Self-Management Program for Depression and High Blood Pressure Risk

(TEAM-Red Trial)

Overseen By Taylor Maniglia

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Jennifer B. Levin

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Hypertension, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

82 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using antihypertensive medications (medications for high blood pressure).

What data supports the effectiveness of the treatment TEAM-Red for managing depression and high blood pressure risk?

Research shows that integrating depression treatment into hypertension care can improve both blood pressure control and depressive symptoms. Additionally, self-management programs and interventions that consider social factors have been effective in improving health outcomes for patients with both conditions. ^{1 2 3 4 5}

Is the Self-Management Program for Depression and High Blood Pressure Risk safe for humans?

The available research does not provide specific safety data for the Self-Management Program for Depression and High Blood Pressure Risk, but similar team-based care programs for managing hypertension and depression have been implemented without reported safety concerns. ^{6 7 8 9 10}

How is the TEAM-Red treatment different from other treatments for depression and high blood pressure?

TEAM-Red is unique because it integrates depression treatment into hypertension care, using a team-based approach involving Licensed Practical Nurses (LPNs) to improve both blood pressure control and depressive symptoms, unlike traditional treatments that often address these conditions separately. ^{1 3 8 11 12}

Research Team

Jennifer Levin, PhD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for young African-American women under 50 with depression and at risk for high blood pressure, but not yet diagnosed with it. Participants must have a BMI ≥30, HbA1c >5.75, a recent BP reading of ≥130/90 mmHg, be current smokers or have LDL levels ≥100 mg/dl.

Inclusion Criteria

I have high blood pressure risk due to factors like being overweight, high blood sugar, high blood pressure readings, smoking, or high cholesterol.

I can follow the study's required procedures.

You have a score of 10 or more on the 9-item Patient Health Questionnaire (PHQ-9), which measures depression.

Exclusion Criteria

I have high blood pressure or am taking medication for it.

Unwilling/unable to provide informed consent

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TEAM-Red intervention or are placed on an enhanced waitlist control for 24 weeks

24 weeks

5 group sessions (remote)

Follow-up

Participants are monitored for changes in depression and stress levels using PHQ-9 and PSS-10 scores

12 weeks

Treatment Details

Interventions

• TEAM-Red
• Waitlist

Trial Overview The study compares the TEAM-Red self-management program against an enhanced waitlist control over 24 weeks to see if it helps manage risks associated with hypertension in depressed Black women who are predisposed to high blood pressure.

Participant Groups

Group I: TEAM-Red Experimental Treatment 1 Intervention

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

Group II: Enhanced Waitlist (eWL) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Jennifer B. Levin

Lead Sponsor

Trials

1

Recruited

80+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

An integrated care intervention led by Licensed Practical Nurses (LPNs) significantly improved blood pressure control and reduced depressive symptoms in patients with hypertension, with diastolic blood pressure dropping from 82.0 mmHg in usual care to 74.2 mmHg in the intervention group after 12 weeks.

Patients receiving the integrated care also showed a notable decrease in depressive symptoms, with average PHQ-9 scores improving from 7.1 in usual care to 2.4 in the intervention group, highlighting the effectiveness of combining depression treatment with hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of a licensed practical nurse intervention for hypertension and depression. Bogner, HR., de Vries, HF., Kaye, EM., et al.[2022]

Self-management interventions significantly improve patient activation levels in adults with hypertension, based on a systematic review of 4 studies involving 1415 participants.

Strategies such as community-based programs and motivational interviewing were particularly effective, leading to better patient activation measure (PAM) scores compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Behavioral Interventions on Patient Activation in Adults with Hypertension: A Systematic Review and Meta-Analysis. Innab, A., Kerari, A.[2022]

In a study of 318 patients with primary hypertension, self-efficacy was found to be a key mediator between social support and self-care behaviors related to diet and weight management, highlighting its importance in managing hypertension.

Depressive symptoms also played a significant role, mediating the relationship between social support and self-efficacy, suggesting that addressing mental health is crucial for improving self-care in hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing self-care among patients with primary hypertension: path analysis of mediating roles of self-efficacy and depressive symptoms. Chen, TY., Kao, CW., Cheng, SM., et al.[2023]

In a pilot trial involving 54 patients, an integrated intervention that considered social determinants of health led to significant improvements in depressive symptoms, as measured by the PHQ-9, compared to a basic intervention after 12 weeks (p = 0.024).

The enhanced intervention also resulted in significant reductions in both systolic and diastolic blood pressure compared to the basic intervention, indicating that addressing social factors can improve both mental and physical health outcomes (p = 0.003 for systolic and p = 0.019 for diastolic).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Patients' Social Determinants of Health into Hypertension and Depression Care: A Pilot Randomized Controlled Trial. McClintock, HF., Bogner, HR.[2022]

The 'hospital-community-family' integrated management approach significantly improved nursing satisfaction among hypertensive patients, achieving a 100% satisfaction rate compared to 83.33% in the control group.

This integrated management also led to better blood pressure control, lower anxiety and depression scores, and higher disease awareness rates, indicating its effectiveness in enhancing overall patient management and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of "Hospital-Community-Family" Integrated Management on Blood Pressure, Quality of Life, Anxiety and Depression in Hypertensive Patients. Shi, W., Cheng, L., Li, Y.[2022]

Project ReD CHiP is a multi-level quality improvement initiative designed to address racial disparities in blood pressure control by implementing three complementary interventions across six primary care clinics in Baltimore, Maryland.

The study aims to demonstrate that combining interventions targeting blood pressure measurement, patient care management, and provider education will lead to greater improvements in hypertension care and reductions in disparities compared to any single intervention alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol. Cooper, LA., Marsteller, JA., Noronha, GJ., et al.[2022]

The Hypertension Management Program (HMP) was successfully adapted and implemented in a federally qualified health center in South Carolina, involving clinical pharmacists in managing hypertension for 316 patients through 758 visits, demonstrating its effectiveness in improving hypertension control.

The total cost of the HMP was $325,532, averaging $3.62 per patient per month, indicating that a team-based, patient-centered approach can be both cost-effective and beneficial in resource-limited settings for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Approach for Evaluating Implementation Processes and Program Costs for a Hypertension Management Program Implemented in a Federally Qualified Health Center. Tucker-Brown, A., Spafford, M., Wittenborn, J., et al.[2023]

Physicians generally had a positive attitude towards team care, which was influenced by factors such as communication, access, trust, and the perceived competency of team members, highlighting the importance of these elements in effective healthcare delivery.

Individual practice styles significantly affected how physicians engaged with team care, suggesting that tailoring team approaches to fit different physician styles could enhance the effectiveness of care management programs for patients with uncontrolled hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care physician perspectives on using team care in clinical practice. Beran, M., Bergdall, AR., Kodet, AJ., et al.[2021]

The technology-assisted collaborative care (TCC) program showed potential efficacy in treating depression among 20 patients with diabetes and/or high blood pressure, with two-thirds responding positively to treatment after 12 weeks.

Participants reported decreased depressive symptoms, fewer healthcare visits, and improved mental health-related quality of life, indicating that the TCC program is a promising approach for managing depression in patients with chronic physical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Assisted Collaborative Care Program for People with Diabetes and/or High Blood Pressure Attending Primary Health Care: A Feasibility Study. Martínez, P., Guajardo, V., Gómez, VE., et al.[2021]

Hypertension self-management classes at Lincoln Community Health Center significantly reduced blood pressure among participants, particularly Black men, with an average reduction of 19.1/14.8 mm Hg for those attending multiple classes.

Despite the effectiveness of these classes in improving hypertension control, challenges related to health insurance reimbursement and federal quality reporting standards limit the implementation of such educational initiatives in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Hypertension Self-Management Classes Among Patients at a Federally Qualified Health Center. Eck, C., Biola, H., Hayes, T., et al.[2022]

The Hypertension Self-care Profile was successfully translated into Chinese (HBP SCP-C) and demonstrated strong psychometric properties, including high reliability with Cronbach α coefficients of 0.86 to 0.94 and test-retest reliability ranging from 0.81 to 0.98 among 200 Chinese patients with hypertension.

The HBP SCP-C effectively distinguishes between patients with and without comorbidities in terms of self-care behaviors, motivation, and self-efficacy, confirming its validity as a tool for assessing hypertension self-care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Evaluation of the Chinese Version of Hypertension Self-care Profile. Ma, Y., Cheng, HY., Sit, JWH., et al.[2021]

The TBC-HTA study is evaluating a team-based care intervention involving nurses, pharmacists, and physicians to improve blood pressure control in 110 hypertensive outpatients over a 6-month period, compared to usual care.

The primary goal is to assess the difference in daytime ambulatory blood pressure between the team-based care group and the usual care group, with secondary outcomes including patient and healthcare professional satisfaction and long-term blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. Santschi, V., Wuerzner, G., Chiolero, A., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot trial of a licensed practical nurse intervention for hypertension and depression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Behavioral Interventions on Patient Activation in Adults with Hypertension: A Systematic Review and Meta-Analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Factors influencing self-care among patients with primary hypertension: path analysis of mediating roles of self-efficacy and depressive symptoms. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Incorporating Patients' Social Determinants of Health into Hypertension and Depression Care: A Pilot Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Influence of "Hospital-Community-Family" Integrated Management on Blood Pressure, Quality of Life, Anxiety and Depression in Hypertensive Patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Approach for Evaluating Implementation Processes and Program Costs for a Hypertension Management Program Implemented in a Federally Qualified Health Center. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Primary care physician perspectives on using team care in clinical practice. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Technology-Assisted Collaborative Care Program for People with Diabetes and/or High Blood Pressure Attending Primary Health Care: A Feasibility Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Hypertension Self-Management Classes Among Patients at a Federally Qualified Health Center. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Psychometric Evaluation of the Chinese Version of Hypertension Self-care Profile. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]