Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335485
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-06-23
Brief Title:
Cognitive Behavioral Therapy CBT Pain Prevention Intervention for Women Undergoing Surgery
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
This study investigates a Cognitive Behavioral Therapy CBT intervention for women who are undergoing elective surgery The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery
Detailed Description:
The Investigators are doing this research to understand whether a pre-surgery virtual cognitive behavioral therapy CBT group intervention combined with an activity tracker can reduce pain and opioid use in women with chronic stress undergoing elective spine surgery
Participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual CBT group sessions designed to improve reactions to stress increase motivation for physical activity develop tools for managing pain and utilize mindfulness techniques Two optional sessions will be available following surgery Individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an App to track their pain and medication use
The ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications
Participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual CBT group sessions designed to improve reactions to stress increase motivation for physical activity develop tools for managing pain and utilize mindfulness techniques Two optional sessions will be available following surgery Individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an App to track their pain and medication use
The ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications
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