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Not recruiting

Self-management Program

Sponsor:

Jennifer B. Levin

Code:

NCT05488782

Conditions

Depression

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

TEAM-Red

Waitlist

Study Details

Brief summary:

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.

Conditions

Depression

Study ID

NCT05488782

Start date

Jan 30, 2023

Status verified date

Oct, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jan 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

Phase 1 Inclusion Criteria:

1. Registered on Research Goes Red;
2. Self-identified African American 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.

Phase 1 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.

Phase 2 Inclusion Criteria

1. Self-identified AA female ages 18-49;
2. 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
3. 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;
4. Are able to participate in study procedures.

Phase 2 Exclusion Criteria

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

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

TEAM-Red

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

Waitlist

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

Primary outcome measure

  • 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 ]
  • Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up [ Time Frame: Baseline to 24 weeks ]
  • 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 ]
  • Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up [ Time Frame: Baseline to 24 weeks ]
  • 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 ]
  • Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up [ Time Frame: Baseline to 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Taylor Maniglia

888-819-0004

Principal Investigator:

Jennifer Levin, PhD

More Information

Sponsor

Jennifer B. Levin

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jennifer B. Levin on 2024-10-08.