Adapting Project UPLIFT for Blacks in Georgia
Adapting Evidence-Based Epilepsy Self-Management Programs for Blacks in Georgia
1 other identifier
interventional
82
1 country
1
Brief Summary
Evaluate the efficacy of Project UPLIFT for reducing symptoms of depression and anxiety among African Americans at immediate posttest and after 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2016
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJune 23, 2020
June 1, 2020
3.1 years
September 19, 2016
June 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Modified Beck Depression Inventory
Measure of depressive symptoms over previous two weeks.
Post intervention (8 weeks)
Beck Anxiety Inventory
Measure of anxiety symptoms over previous week.
Post intervention (8 weeks)
Secondary Outcomes (2)
Modified Beck Depression Inventory
3-months Post Intervention
Beck Anxiety Inventory
3-months Post intervention
Study Arms (2)
Stratum A
EXPERIMENTALThis group will be the first to receive the Project UPLIFT intervention, a distance-delivered mindfulness-based cognitive therapy intervention. The intervention is conducted by phone for one hour once a week for 8 weeks.
Stratum B
ACTIVE COMPARATORThis group will also receive the Project UPLIFT intervention at crossover, after a 10-week waiting period.
Interventions
UPLIFT is an 8-week distance-delivered mindfulness-based cognitive therapy intervention.
Eligibility Criteria
You may qualify if:
- Identify as African American or Black;
- Diagnosed by a healthcare provider with epilepsy or seizure disorder at least 3 months ago;
- Is mildly to moderately depressed or mildly to moderately anxious as determined by the PHQ-4;
- Willing to be audio-recorded during UPLIFT sessions
You may not qualify if:
- Reports suicidal ideation within the past month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morehouse School of Medicinelead
- Emory Universitycollaborator
Study Sites (1)
Morehouse School of Medicine
Atlanta, Georgia, 30310-1495, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rakale C Quarells, PhD
Morehouse School of Medicine
- PRINCIPAL INVESTIGATOR
Nancy Thompson, PhD, MPH
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 21, 2016
Study Start
September 8, 2016
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
June 23, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be made available by December 2019. Data will remain with the MEW Network database indefinitely.
- Access Criteria
- Access to data will be through the MEW Network database steering board.
De-identified participant data will be shared with the Managing Epilepsy Well Network (MEW) database.