NCT03149094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

May 4, 2017

Last Update Submit

July 17, 2018

Conditions

HIVStress DisorderHuman Immunodeficiency VirusFatigue

Keywords

Self-ManagementmHealth

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (24)

  • HIV-Related Fatigue Scale (HRFS)

    Baseline

  • HIV-Related Fatigue Scale (HRFS)

    5 weeks

  • HIV-Related Fatigue Scale (HRFS)

    10 weeks

  • HIV-Related Fatigue Scale (HRFS)

    22 weeks

  • PROMIS Short Form - Fatigue 8a

    Baseline

  • +19 more secondary outcomes

Study Arms (2)

CBSM-SMI

EXPERIMENTAL

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

Behavioral: CBSM-SMI

CBSM-SMI control

ACTIVE COMPARATOR

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

Behavioral: CBSM-SMI control

Interventions

CBSM-SMIBEHAVIORAL

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

CBSM-SMI
CBSM-SMI controlBEHAVIORAL

this group will receive the LifeSum app.

CBSM-SMI control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • Reads and understands English
  • Scores greater than 5 on the HIV-Related Fatigue Scale
  • Mentally competent to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 31539601DERIVED

MeSH Terms

Conditions

Stress Disorders, TraumaticAcquired Immunodeficiency SyndromeFatigue

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 11, 2017

Study Start

April 27, 2017

Primary Completion

March 20, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)