Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 16, 2006 | ||||
| Last Updated Date | May 6, 2013 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Depression [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00365690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Coping [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV | ||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Heckman TG, Sikkema KJ, Hansen N, Kochman A, Heh V, Neufeld S; AIDS and Aging Research Group. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults. J Behav Med. 2011 Apr;34(2):102-11. Epub 2010 Sep 21. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 360 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00365690 | ||||
| Other Study ID Numbers ICMJE | R01 MH078749, R01MH078749, DAHBR ASNM | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Shane Gilkey, Ohio University | ||||
| Study Sponsor ICMJE | Ohio University | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Ohio University | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||