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Completed

NCT Number: NCT03149094

CBSM Intervention Via mHealth 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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Fatigue Genital Diseases HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Stress Disorder Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBSM-SMI

Behavioral

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

CBSM-SMI control

Behavioral

this group will receive the LifeSum app.

Primary outcomes

  1. Feasibility and Acceptability Scale

    Time frame: Baseline

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

  2. Feasibility and Acceptability Scale

    Time frame: 10 weeks

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

  3. Feasibility and Acceptability Scale

    Time frame: 22 weeks

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

Secondary outcomes

  1. HIV-Related Fatigue Scale (HRFS)

    Time frame: Baseline

    The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.

  2. HIV-Related Fatigue Scale (HRFS)

    Time frame: 5 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.

  3. HIV-Related Fatigue Scale (HRFS)

    Time frame: 10 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.

  4. HIV-Related Fatigue Scale (HRFS)

    Time frame: 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.

  5. PROMIS Short Form - Fatigue 8a

    Time frame: Baseline

    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.

  6. PROMIS Short Form - Fatigue 8a

    Time frame: 5 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.

  7. PROMIS Short Form - Fatigue 8a

    Time frame: 10 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.

  8. PROMIS Short Form - Fatigue 8a

    Time frame: 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.

  9. The State Trait Anxiety Inventory (STAI)-State

    Time frame: Baseline

    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. The State Trait Anxiety Inventory (STAI)-State

    Time frame: 5 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.

  11. The State Trait Anxiety Inventory (STAI)-State

    Time frame: 10 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.

  12. The State Trait Anxiety Inventory (STAI)-State

    Time frame: 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.

  13. Beck Depression Inventory (BDI-II)

    Time frame: Baseline

    The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  14. Beck Depression Inventory (BDI-II)

    Time frame: 5 weeks

    The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  15. Beck Depression Inventory (BDI-II)

    Time frame: 10 weeks

    The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  16. Beck Depression Inventory (BDI-II)

    Time frame: 22 weeks

    The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  17. Life Experiences Scale

    Time frame: Baseline

    The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.

  18. Life Experiences Scale

    Time frame: 5 weeks

    The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.

  19. Life Experiences Scale

    Time frame: 10 weeks

    The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.

  20. Life Experiences Scale

    Time frame: 22 weeks

    The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.

  21. CD4 count from the medical record

    Time frame: Baseline

    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. CD4 count from the medical record

    Time frame: 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.

  23. HIV viral load information from the medical record

    Time frame: Baseline

    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.

  24. HIV viral load information from the medical record

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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