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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00365690 |
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 |
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HIV Infections Depression |
Behavioral: Telephone-administered coping improvement therapy Behavioral: Telephone-administered supportive-expressive therapy Behavioral: Individual therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults |
Estimated Enrollment: | 360 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive individual therapy upon request
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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.
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2: Active Comparator
Participants will receive telephone-administered supportive-expressive group therapy
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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.
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3: Experimental
Participants will receive telephone-administered coping improvement group therapy
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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.
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy G. Heckman, PhD | 740-597-1744 | heckmant@ohiou.edu |
United States, Ohio | |
Ohio University College of Osteopathic Medicine; Geriatric Medicine | Recruiting |
Athens, Ohio, United States, 45701 | |
Contact: Shane L Gilkey 740-593-9813 gilkeys@ohiou.edu |
Study Chair: | Rebecca Cale | Ohio University IRB |
Responsible Party: | Ohio University ( Timothy G. Heckman ) |
Study ID Numbers: | R01 MH78749, DAHBR ASNM |
Study First Received: | August 16, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00365690 |
Health Authority: | United States: Federal Government |
AIDS Older Adults Telephone Telemedicine |
Virus Diseases Sexually Transmitted Diseases, Viral Depression HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Quality of Life Depressive Disorder Retroviridae Infections Immunologic Deficiency Syndromes Behavioral Symptoms |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |