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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shane Gilkey, Ohio University
ClinicalTrials.gov Identifier:
NCT00365690
First received: August 16, 2006
Last updated: May 6, 2013
Last verified: May 2013

August 16, 2006
May 6, 2013
February 2007
June 2012   (final data collection date for primary outcome measure)
Depression [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ]
  • Depression
  • Quality of Life
  • Life Stressor Burden
  • Psychological Symptoms (all measured at Months 3, 4, and 8)
Complete list of historical versions of study NCT00365690 on ClinicalTrials.gov Archive Site
Coping [ Time Frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up ] [ Designated as safety issue: No ]
  • Social Support
  • Coping (all measured at Months 3, 4, and 8)
Not Provided
Not Provided
 
Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV
Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults

This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Depression
  • 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.
  • 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.
  • 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.
  • Active Comparator: 1
    Participants will receive individual therapy upon request
    Intervention: Behavioral: Individual therapy
  • Active Comparator: 2
    Participants will receive telephone-administered supportive-expressive group therapy
    Intervention: Behavioral: Telephone-administered supportive-expressive therapy
  • Experimental: 3
    Participants will receive telephone-administered coping improvement group therapy
    Intervention: Behavioral: Telephone-administered coping improvement therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365690
R01 MH078749, R01MH078749, DAHBR ASNM
Yes
Shane Gilkey, Ohio University
Ohio University
National Institute of Mental Health (NIMH)
Study Chair: Rebecca Cale Ohio University IRB
Ohio University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP