Clinical trial NCT03149094: CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue
Official title: Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Stress Disorder
Human Immunodeficiency Virus
Fatigue
Keywords: Self-Management
mHealth
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and Acceptability Scale
timeFrame: Baseline
measure: Feasibility and Acceptability Scale
timeFrame: 10 weeks
measure: Feasibility and Acceptability Scale
timeFrame: 22 weeks
Secondary outcomes:
measure: HIV-Related Fatigue Scale (HRFS)
timeFrame: Baseline
measure: HIV-Related Fatigue Scale (HRFS)
timeFrame: 5 weeks
measure: HIV-Related Fatigue Scale (HRFS)
timeFrame: 10 weeks
measure: HIV-Related Fatigue Scale (HRFS)
timeFrame: 22 weeks
measure: PROMIS Short Form - Fatigue 8a
timeFrame: Baseline
measure: PROMIS Short Form - Fatigue 8a
timeFrame: 5 weeks
measure: PROMIS Short Form - Fatigue 8a
timeFrame: 10 weeks
measure: PROMIS Short Form - Fatigue 8a
timeFrame: 22 weeks
measure: The State Trait Anxiety Inventory (STAI)-State
timeFrame: Baseline
measure: The State Trait Anxiety Inventory (STAI)-State
timeFrame: 5 weeks
measure: The State Trait Anxiety Inventory (STAI)-State
timeFrame: 10 weeks
measure: The State Trait Anxiety Inventory (STAI)-State
timeFrame: 22 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 5 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: 10 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: 22 weeks
measure: Life Experiences Scale
timeFrame: Baseline
measure: Life Experiences Scale
timeFrame: 5 weeks
measure: Life Experiences Scale
timeFrame: 10 weeks
measure: Life Experiences Scale
timeFrame: 22 weeks
measure: CD4 count from the medical record
timeFrame: Baseline
measure: CD4 count from the medical record
timeFrame: 22 weeks
measure: HIV viral load information from the medical record
timeFrame: Baseline
measure: HIV viral load information from the medical record
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.