CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; HIV; Stress Disorder; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: CBSM-SMI; Behavioral: CBSM-SMI control

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CBSM-SMI; The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.	Behavioral: CBSM-SMI; The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
ACTIVE_COMPARATOR: CBSM-SMI control; The control group will receive an app called LifeSum, which focuses on healthy lifestyles.	Behavioral: CBSM-SMI control; this group will receive the LifeSum app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline
Life Experiences Scale	The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.	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.	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.	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.	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.	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.	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.	22 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of Nursing Research (NINR)

Publications and helpful links

General Publications

• Barroso J, Madisetti M, Mueller M. A Feasibility Study to Develop and Test a Cognitive Behavioral Stress Management Mobile Health Application for HIV-Related Fatigue. J Pain Symptom Manage. 2020 Feb;59(2):242-253. doi: 10.1016/j.jpainsymman.2019.09.009. Epub 2019 Sep 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2017
• Primary Completion (ACTUAL): March 20, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: mHealth; Self-Management
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Fatigue; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: Pro00057504; 1P20NR016575-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No