HIV InfectionsPhase 2/3NCT00365690
Effectiveness of a Telephone-Delivered Behavioral Treatment to Improve the Quality of Life of Older Adults With HIV
A Phase 2/3 study testing Telephone-administered coping improvement therapy, Telephone-administered supportive-expressive therapy and Individual therapy in people with HIV Infections and Depression, run by Ohio University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infections, Depression
- What is being tested?
- Telephone-administered coping improvement therapy, Telephone-administered supportive-expressive therapy and Individual therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently living with HIV or AIDS
- Score of 75 or higher on the Mini-Mental Status Examination
Who cannot join
- Active use of drugs and/or alcohol
- Poor cognitive functioning
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University College of Osteopathic Medicine; Geriatric Medicine
Athens, Ohio, 45701
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, Depression
- Being tested
- Telephone-administered coping improvement therapy, Telephone-administered supportive-expressive therapy, Individual therapy
- Keywords
- AIDS, Older Adults, Telephone, Telemedicine
- Medical subject headings
- HIV Infections, Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-administered coping improvement therapyBehavioural
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.
Telephone-administered supportive-expressive therapyBehavioural
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.
Individual therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive individual therapy upon request Receives: Behavioral: Individual therapy |
| 2 | Active comparator | Participants will receive telephone-administered supportive-expressive group therapy Receives: Behavioral: Telephone-administered supportive-expressive therapy |
| 3 | Experimental | Participants will receive telephone-administered coping improvement group therapy Receives: Behavioral: Telephone-administered coping improvement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up
Secondary outcomes (1)
Coping
Measured: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startFeb 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rebecca Cale, Study chair, Ohio University IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365690
- Sponsor's protocol ID
- R01MH078749
- Other IDs
- R01MH078749, DAHBR ASNM
- Status last verified
- May 2013
- First submitted
- 16 Aug 2006
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25090366Heckman 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.
PubMed 23474642Heckman 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.
PubMed 20857188
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults
- ClinicalTrials.gov ID
- NCT00365690
- Acronym / sponsor ID
- R01MH078749
- Conditions
- HIV Infections, Depression
- Keywords
- AIDS, Older Adults, Telephone, Telemedicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Individual therapyParticipants will receive individual therapy upon request |
| 2 | Active comparator | Behavioral: Telephone-administered supportive-expressive therapyParticipants will receive telephone-administered supportive-expressive group therapy |
| 3 | Experimental | Behavioral: Telephone-administered coping improvement therapyParticipants will receive telephone-administered coping improvement group therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently living with HIV or AIDS
- Score of 75 or higher on the Mini-Mental Status Examination
Key exclusion criteria (2 listed)
- Active use of drugs and/or alcohol
- Poor cognitive functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-administered coping improvement therapyTelephone-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. | Behavioural | 3 |
| Telephone-administered supportive-expressive therapyTelephone-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. | Behavioural | 2 |
| Individual therapyParticipants 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. | Behavioural | 1 |
Primary outcome
Depression
Time frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up
1 secondary outcome
Coping
Time frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 25090366Heckman 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.
- Derived from this study: PubMed 23474642Heckman 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.
- Derived from this study: PubMed 20857188Heckman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Cale study chair
Ohio University IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Telephone-administered coping improvement therapy, Telephone-administered supportive-expressive therapy and Individual therapy in people with HIV Infections and Depression, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365690, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.