NCT00365690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 22, 2022

Status Verified

May 1, 2013

Enrollment Period

5.3 years

First QC Date

August 16, 2006

Last Update Submit

September 19, 2022

Conditions

Keywords

AIDSOlder AdultsTelephoneTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up

Secondary Outcomes (1)

  • Coping

    Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up

Study Arms (3)

1

ACTIVE COMPARATOR

Participants will receive individual therapy upon request

Behavioral: Individual therapy

2

ACTIVE COMPARATOR

Participants will receive telephone-administered supportive-expressive group therapy

Behavioral: Telephone-administered supportive-expressive therapy

3

EXPERIMENTAL

Participants will receive telephone-administered coping improvement group therapy

Behavioral: Telephone-administered coping improvement therapy

Interventions

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.

3

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.

2

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.

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently living with HIV or AIDS
  • Score of 75 or higher on the Mini-Mental Status Examination

You may not qualify if:

  • Active use of drugs and/or alcohol
  • Poor cognitive functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University College of Osteopathic Medicine; Geriatric Medicine

Athens, Ohio, 45701, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

HIV InfectionsDepressionAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehaviorSlow Virus Diseases

Study Officials

  • Rebecca Cale

    Ohio University IRB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

February 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 22, 2022

Record last verified: 2013-05

Locations