CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Human Immunodeficiency Virus; Stress Disorder; HIV; Fatigue

Treatments: Behavioral: CBSM-SMI; Behavioral: CBSM-SMI control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03149094

1P20NR016575-01 (U.S. NIH Grant/Contract)

Pro00057504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CBSM-SMI

Experimental group

Description:

The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.

Treatment:

Behavioral: CBSM-SMI

CBSM-SMI control

Active Comparator group

Description:

The control group will receive an app called LifeSum, which focuses on healthy lifestyles.

Treatment:

Behavioral: CBSM-SMI control