CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

Not Applicable

Completed

• Conditions: Stress Disorder; HIV; Human Immunodeficiency Virus; Fatigue
• Interventions: Behavioral: CBSM-SMI; Behavioral: CBSM-SMI control

• Registration Number: NCT03149094
• Lead Sponsor: Medical University of South Carolina

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-04-27
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Primary Completion: 2018-03-20
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• HIV positive
• Reads and understands English
• Scores greater than 5 on the HIV-Related Fatigue Scale
• Mentally competent to give informed consent

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBSM-SMI	CBSM-SMI	The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
CBSM-SMI control	CBSM-SMI control	The control group will receive an app called LifeSum, which focuses on healthy lifestyles.

Primary Outcome Measures

Name	Time	Method
Feasibility and Acceptability Scale	22 weeks	The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI-II)	22 weeks	The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
CD4 count from the medical record	22 weeks	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.
PROMIS Short Form - Fatigue 8a	22 weeks	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.
Life Experiences Scale	22 weeks	The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
HIV viral load information from the medical record	22 weeks	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)	22 weeks	The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
The State Trait Anxiety Inventory (STAI)-State	22 weeks	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States