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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04863781




Registration number
NCT04863781
Ethics application status
Date submitted
22/04/2021
Date registered
28/04/2021

Titles & IDs
Public title
Mobile Stress Management Program for African American Women
Scientific title
Reducing Health Disparities Among African American Women: a Mobile Cognitive Behavioral Stress Management Intervention
Secondary ID [1] 0 0
MD014077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Stress 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mobile cognitive-behavioral stress management intervention
BEHAVIORAL - Control

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

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: 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.

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Baseline Stress on the 10-point Perceived Stress Scale at Week 24
Timepoint [1] 0 0
Baseline and Week 24

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2024
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Other
Name
ISA Associates, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04863781