Mobile Stress Management Program for African American Women

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863781
• Other study ID #: MD014077
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2023
• Source: ISA Associates, Inc.
• Contact: Douglas Billings, PhD
• Phone: 7037390880
• Email: dbillings[@]isagroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	ISA Associates	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ISA Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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