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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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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.

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.

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 ]
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 ]
Condition  HIV Infections
Depression
Intervention  Behavioral: Telephone-administered coping improvement therapy
Behavioral: Telephone-administered supportive-expressive therapy
Behavioral: Individual therapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  360
Start Date  February 2007
Completion Date June 2010
Eligibility 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
Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Timothy G. Heckman, PhD     740-597-1744     heckmant@ohiou.edu    
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 
Study Chair:     Rebecca Cale     Ohio University IRB    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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