Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00365690 |
| Other study ID # |
R01MH078749 |
| Secondary ID |
R01MH078749DAHBR |
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 2007 |
| Est. completion date |
June 2012 |
Study information
| Verified date |
May 2013 |
| Source |
Ohio University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
