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

Ohio University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression; HIV Infections

Treatments: Behavioral: Telephone-administered coping improvement therapy; Behavioral: Individual therapy; Behavioral: Telephone-administered supportive-expressive therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00365690

R01MH078749 (U.S. NIH Grant/Contract)

DAHBR ASNM

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

1

Active Comparator group

Description:

Participants will receive individual therapy upon request

Treatment:

Behavioral: Individual therapy

2

Active Comparator group

Description:

Participants will receive telephone-administered supportive-expressive group therapy

Treatment:

Behavioral: Telephone-administered supportive-expressive therapy

3

Experimental group

Description:

Participants will receive telephone-administered coping improvement group therapy

Treatment:

Behavioral: Telephone-administered coping improvement therapy