Clinical trial NCT00183781: Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers
Official title: Adapting to HIV Disease - A Family Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Telephone intervention
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Decreased depression; measured at baseline, and Months 3, 6, and 12
measure: Improved coping; measured at baseline, and Months 3, 6, and 12
measure: Improved family functioning; measured at baseline, and Months 3, 6, and 12
Secondary outcomes:
measure: Efficacy of FITT intervention; measured at baseline, and Months 3, 6, and 12
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Penelope Dennehy, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.