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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00183781
First received: September 14, 2005
Last updated: August 20, 2013
Last verified: August 2013

September 14, 2005
August 20, 2013
September 2000
Not Provided
  • Decreased depression; measured at baseline, and Months 3, 6, and 12
  • Improved coping; measured at baseline, and Months 3, 6, and 12
  • Improved family functioning; measured at baseline, and Months 3, 6, and 12
  • Decreased depression; measured at Month 12
  • Improved coping; measured at Month 12
  • Improved family functioning; measured at Month 12
Complete list of historical versions of study NCT00183781 on ClinicalTrials.gov Archive Site
Efficacy of FITT intervention; measured at baseline, and Months 3, 6, and 12
Efficacy of FITT intervention; measured at Month 12
Not Provided
Not Provided
 
Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers
Adapting to HIV Disease - A Family Intervention

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Behavioral: FITT: Family Intervention - Telephone Tracking
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2004
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183781
R01 MH63051, R01MH063051, DAHBR AZ-A
Not Provided
Michael Stein, M.D./Principal Investigator, RI Hospital
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
Butler Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP