Mobile Stress Management Program for African American Women

Reducing Health Disparities Among African American Women: A Mobile Cognitive Behavioral Stress Management Intervention

The unjust social, economic, and environmental conditions that African Americans face throughout their lives lead to pervasive health disparities. These disparities are driven by healthcare differences. They are driven by economic differences. Those with less financial wealth have poorer health as compared to those with higher socioeconomic status. And yet, even when controlling for these two important social determinants of health, race still predicts morbidity and mortality.

What can account for this? Stress. African Americans experience more stress than their White peers. The story is even more dire for African American women who simultaneously face both racial discrimination and sexism. Indeed, gendered racial discrimination is nearly ubiquitous for Black women at all socioeconomic levels. It is also a distinct form of stress, with unique outcomes compared to other non-race-or-gender-related stressors. Finally, stress has clear downstream negative effects on health.

At present, there is no mobile cognitive-behavioral stress management intervention (m-CBSMi) designed to help African American women manage racial and nonracial daily stress. The investigators intend to fill this void. Using proven CBSMi techniques, participants will learn how to manage their stress through text messages and integrated mobile web content. Supportive texts will inspire, motivate, and affirm the life experiences of participants. Educational texts will increase knowledge, develop skills, and reduce barriers to adaptive coping. A library of individually tailored videos will be delivered to each participant. All mobile web content will be accessible only through touch-based links embedded within text messages, making it easy and effortless to view this material.

During Phase II the investigators will complete development of the m-CBSMi. Then, the investigators will examine the effectiveness of the m-CBSMi to reduce stress among African American female participants. Participants will be randomly assigned to either the intervention condition or to a matched control condition. Secondary measures will assess coping, well-being, subjective health, gendered racial identity, and knowledge.

Study Overview

• Status: Recruiting
• Conditions: Psychological Stress
• Intervention / Treatment: Behavioral: Mobile cognitive-behavioral stress management intervention; Behavioral: Control

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Douglas Billings, PhD; Phone Number: 3 7037390880; Email: dbillings@isagroup.com

Study Locations

• United States
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Recruiting
      • ISA Associates
      • Contact: Douglas Billings, PhD; Phone Number: 3 7037390880; Email: dbillings@isagroup.com
      • Contact: Mary Morcos, MPH; Phone Number: 703-264-7223; Email: mmorcos@isagroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• self-identify as Black; own a smartphone; have at least limited English literacy skills; report perceived discrimination; and be moderately stressed. The discrimination must be due to race or gender and the frequency must be at least "a few times in the past year" or more. In addition, they must report a score of 6 or higher on the 4-item Perceived Stress Scale (PSS).

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; All 11 modules will include the following elements: introduction to the topic; two types of assessments (1) adherence to at-home relaxation training practice (following week 2) and (2) 3-5 topic-specific questions to tailor video-based content; a cognitive component; a relaxation component; and a wrap up that includes a brief assessment of module comprehension. Each user will view 5-7 videos per module. Videos will be tailored to user and will last between 2 and 4 minutes. Total time per module will be 20 to 30 minutes. Between modules, users will receive (based on their timing preferences) supportive texts intended to motivate continued engagement or to affirm the life experiences of African American women	Behavioral: Mobile cognitive-behavioral stress management intervention; Each weekly module will consist of a cognitive component and a relaxation component. The cognitive component during the first 3 weeks will educate users about the Transactional Model of Stress, that discrimination is a type of stressor, and the impact of stress on health. Building on this information, users will then learn how to match coping responses to the changeability of stressors during weeks 4 and 5. The cognitive component will conclude by focusing on the four most common coping strategies used by African American women in response to stress. Modules 2 through 4 will teach progressive muscle relaxation through a series of tension and relaxation cycles. Modules 5 through 8 will train users in diaphragmatic breathing. Finally, users will be trained in three types of mindfulness mediations.
Active Comparator: Control; Two mobile courses: Introduction to Stress Management and Techniques for Coping with Stress. Users will be informed that the courses will be completed on their phone, that they are video-based, and that they should spend between 20 and 30 minutes each week, for the next 11 weeks, learning the material. The introductory course defines stress, describes the different sources of stress, and the influence of personality on stress. The coping module includes training in cognitive coping skills, guided imagery, progressive relaxation, autogenic training, and the importance of physical activity to manage stress. All lessons include course assessments. During the intervention period, controls will receive weekly text messages encouraging completion of material.	Behavioral: Control; The introductory course defines stress, describes the different sources of stress, and the influence of personality on stress. The coping module includes training in cognitive coping skills, guided imagery, progressive relaxation, autogenic training, and the importance of physical activity to manage stress. All lessons include course assessments. During the intervention period, controls will receive weekly text messages encouraging completion of material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Stress on the 10-point Perceived Stress Scale at Week 24	10-item survey that measures the degree to which an individual perceives his/her life as uncontrollable, unpredictable, and overwhelming	Baseline and Week 24

Collaborators and Investigators

• Sponsor: ISA Associates, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: MD014077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The mode of dissemination of public datasets will be via archive files accessible in the public domain. Public datasets will be de-identified so that data cannot be linked to individual research participants.
• IPD Sharing Time Frame: Datasets will be available at a minimum once the data have been accepted for peer-reviewed publication, and earlier if the data are deemed by the PI to be clean and the sharing of data is not expected to inhibit future opportunities for publication.
• IPD Sharing Access Criteria: A data sharing agreement must be completed and signed by the requesting investigator and the Principal Investigator before this transfer of data can be made.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No