DepressionTEAM-RedNCT05488782

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

A study testing TEAM-Red and Waitlist in people with Depression, run by Jennifer B. Levin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 49 years, women only
Conditions the study is for: Depression
What is being tested?: TEAM-Red and Waitlist
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2023to 18 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
No healthy volunteers
Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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)

Conditions: Depression
Being tested: TEAM-Red, Waitlist
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TEAM-RedBehavioural
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
WaitlistOther
After the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention

Study groups in NCT05488782
Study group	Role	What they receive
TEAM-Red	Experimental	Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference Receives: Behavioral: TEAM-Red
Enhanced Waitlist (eWL)	Other	After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention Receives: Other: Waitlist

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 TEAM vs WL change in 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 12 weeks
Phase 1 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 9-item Patient Health Questionnaire (PHQ-9) total score at 12-week follow-up
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 12 weeks
Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow-up
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 12 weeks
Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 24 weeks

Secondary outcomes (18)

Phase 1 TEAM-Red vs eWL 10-item Perceived Stress Scale (PSS-10) total score at 12-week follow-up
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 12 weeks
Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 24 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) mental component score at 12-week follow up
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
Measured: Baseline to 12 weeks
Phase 1 TEAM-Red vs eWL 12-item Short Form Survey (SF-12) physical component score at 12-week follow up
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
Measured: Baseline to 12 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
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
Measured: Baseline to 24 weeks
Phase 1 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
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
Measured: Baseline to 24 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) mental component score at 12-week follow-up
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
Measured: Baseline to 12 weeks
Phase 2 TEAM-Red vs eWL change in 12-item Short Form Survey (SF-12) physical component score at 12-week follow-up
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
Measured: Baseline to 12 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
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
Measured: Baseline to 24 weeks
Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
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
Measured: Baseline to 24 weeks
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
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 12 weeks
Phase 1 and Phase 2 change in 9-item Patient Health Questionnaire (PHQ-9) total score at 24-week follow up
PHQ-9 total score ranges from 0 to 27, with a higher score indicating a higher level depression
Measured: Baseline to 24 weeks
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
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 12 weeks
Phase 1 and Phase 2 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
PSS-10 total scores ranges from 0 to 40 with a higher score indicating a higher level of perceived stress
Measured: Baseline to 24 weeks
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
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
Measured: Baseline to 12 weeks
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
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
Measured: Baseline to 12 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) mental component score at 24-week follow up
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
Measured: Baseline to 24 weeks
Phase 1 and Phase 2 change in 12-item Short Form Survey (SF-12) physical component score at 24-week follow up
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
Measured: Baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202318 Sep 2025

First posted5 Aug 2022
Study start30 Jan 2023
Primary completion18 Sep 2025
Study completion18 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: 41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05488782
Sponsor's protocol ID: STUDY20220976
Acronym: TEAM-Red
Status last verified: Aug 2025
First submitted: 3 Aug 2022
Last updated: 28 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05488782
Acronym / sponsor ID: TEAM-Red / STUDY20220976
Conditions: Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Jennifer B. LevinUniversity, hospital or other
Collaborators: American Heart Association
Study start: 30 Jan 2023 (actual)
Primary completion: 18 Sep 2025 (actual)
Study completion: 18 Sep 2025 (actual)
First posted: 5 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 41 participants are assigned to receive TEAM, and 41 participants are assigned to wait list

Arm	Type	Receives
TEAM-Red	Experimental	Behavioral: TEAM-RedFive 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Enhanced Waitlist (eWL)	Other	Other: WaitlistAfter the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TEAM-RedFive 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference	Behavioural	TEAM-Red
WaitlistAfter the week 12 follow up visits subjects in the Waitlist group will receive the TEAM Red intervention	Other	Enhanced Waitlist (eWL)

Primary outcome

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
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
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
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
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
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

18 secondary outcomes

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
Phase 1 change in 10-item Perceived Stress Scale (PSS-10) total score at 24-week follow up
Time frame: Baseline to 24 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Individual participant dataSharing planned: Yes. Deidentified data with the data dictionary and protocol will be made available to other researchers via the American Heart Association (AHA) Precision Medicine Platform

Related trials for Depression

Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Levin principal investigator

University Hospitals Cleveland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TEAM-Red and Waitlist in people with Depression, run by Jennifer B. Levin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.