Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers
NCT ID: NCT00183781
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2000-09-30
2004-06-30
Brief Summary
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Detailed Description
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Because of the multitude of stressors associated with HIV, HIV-infected individuals often rely on a network of family and friends for support; these caregivers, however, are often overwhelmed by their caregiver roles. They may experience helplessness, fear, and depression as a result of their added responsibilities. Family Intervention: Telephone Tracking (FITT) is a telephone-based intervention program that assists in identifying problems and resolving them through referrals to medical and community organizations that provide HIV-related support and services. It is also an educational resource that provides information on the many medical and psychological aspects of HIV infection. The main goal of FITT is to alleviate stress in both the HIV-infected individual and their support network by providing information and resources to help cope with HIV. The purpose of this study is to evaluate the effectiveness of FITT in improving family functioning, enhancing coping skills, and reducing depression in HIV-infected individuals and their caregivers.
This 12-month study will enroll recently diagnosed HIV-infected individuals and one family member or friend who is identified as their primary caregiver. Each pair will be randomly assigned to either the FITT intervention group or to an assessment-only group that will not receive FITT. Individuals who are assigned to receive FITT will utilize the service for Months 1 through 6. HIV-infected participants in both groups will also receive regular medical care throughout the study. Outcome measurements will include self-assessments of depression, coping, and family functioning. In addition, participants receiving FITT will be asked to evaluate the effectiveness of the telephone intervention. All measurements will be assessed at baseline, and Months 3, 6, and 12.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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FITT: Family Intervention - Telephone Tracking
Eligibility Criteria
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Inclusion Criteria
* Currently undergoing HIV care in one of the BRUNAP clinics
* Ability to co-enroll with a primary HIV informal caregiver
* English- or Spanish-speaking
Exclusion Criteria
* Lacks regular access to a telephone to receive calls
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Butler Hospital
OTHER
Responsible Party
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RI Hospital
Principal Investigators
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Michael Stein, MD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Penelope Dennehy, MD
Role: STUDY_DIRECTOR
Rhode Island Hospital
Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Pirraglia PA, Bishop D, Herman DS, Trisvan E, Lopez RA, Torgersen CS, Van Hof AM, Anderson BJ, Miller I, Stein MD. Caregiver burden and depression among informal caregivers of HIV-infected individuals. J Gen Intern Med. 2005 Jun;20(6):510-4. doi: 10.1111/j.1525-1497.2005.0073.x.
Stein M, Herman DS, Trisvan E, Pirraglia P, Engler P, Anderson BJ. Alcohol use and sexual risk behavior among human immunodeficiency virus-positive persons. Alcohol Clin Exp Res. 2005 May;29(5):837-43. doi: 10.1097/01.alc.0000164363.40533.e0.
Other Identifiers
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