Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359314
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-02
Brief Title:
Anxiety Lowering and Deprescribing Through Emotion Regulation
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults Anxiety Lowering and Deprescribing Through Emotion Regulation ALDER
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
ALDER
Brief Summary:
The goal of this clinical trial is to test ALDER Anxiety Lowering and Deprescribing through Emotion Regulation an online self-guided positive emotion intervention in patients over the age of 65 who are candidates for benzodiazepine receptor agonist BZRA commonly called benzos or z-drugs deprescribing The main questions it aims to answer are
Is ALDER relevant to and satisfactory for older adult BZRA users
Does ALDER help to increase positive emotions and decrease anxiety trouble sleeping and use of BZRA medications
Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments one before the intervention and one after
Is ALDER relevant to and satisfactory for older adult BZRA users
Does ALDER help to increase positive emotions and decrease anxiety trouble sleeping and use of BZRA medications
Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments one before the intervention and one after
Detailed Description:
ALDER Anxiety Lowering and Deprescribing through Emotion Regulation is a pilot trial of an online positive emotion intervention for adults age 65 and over who are candidates for benzodiazepine receptor agonist BZRA deprescribing The ALDER intervention is 5 weeks long and involves weekly self-guided positive emotion skill lessons and daily skill practice exercises both housed on the ALDER website
Up to n40 patients over the age of 65 will be recruited from Northwestern Medicine Primary Care clinics To participate patients must have 1 a BZRA prescription from Northwestern Medicine Primary Care within the past year 2 at least 1 NM Primary Care visit in the past year and 3 take a BZRA at least twice a week Participants will complete survey assessments via REDCap before and after they go through the ALDER intervention All study activities will take place online
Feasibility acceptability and adoption of the ALDER program will be assessed using enrollment and retention rates website user data and measures of relevance and satisfaction in the post-intervention assessment Patient reported outcomes such as anxiety sleep and positive affect will be measured both pre- and post-intervention and rate of BZRA usage will be extracted from participant medical records
Up to n40 patients over the age of 65 will be recruited from Northwestern Medicine Primary Care clinics To participate patients must have 1 a BZRA prescription from Northwestern Medicine Primary Care within the past year 2 at least 1 NM Primary Care visit in the past year and 3 take a BZRA at least twice a week Participants will complete survey assessments via REDCap before and after they go through the ALDER intervention All study activities will take place online
Feasibility acceptability and adoption of the ALDER program will be assessed using enrollment and retention rates website user data and measures of relevance and satisfaction in the post-intervention assessment Patient reported outcomes such as anxiety sleep and positive affect will be measured both pre- and post-intervention and rate of BZRA usage will be extracted from participant medical records
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