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

Primary Purpose

Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TEAM-Red

Waitlist

About this trial

This is an interventional other trial for Depression

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Registered on Research Goes Red;
Self-identified AA female ages 18-49;
current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
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;
Are able to participate in study procedures.

Exclusion Criteria:

Unwilling/unable to provide informed consent;
Pregnancy;
Imminent suicide risk,
A current diagnosis of hypertension or use of antihypertensive medications.

Sites / Locations

University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TEAM-Red

Enhanced Waitlist (eWL)

Arm Description

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

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

Outcomes

Primary Outcome Measures

TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score

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

TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05488782

First Posted

August 3, 2022

Last Updated

January 30, 2023

Sponsor

Jennifer B. Levin

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT05488782

Brief Title

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

Acronym

TEAM-Red

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 30, 2023 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jennifer B. Levin

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

25 participants are assigned to receive TEAM, and 25 participants are assigned to wait list

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TEAM-Red

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Waitlist (eWL)

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

TEAM-Red

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Waitlist

Intervention Description

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

Primary Outcome Measure Information:

Title

TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score

Description

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

Time Frame

Baseline to 12 weeks

Title

TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score

Description

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

Time Frame

Baseline to 24 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

participant eligibility is based on self-representation of gender identity.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Registered on Research Goes Red; Self-identified African American female ages 18-49; current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9), 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; Are able to participate in study procedures. Exclusion Criteria: Unwilling/unable to provide informed consent; Pregnancy; Imminent suicide risk, A current diagnosis of hypertension or use of antihypertensive medications.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taylor Maniglia

Phone

888-819-0004

Taylor.Maniglia@UHhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Levin

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taylor Maniglia

Phone

888-819-0004

First Name & Middle Initial & Last Name & Degree

Jenniger Levin, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform

IPD Sharing Time Frame

Data will be available by one year following the funding

Learn more about this trial

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

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