Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920630
Status:
TERMINATED
Last Update Posted:
2023-08-23
First Post:
2021-05-27
Brief Title:
TRAIN Your Sleep Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia CBT-I
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
TRAIN Your Sleep Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia CBT-I
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research team members no longer employed Determination made to utilize pilot data already obtained and close study to enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study is to understand how insomnia contributes to chronic pain in youth Specifically the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the bodys ability to efficiently modulate pain either to increase or decrease pain perception It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation which will improve after treatment of insomnia In this project the objectives are to 1 evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms and 2 evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation
Study participation will consist of a baseline assessment a 5 session once per week virtual group cognitive behavioral therapy for insomnia CBT-I intervention and a follow-up assessment Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits Assessment visits will consist of two types of assessments questionnaires and quantitative sensory testing QST Participating parents and teens will complete questionnaires both child and parent report assessing the childs pain sleep and psycho-social variables QST will assess pain inhibition via conditioned pain modulation CPM and pain facilitation via temporal summation TS
Study participation will consist of a baseline assessment a 5 session once per week virtual group cognitive behavioral therapy for insomnia CBT-I intervention and a follow-up assessment Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits Assessment visits will consist of two types of assessments questionnaires and quantitative sensory testing QST Participating parents and teens will complete questionnaires both child and parent report assessing the childs pain sleep and psycho-social variables QST will assess pain inhibition via conditioned pain modulation CPM and pain facilitation via temporal summation TS
Detailed Description:
None
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