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Behavioral Intervention
Mobile Stress Management Program for Stress
N/A
Recruiting
Research Sponsored by ISA Associates, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights
Study Summary
This trial aims to reduce stress experienced by African American women by developing a mobile cognitive-behavioral stress management intervention (m-CBSMi). It will be used to teach adaptive coping skills to help manage stress.
Who is the study for?
This trial is for African American women who feel stressed, particularly due to racial or gender discrimination. They must identify as Black, own a smartphone, and have experienced discrimination at least a few times in the past year. Participants should also be moderately stressed with a score of 6+ on the Perceived Stress Scale and have basic English literacy.Check my eligibility
What is being tested?
The study tests a mobile cognitive-behavioral stress management program (m-CBSMi) designed specifically for African American women. It delivers supportive and educational content via text messages and mobile web videos to teach stress management techniques.See study design
What are the potential side effects?
Since this intervention involves non-medical treatments like education and motivational texts, there are no direct physical side effects expected from participating in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Baseline Stress on the 10-point Perceived Stress Scale at Week 24
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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
Group II: ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
ISA Associates, Inc.Lead Sponsor
4 Previous Clinical Trials
661 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced discrimination and can share this information with the study staff.You have a smartphone.You need to score 6 or higher on a stress questionnaire called the Perceived Stress Scale (PSS).You should not be experiencing too much stress.You identify yourself as Black.I have faced discrimination based on my race or gender several times in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spots available to participate in this research study?
"According to information found on clinicialtrials.gov, the trial's recruitment has been concluded as of February 28th 2023. Nonetheless, there are still 95 other clinical trials actively looking for participants at this time."
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