CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149094
• Other study ID #: Pro00057504
• Secondary ID: 1P20NR016575-01
• Status: Completed
• Phase: N/A
• Start date: April 27, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Fatigue
• HIV
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Stress Disorder

Intervention

Behavioral:
• 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
this group will receive the LifeSum app.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Life Experiences Scale	The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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