heart rate variability and fitness
Expected results The proposed study aims to further develop and fine-tune transdiagnostic treatment protocols ie for multiple psychiatric disorders in adolescent psychiatric outpatients with sleep disturbances Testing the potential of sleep treatments for improving psychopathology in young psychiatric patients is a promising and highly novel approach Thus it is expected that both TRANSPAC and TAU will improve psychopathology in youth with TRANSPAC resulting in superior effects than TAU alone
Impact The onset of mental health disorders is often during adolescence requiring countermeasures at an early developmental stage Since sleep disturbances are a diagnostic feature for many psychiatric disorders treating sleep problems transdiagnostically may positively impact other health outcomes PA counseling may complement the benefits of the sleep intervention working in concert to improve mental health outcomes
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