Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Medical University of South Carolina
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility and Acceptability Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.
Detailed Description
For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV positive
- •Reads and understands English
- •Scores greater than 5 on the HIV-Related Fatigue Scale
- •Mentally competent to give informed consent
Exclusion Criteria
- •Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis)
- •Pregnant women and women who are less than 1 year postpartum
- •Active psychosis or dementia
- •Suicidal ideation with clear intent
- •Current substance dependence
Outcomes
Primary Outcomes
Feasibility and Acceptability Scale
Time Frame: 22 weeks
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Secondary Outcomes
- Beck Depression Inventory (BDI-II)(22 weeks)
- CD4 count from the medical record(22 weeks)
- PROMIS Short Form - Fatigue 8a(22 weeks)
- Life Experiences Scale(22 weeks)
- HIV viral load information from the medical record(22 weeks)
- HIV-Related Fatigue Scale (HRFS)(22 weeks)
- The State Trait Anxiety Inventory (STAI)-State(22 weeks)