Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506253
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Massage for GAD Neuroimaging and Clinical Correlates of Response
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Massage for GAD Neuroimaging and Clinical Correlates of Response
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety
This is a randomized research study and subjects will be randomized into one of two study touch intervention groups and will have an equal chance of being placed in one of the groups
1 Swedish massage therapy twice per week for 6 weeks
2 Light touch therapy twice per week for 6 weeks
The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder
Subjects will undergo two fMRI scanning sessions one before and one after twice per week for 6 weeks of touch intervention Subjects will also be asked to complete questionnaires on anxiety stress and depression
This is a randomized research study and subjects will be randomized into one of two study touch intervention groups and will have an equal chance of being placed in one of the groups
1 Swedish massage therapy twice per week for 6 weeks
2 Light touch therapy twice per week for 6 weeks
The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder
Subjects will undergo two fMRI scanning sessions one before and one after twice per week for 6 weeks of touch intervention Subjects will also be asked to complete questionnaires on anxiety stress and depression
Detailed Description:
This is a two-arm randomized single masked study investigating the effects of Swedish massage therapy SMT vs a light touch LT control on brain activity clinical response and autonomic function in subjects with Generalized Anxiety Disorder GAD
Primary Objective
To identify brain networks activated by SMT vs LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD Primary endpoint Pre-to-post-treatment change in resting state functional connectivity
Secondary Objectives
To correlate pre-to-post-treatment change in rsFC with changes in anxiety scores HAM-A within both treatment groups Secondary Endpoints Pre-to-post-treatment change in response to fearfulangry faces task and clinical response on the HAM-A
To correlate changes in autonomic measures with clinical response and rsFC Secondary Endpoint Autonomic activity heart rate variability heart rate pulse
Exploratory Objectives To evaluate whether SMT improves stress depression and global functioning more than LT Exploratory Endpoints Change in Perceived Stress Perceived Stress Scale depression Quick Inventory of Depressive Symptomatology QIDS-SR and global functioning Clinical Global Impression-SI from baseline to post intervention at week 6
Primary Objective
To identify brain networks activated by SMT vs LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD Primary endpoint Pre-to-post-treatment change in resting state functional connectivity
Secondary Objectives
To correlate pre-to-post-treatment change in rsFC with changes in anxiety scores HAM-A within both treatment groups Secondary Endpoints Pre-to-post-treatment change in response to fearfulangry faces task and clinical response on the HAM-A
To correlate changes in autonomic measures with clinical response and rsFC Secondary Endpoint Autonomic activity heart rate variability heart rate pulse
Exploratory Objectives To evaluate whether SMT improves stress depression and global functioning more than LT Exploratory Endpoints Change in Perceived Stress Perceived Stress Scale depression Quick Inventory of Depressive Symptomatology QIDS-SR and global functioning Clinical Global Impression-SI from baseline to post intervention at week 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None