search
Back to results

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

Primary Purpose

HIV Infections, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telephone-administered coping improvement therapy
Telephone-administered supportive-expressive therapy
Individual therapy
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS, Older Adults, Telephone, Telemedicine

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio University College of Osteopathic Medicine; Geriatric Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Participants will receive individual therapy upon request

Participants will receive telephone-administered supportive-expressive group therapy

Participants will receive telephone-administered coping improvement group therapy

Outcomes

Primary Outcome Measures

Depression

Secondary Outcome Measures

Coping

Full Information

First Posted
August 16, 2006
Last Updated
September 19, 2022
Sponsor
Ohio University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00365690
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Depression
Keywords
AIDS, Older Adults, Telephone, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive individual therapy upon request
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive telephone-administered supportive-expressive group therapy
Arm Title
3
Arm Type
Experimental
Arm Description
Participants will receive telephone-administered coping improvement group therapy
Intervention Type
Behavioral
Intervention Name(s)
Telephone-administered coping improvement therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-administered supportive-expressive therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression
Time Frame
Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up
Secondary Outcome Measure Information:
Title
Coping
Time Frame
Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Cale
Organizational Affiliation
Ohio University IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Ohio University College of Osteopathic Medicine; Geriatric Medicine
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25090366
Citation
Heckman BD, Lovejoy TI, Heckman TG, Anderson T, Grimes T, Sutton M, Bianco JA. The moderating role of sexual identity in group teletherapy for adults aging with HIV. Behav Med. 2014;40(3):134-42. doi: 10.1080/08964289.2014.925417.
Results Reference
derived
PubMed Identifier
23474642
Citation
Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Mohr D, Sutton M, Bianco JA, Gau JT. Supportive-expressive and coping group teletherapies for HIV-infected older adults: a randomized clinical trial. AIDS Behav. 2013 Nov;17(9):3034-44. doi: 10.1007/s10461-013-0441-0.
Results Reference
derived
PubMed Identifier
20857188
Citation
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. doi: 10.1007/s10865-010-9292-6. Epub 2010 Sep 21.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs