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Completed

NCT Number: NCT05488782

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

The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=41) vs. enhanced waitlist (eWL, N=41) control in young (<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Phase 1 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.

Phase 1 Exclusion Criteria:

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

Phase 2 Inclusion Criteria

  • Self-identified AA female ages 18-49;
  • Endorses either: a past or current history of depression, current depression as measured by a score of at least a 5 on the 9-item Patient Health Questionnaire (PHQ-9), or indicate feelings of stress or discrimination that impact their functioning
  • Have at least one of the following self or chart-recorded HTN risk factors: BMI greater ≥ 30,26 HbA1c >5.75,27 at least one outpatient reading of systolic 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.

Phase 2 Exclusion Criteria

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

Treatment and study plan

TEAM-Red

Behavioral

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

Waitlist

Other

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

Primary outcomes

  1. Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

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

  2. Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up

    Time frame: Baseline to 24 weeks

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

  3. Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

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

  4. Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up

    Time frame: Baseline to 24 weeks

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

  5. Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

  6. Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up

    Time frame: Baseline to 24 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

Secondary outcomes

  1. Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

  2. Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up

    Time frame: Baseline to 24 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

  3. Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up

    Time frame: Baseline to 12 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  4. Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up

    Time frame: Baseline to 12 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

  5. Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  6. Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

  7. Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  8. Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

  9. Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  10. Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

  11. Phase 1 and Phase 2 TEAM-Red vs eWL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

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

  12. Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up

    Time frame: Baseline to 24 weeks

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

  13. Phase 1 and Phase 2 TEAM-Red vs eWL change in 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

  14. Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up

    Time frame: Baseline to 24 weeks

    PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress

  15. Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  16. Phase 1 and Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up

    Time frame: Baseline to 12 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

  17. Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 mental component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to mental health

  18. Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up

    Time frame: Baseline to 24 weeks

    SF-12 physical component score ranges from 0 to 100, with higher scores indicating a better quality of life as it relates to physical health

Sponsors and collaborators

Lead sponsor

Jennifer B. Levin

Other

Collaborators

  • American Heart Association

Registry information

Official study title

A Pilot RCT of a Remotely Delivered Self-management Program (TEAM-Red) for Depressed Young African American Women at Risk for Hypertension (HTN)

Acronym: TEAM-Red

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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