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

NCT ID: NCT00365690

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants will receive individual therapy upon request

Group Type ACTIVE_COMPARATOR

Individual therapy

Intervention Type BEHAVIORAL

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.

2

Participants will receive telephone-administered supportive-expressive group therapy

Group Type ACTIVE_COMPARATOR

Telephone-administered supportive-expressive therapy

Intervention Type BEHAVIORAL

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.

3

Participants will receive telephone-administered coping improvement group therapy

Group Type EXPERIMENTAL

Telephone-administered coping improvement therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Cale

Role: STUDY_CHAIR

Ohio University IRB

Locations

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Ohio University College of Osteopathic Medicine; Geriatric Medicine

Athens, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25090366 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23474642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20857188 (View on PubMed)

Other Identifiers

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R01MH078749

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR ASNM

Identifier Type: -

Identifier Source: secondary_id

R01MH078749

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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