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Mobile Stress Management Program for African American Women

Primary Purpose

Psychological Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile cognitive-behavioral stress management intervention
Control
Sponsored by
ISA Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

-

Sites / Locations

  • ISA AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 22, 2021
Last Updated
April 19, 2023
Sponsor
ISA Associates, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04863781
Brief Title
Mobile Stress Management Program for African American Women
Official Title
Reducing Health Disparities Among African American Women: A Mobile Cognitive Behavioral Stress Management Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISA Associates, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile cognitive-behavioral stress management intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Baseline Stress on the 10-point Perceived Stress Scale at Week 24
Description
10-item survey that measures the degree to which an individual perceives his/her life as uncontrollable, unpredictable, and overwhelming
Time Frame
Baseline and Week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Billings, PhD
Phone
7037390880
Ext
3
Email
dbillings@isagroup.com
Facility Information:
Facility Name
ISA Associates
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Morcos, MPH
Phone
703-264-7223
Email
mmorcos@isagroup.com
First Name & Middle Initial & Last Name & Degree
Douglas Billings, PhD
Phone
7037390880
Ext
3
Email
dbillings@isagroup.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Mobile Stress Management Program for African American Women

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