Fatigue, HIV, Human Immunodeficiency Virus, Stress Disorder
Conditions
Keywords
Self-Management, mHealth
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.
Interventions
BEHAVIORALCBSM-SMI
The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
BEHAVIORALCBSM-SMI control
this group will receive the LifeSum app.
Sponsors
National Institute of Nursing Research (NINR)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability Scale | Baseline | The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Short Form - Fatigue 8a | Baseline | The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role. |
| The State Trait Anxiety Inventory (STAI)-State | Baseline | The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale. |
| HIV viral load information from the medical record | Baseline | A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus. |
| HIV-Related Fatigue Scale (HRFS) | Baseline | The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection. |
| Life Experiences Scale | Baseline | The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events. |
| CD4 count from the medical record | Baseline | A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression. |
| Beck Depression Inventory (BDI-II) | Baseline | The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression. |
Countries
United States
Outcome results
None listed