HIVNCT03149094
CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue
A study testing CBSM-SMI in people with HIV and Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Stress Disorder, Human Immunodeficiency Virus
- What is being tested?
- CBSM-SMI
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- Reads and understands English
- Scores greater than 5 on the HIV-Related Fatigue Scale
- Mentally competent to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention 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.
Read the 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.
- Conditions
- HIV, Stress Disorder, Human Immunodeficiency Virus, Fatigue
- Being tested
- CBSM-SMI, CBSM-SMI control
- Keywords
- Self-Management, mHealth
- Medical subject headings
- Stress Disorders, Traumatic, Acquired Immunodeficiency Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBSM-SMIBehavioural
The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
CBSM-SMI controlBehavioural
this group will receive the LifeSum app.
| Study group | Role | What they receive |
|---|---|---|
| CBSM-SMI | Experimental | The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets. Receives: Behavioral: CBSM-SMI |
| CBSM-SMI control | Active comparator | The control group will receive an app called LifeSum, which focuses on healthy lifestyles. Receives: Behavioral: CBSM-SMI control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 10 weeks
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.
Measured: 22 weeks
Secondary outcomes (24)
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.
Measured: Baseline
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.
Measured: 5 weeks
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.
Measured: 10 weeks
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.
Measured: 22 weeks
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.
Measured: Baseline
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.
Measured: 5 weeks
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.
Measured: 10 weeks
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.
Measured: 22 weeks
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.
Measured: Baseline
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.
Measured: 5 weeks
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.
Measured: 10 weeks
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.
Measured: 22 weeks
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.
Measured: Baseline
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.
Measured: 5 weeks
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.
Measured: 10 weeks
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.
Measured: 22 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Measured: Baseline
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Measured: 5 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Measured: 10 weeks
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Measured: 22 weeks
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.
Measured: Baseline
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.
Measured: 22 weeks
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.
Measured: Baseline
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.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start27 Apr 2017
- Primary completion20 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149094
- Sponsor's protocol ID
- Pro00057504
- Other IDs
- 1P20NR016575-01
- Status last verified
- Jul 2018
- First submitted
- 4 May 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31539601
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
- ClinicalTrials.gov ID
- NCT03149094
- Acronym / sponsor ID
- Pro00057504
- Conditions
- HIV, Stress Disorder, Human Immunodeficiency Virus, Fatigue
- Keywords
- Self-Management, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBSM-SMI | Experimental | Behavioral: CBSM-SMIThe intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets. |
| CBSM-SMI control | Active comparator | Behavioral: CBSM-SMI controlThe control group will receive an app called LifeSum, which focuses on healthy lifestyles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive
- Reads and understands English
- Scores greater than 5 on the HIV-Related Fatigue Scale
- Mentally competent to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBSM-SMIThe intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets. | Behavioural | CBSM-SMI |
| CBSM-SMI controlthis group will receive the LifeSum app. | Behavioural | CBSM-SMI control |
Primary outcome
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.
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.
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.
24 secondary outcomes
HIV-Related Fatigue Scale (HRFS)
Time frame: Baseline
HIV-Related Fatigue Scale (HRFS)
Time frame: 5 weeks
HIV-Related Fatigue Scale (HRFS)
Time frame: 10 weeks
HIV-Related Fatigue Scale (HRFS)
Time frame: 22 weeks
PROMIS Short Form - Fatigue 8a
Time frame: Baseline
PROMIS Short Form - Fatigue 8a
Time frame: 5 weeks
PROMIS Short Form - Fatigue 8a
Time frame: 10 weeks
PROMIS Short Form - Fatigue 8a
Time frame: 22 weeks
The State Trait Anxiety Inventory (STAI)-State
Time frame: Baseline
The State Trait Anxiety Inventory (STAI)-State
Time frame: 5 weeks
The State Trait Anxiety Inventory (STAI)-State
Time frame: 10 weeks
The State Trait Anxiety Inventory (STAI)-State
Time frame: 22 weeks
Beck Depression Inventory (BDI-II)
Time frame: Baseline
Beck Depression Inventory (BDI-II)
Time frame: 5 weeks
Beck Depression Inventory (BDI-II)
Time frame: 10 weeks
Beck Depression Inventory (BDI-II)
Time frame: 22 weeks
Life Experiences Scale
Time frame: Baseline
Life Experiences Scale
Time frame: 5 weeks
Life Experiences Scale
Time frame: 10 weeks
Life Experiences Scale
Time frame: 22 weeks
CD4 count from the medical record
Time frame: Baseline
CD4 count from the medical record
Time frame: 22 weeks
HIV viral load information from the medical record
Time frame: Baseline
HIV viral load information from the medical record
Time frame: 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 31539601Barroso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBSM-SMI in people with HIV and Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.