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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
this group will receive the LifeSum app.
Medical University of South Carolina
Charleston, South Carolina, United States
Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time frame: Baseline
Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time frame: 10 weeks
Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time frame: 22 weeks
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time frame: Baseline
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time frame: 5 weeks
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time frame: 10 weeks
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 22 weeks
PROMIS Short Form - Fatigue 8a
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.
Time frame: Baseline
PROMIS Short Form - Fatigue 8a
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.
Time frame: 5 weeks
PROMIS Short Form - Fatigue 8a
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.
Time frame: 10 weeks
PROMIS Short Form - Fatigue 8a
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.
Time frame: 22 weeks
The State Trait Anxiety Inventory (STAI)-State
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.
Time frame: Baseline
The State Trait Anxiety Inventory (STAI)-State
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.
Time frame: 5 weeks
The State Trait Anxiety Inventory (STAI)-State
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.
Time frame: 10 weeks
The State Trait Anxiety Inventory (STAI)-State
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.
Time frame: 22 weeks
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time frame: Baseline
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time frame: 5 weeks
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time frame: 10 weeks
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time frame: 22 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time frame: Baseline
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time frame: 5 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time frame: 10 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time frame: 22 weeks
CD4 count from the medical record
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.
Time frame: Baseline
CD4 count from the medical record
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.
Time frame: 22 weeks
HIV viral load information from the medical record
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.
Time frame: Baseline
HIV viral load information from the medical record
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.
Time frame: 22 weeks