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TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension

Sponsor
Jennifer B. Levin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05488782
Collaborator
American Heart Association (Other)
50
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=25) vs. enhanced wait-list (eWL, N=25) control in depressed young (≤50 years) African-American (AA) women at risk for hypertension.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TEAM-Red
  • Other: Waitlist
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
25 participants are assigned to receive TEAM, and 25 participants are assigned to wait list25 participants are assigned to receive TEAM, and 25 participants are assigned to wait list
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEAM-Red

Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference

Behavioral: TEAM-Red
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Other: Enhanced Waitlist (eWL)

After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention

Other: Waitlist
After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

Outcome Measures

Primary Outcome Measures

  1. TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score [Baseline to 12 weeks]

    PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression

  2. TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score [Baseline to 24 weeks]

    PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Registered on Research Goes Red;

  2. Self-identified AA female ages 18-49;

  3. current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),

  4. Have at least one of the following self or chart-recorded HTN risk factors: body mass index (BMI) greater ≥ 30, HbA1c >5.75, at least one outpatient reading of systolic blood pressure (BP) ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;

  5. Are able to participate in study procedures.

Exclusion Criteria:

  1. Unwilling/unable to provide informed consent;

  2. Pregnancy;

  3. Imminent suicide risk,

  4. A current diagnosis of hypertension or use of antihypertensive medications.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Jennifer B. Levin
  • American Heart Association

Investigators

  • Principal Investigator: Jennifer Levin, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer B. Levin, Principal Investiagator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT05488782
Other Study ID Numbers:
  • STUDY20220976
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Aug 16, 2022