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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV | ||||
| Official Title † | Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults | ||||
| Brief Summary | This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Depression [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] Quality of Life [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] Life Stressor Burden [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] Psychological Symptoms [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Social Support [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] Coping [ Time Frame: Measured at Months 3, 4, and 8 ] [ Designated as safety issue: No ] |
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| Condition † | HIV Infections Depression |
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| Intervention † | Behavioral: Telephone-administered coping improvement therapy Behavioral: Telephone-administered supportive-expressive therapy Behavioral: Individual therapy |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 360 | ||||
| Start Date † | February 2007 | ||||
| Completion Date | June 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00365690 | ||||
| Organization ID | R01 MH78749 | ||||
| Secondary IDs †† | DAHBR ASNM | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | August 16, 2006 | ||||
| Last Updated Date | March 27, 2008 | ||||