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Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers

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ClinicalTrials.gov Identifier: NCT00183781
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 22, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking (FITT) program in improving depression, coping, and family functioning in HIV-infected individuals and their caregivers.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: FITT: Family Intervention - Telephone Tracking Phase 3

Detailed Description:

Individuals who are newly diagnosed with HIV often experience a variety of social and psychological problems, which can leave them depressed and unable to cope with their disease. The complex financial, legal, and psychiatric issues that many HIV-infected individuals must face can be stressful and can negatively affect their health; they may miss doctors' appointments or fail to adhere to a strict HIV medication regimen. The combination of stress and inconsistent medical care can affect the immune system and potentially worsen HIV symptoms.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapting to HIV Disease - A Family Intervention
Study Start Date : September 2000
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Decreased depression; measured at baseline, and Months 3, 6, and 12
  2. Improved coping; measured at baseline, and Months 3, 6, and 12
  3. Improved family functioning; measured at baseline, and Months 3, 6, and 12

Secondary Outcome Measures :
  1. Efficacy of FITT intervention; measured at baseline, and Months 3, 6, and 12

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently began HIV care
  • 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:

  • Schizophrenia
  • Lacks regular access to a telephone to receive calls
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183781


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
More Information

Publications:
Responsible Party: Michael Stein, M.D./Principal Investigator, RI Hospital
ClinicalTrials.gov Identifier: NCT00183781     History of Changes
Other Study ID Numbers: R01MH063051 ( U.S. NIH Grant/Contract )
DAHBR AZ-A
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Butler Hospital:
HIV
Telephone intervention

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases