Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373718
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Sleep Mechanisms of Regulating Emotions
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety R33 Phase
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:
SleepMORE
Brief Summary:
This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention Cognitive Behavioral Therapy for Insomnia CBT-I on engagement of the emotion regulation brain network as a putative mechanistic target
Detailed Description:
Several lines of evidence suggest that insomnia contributes to emotionally distressing depressive mood symptoms through disruption of brain networks that regulate emotional functions Of particular concern insomnia is associated with an increased risk for suicide even when accounting for the presence of other depressive symptoms However it is not yet know to what degree that the emotion regulation brain network is modified by the restoration of sleep or whether the degree to which a sleep intervention engages these neural targets mediates reductions in depressive symptoms and suicidality
This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention Cognitive Behavioral Therapy for Insomnia CBT-I on engagement of the emotion regulation brain network as a putative mechanistic target
This project aims to extend the initial findings from the first phase IRB-56961 to 1 confirm target engagement defined as the treatment effect on increasing mPFC-amygdala connectivity andor decreasing amygdala reactivity during emotion reactivity and regulation paradigms by testing the hypothesis that compared with a control condition CBT-I participants will show significant change in the emotion regulation network targets that met the Go Criteria of the first phase in the direction of normalization at the end of treatment 2 examine the relationships of target engagement to treatment outcomes by study group and 3 test whether emotion regulation network measures at baseline predict depressive symptom and suicidality reduction
Participants will be 150 adults experiencing at least moderate sleep disturbances and who also have elevated anxious andor depressive symptoms Eligible participants will be randomized into either the Immediate Treatment group which will receive six sessions of CBT-I over the eight weeks of treatment phase immediately after randomization or the Enhanced Sleep Hygiene group which will be provided with two sessions of sleep hygiene sleep education and four additional meetings including monitoring of sleep and mood symptoms and will be offered the same CBT-I as the Immediate Treatment group upon completion of the 6-month follow-up session approximately 7 months after randomization Emotion distress and sleep disruption will be assessed prior to and weekly during the eight weeks of treatment phase CBT-I improves sleep patterns through a combination of sleep restriction stimulus control mindfulness training cognitive therapy targeting dysfunctional beliefs about sleep and sleep hygiene education Using fMRI scanning emotion regulation network neural targets will be assayed prior to and following completion of CBT-I treatment
This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention Cognitive Behavioral Therapy for Insomnia CBT-I on engagement of the emotion regulation brain network as a putative mechanistic target
This project aims to extend the initial findings from the first phase IRB-56961 to 1 confirm target engagement defined as the treatment effect on increasing mPFC-amygdala connectivity andor decreasing amygdala reactivity during emotion reactivity and regulation paradigms by testing the hypothesis that compared with a control condition CBT-I participants will show significant change in the emotion regulation network targets that met the Go Criteria of the first phase in the direction of normalization at the end of treatment 2 examine the relationships of target engagement to treatment outcomes by study group and 3 test whether emotion regulation network measures at baseline predict depressive symptom and suicidality reduction
Participants will be 150 adults experiencing at least moderate sleep disturbances and who also have elevated anxious andor depressive symptoms Eligible participants will be randomized into either the Immediate Treatment group which will receive six sessions of CBT-I over the eight weeks of treatment phase immediately after randomization or the Enhanced Sleep Hygiene group which will be provided with two sessions of sleep hygiene sleep education and four additional meetings including monitoring of sleep and mood symptoms and will be offered the same CBT-I as the Immediate Treatment group upon completion of the 6-month follow-up session approximately 7 months after randomization Emotion distress and sleep disruption will be assessed prior to and weekly during the eight weeks of treatment phase CBT-I improves sleep patterns through a combination of sleep restriction stimulus control mindfulness training cognitive therapy targeting dysfunctional beliefs about sleep and sleep hygiene education Using fMRI scanning emotion regulation network neural targets will be assayed prior to and following completion of CBT-I treatment
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