Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03013907
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2017-01-05
Brief Title:
Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension EASE Study
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension EASE Study
Status:
COMPLETED
Status Verified Date:
2019-11
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:
The purpose of this study is to adapt and then evaluate the feasibility acceptability and efficacy of a telephone-based intervention UPLIFT Using Practice and Learning to Increase Favorable Thoughts for individuals with elevated depressive symptoms and hypertension UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hourweek by phone
Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual interviews and to test the adapted UPLIFT program in a single-arm design Aim 2 of this study is a randomized controlled trial RCT that will compare the effects of the adapted UPLIFT program to usual care UC and to test mediators and moderators of the effects of UPLIFT
Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual interviews and to test the adapted UPLIFT program in a single-arm design Aim 2 of this study is a randomized controlled trial RCT that will compare the effects of the adapted UPLIFT program to usual care UC and to test mediators and moderators of the effects of UPLIFT
Detailed Description:
Once 16 participants are enrolled to form 2 groups of 8 patients each an independent study staff member will determine participants group assignments The randomization sequence will be created a priori by Dr Keith Goldfeld biostatistician by using a computer-generated list of random numbers with stratification by antidepressant medication use and baseline levels of depressive symptoms PHQ scores 10 and 10
UPLIFT Eligible participants will complete 8 weekly group sessions by phone The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms Each hour-long weekly session consists of check-in instruction skill building discussion and a home-based practice assignment
Usual care Subjects randomized to UC will be advised to seek help from their primary care physician PCP or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study All treatments received over the course of the study for the UC group and outside of the study for the intervention group will be assessed at each time point
UPLIFT Eligible participants will complete 8 weekly group sessions by phone The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms Each hour-long weekly session consists of check-in instruction skill building discussion and a home-based practice assignment
Usual care Subjects randomized to UC will be advised to seek help from their primary care physician PCP or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study All treatments received over the course of the study for the UC group and outside of the study for the intervention group will be assessed at each time point
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