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Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shane Gilkey, Ohio University
ClinicalTrials.gov Identifier:
NCT00365690
First received: August 16, 2006
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV.


Condition Intervention Phase
HIV Infections
Depression
Behavioral: Telephone-administered coping improvement therapy
Behavioral: Telephone-administered supportive-expressive therapy
Behavioral: Individual therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults

Resource links provided by NLM:


Further study details as provided by Ohio University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coping [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive individual therapy upon request
Behavioral: Individual therapy
Participants will receive no active treatment, but will have access to community-based support services that are commonly available to people living with HIV/AIDS. Additionally, participants who experience pronounced periods of emotional crisis and request assistance will be provided with brief, individual, telephone-based therapy by study clinicians.
Active Comparator: 2
Participants will receive telephone-administered supportive-expressive group therapy
Behavioral: Telephone-administered supportive-expressive therapy
Telephone-administered supportive-expressive therapy is aimed to improve relationships with friends, family members, and health care providers. Participants in will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. The first 60 minutes of each session will focus on discussing topics believed to be of interest to older adults with HIV and providing up-to-date information related to living with HIV/AIDS. The last 30 minutes of each session will be devoted to discussing topics raised by the group.
Experimental: 3
Participants will receive telephone-administered coping improvement group therapy
Behavioral: Telephone-administered coping improvement therapy
Telephone-administered coping improvement therapy is aimed to improve coping in older adults living with HIV/AIDS. Participants will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. Cognitive behavioral principles will be used to evaluate stressor severity, develop problem- and emotion-focused coping skills, determine the relationship between coping strategies and stressor controllability, and optimize coping through use of social support resources. Between weekly sessions, participants will also work to improve coping abilities on their own.

Detailed Description:

According to a 2004 report by the Centers for Disease Control and Prevention (CDC), by December, 2003, more than 57,000 people in the United States were 55 years of age or older when they were diagnosed with AIDS. Furthermore, the CDC predicts that, by 2015, 50% of all cases of HIV/AIDS in the U.S. will occur in people 50 years of age or over. HIV infected older adults tend to experience elevated levels of depression and suicidal ideation, confront complex barriers to medical and mental health services, and lack social support resources. Unfortunately, very few interventions are available to improve quality of life in older adults living with HIV/AIDS. Moreover, many older adults with HIV/AIDS do not receive adequate treatment because of geographic isolation, physical limitations, or confidentiality concerns. A therapy program administered via the telephone may be a more accessible option for this population. This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV.

Participants in this 11-month, single-blind study will first complete self-administered surveys in the privacy of their own homes. Participants will then be randomly assigned to one of the following three study groups: (1) individual therapy upon request; (2) telephone-administered supportive-expressive group therapy; or (3) telephone-administered coping improvement group therapy. Participants in Group 1 will receive no active treatment, but will have access to community-based support services that are commonly available to people living with HIV/AIDS. Additionally, participants in Group 1 who experience pronounced periods of emotional crisis and request assistance will be provided with brief, individual, telephone-based therapy by study clinicians. Participants in Groups 2 and 3 will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. For Group 2, the first 60 minutes of each session will focus on discussing topics believed to be of interest to older adults with HIV and providing up-to-date information related to living with HIV/AIDS. The last 30 minutes of each session will be devoted to discussing topics raised by the group. For Group 3, cognitive-behavioral principles will be used to evaluate stressor severity, develop problem- and emotion-focused coping skills, determine the relationship between coping strategies and stressor controllability, and optimize coping through use of social support resources. Between weekly sessions, participants will also work to improve coping abilities on their own. All participants will complete follow-up assessments via telephone over the 8 months following completion of the interventions.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently living with HIV or AIDS
  • Score of 75 or higher on the Mini-Mental Status Examination

Exclusion Criteria:

  • Active use of drugs and/or alcohol
  • Poor cognitive functioning
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365690

Locations
United States, Ohio
Ohio University College of Osteopathic Medicine; Geriatric Medicine
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Investigators
Study Chair: Rebecca Cale Ohio University IRB
  More Information

No publications provided by Ohio University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shane Gilkey, Assistant Vice President for Research, Ohio University
ClinicalTrials.gov Identifier: NCT00365690     History of Changes
Other Study ID Numbers: R01 MH078749, R01MH078749, DAHBR ASNM
Study First Received: August 16, 2006
Last Updated: May 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Ohio University:
AIDS
Older Adults
Telephone
Telemedicine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Depression
HIV Infections
Behavioral Symptoms
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014