HIV/AIDSPhase 1/2NCT02299453
Tele-IPT for HIV-Infected Rural Persons
A Phase 1/2 study testing IPT in people with HIV/AIDS and Depression, run by University of Georgia.
Trial summary
This randomized clinical trial is testing if telephone-administered interpersonal psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Depression
- What is being tested?
- IPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to 1 Dec 2015
- Phase
- Phase 1/2
- 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 18 years and older
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-plus years of age;
- a diagnosis of HIV infection or AIDS;
- residence in a county with a Department of Agriculture Rural-Urban Continuum Code of "6," "7," "8," or "9";
- a diagnosis of Major Depressive Disorder (MDD), Partial Remission of MDD, or Dysthymia based on the Mood Module of the "Primary Care Evaluation of Mental Disorders;
- the participant does not expect to leave his or her current place of rural residence within the next year; and
- provision of informed consent.
Who cannot join
- serious cognitive or neuropsychiatric impairment;
- being diagnosed with, or currently taking medications for, bipolar disorder;
- being diagnosed with, or currently taking medications for, psychotic disorder.
About this study
Official title: Telephone IPT Intervention for HIV-Infected Rural Persons
This randomized clinical trial is testing if telephone-administered interpersonal psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.
Read the detailed description
Compared to their urban counterparts, HIV-rural persons are more likely to be diagnosed with depression, less likely to seek assistance from mental health professionals, and appear to have shorter periods of survival. This application responds to PA-07-103 ("Research on Rural Mental Health and Drug Abuse Disorders") and the PA's stated need for research that will "Study whether individuals with various mental disorders can be treated effectively via telemedicine." A pilot RCT recently completed by our team showed that a 6-session telephone-delivered, interpersonal psychotherapy (IPT) intervention reduced depressive symptoms in 79 HIV- infected rural persons (Ransom, Heckman, et al., 2008, Psychiatric Services). This follow-up RCT will enroll 180 persons living with HIV/AIDS in rural counties in the United States who are diagnosed with depression via telephone interviews. Participants will complete self-administered surveys at pre-intervention, post- intervention, and 4- and 8-month follow-up that assess depressive symptoms (the primary outcome measure), interpersonal problems, social support, and ART adherence. Participants will also provide weekly data (for 41 weeks) via interactive voice response (IVR) systems that assess depressive symptoms (41 weeks) and therapeutic alliance (9 weeks). Ninety (n=90) participants will be randomly assigned to a 9-session, one-on- one, telephone-delivered, IPT intervention and 90 will be assigned to a usual care comparison group. Linear mixed models (LMM) will test if IPT participants report greater reductions in depressive symptoms compared to usual care controls. Analyses of reliable change will test if a greater proportion of IPT participants report clinically-significant reductions in depressive symptoms compared to usual care controls. Using weekly data collected via IVR systems, time series analyses will test if IPT participants report greater decreases in depressive symptoms over a 41-week follow-up period compared to usual care control. Mixed models analyses will assess the importance of therapeutic alliance in telephone-delivered IPT. Public Health Significance: This study will test if nine sessions of telephone-administered interpersonal psychotherapy can reduce depressive symptoms in HIV-infected rural persons, a group that is increasing in size and that experiences great difficulty accessing mental health support services.
- Conditions
- HIV/AIDS, Depression
- Being tested
- IPT
- Keywords
- Telemedicine, Interpersonal Psychotherapy (IPT)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPTBehavioural
Nine sessions of telephone-administered interpersonal psychotherapy (IPT)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants receive 9 sessions of telephone-administered PT and have access to standard community-based services. As part of the 9 sessions, participants discuss the extent to which interpersonal issues such as bereavements, role transitions, interpersonal disputes, and relationship difficulties may be related to their depression. Receives: Behavioral: IPT |
| Standard of Care | No intervention | Participants receive no active intervention but do have access to standard community-based services, such as individual therapy, support groups, 12-step programs, and other social serves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms
Self-administered surveys. Pre-intervention surveys are administered one week before therapy is initiated. Post-intervention surveys are administered one week after completing the 9 week therapy. Four-month follow-ups occur 4 months after the last therapy session and 8-month follow-ups are completed 8 months after the final therapy session. Control participants complete all four measures with their time-matched experimental participant.
Measured: Pre-Intervention, Post-Intervention(one week after completing the 9 week therapy), Four-Month Follow-Up, and Eight 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 posted24 Nov 2014 (estimated)
- Study startDec 2011
- Primary completionNov 2014
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio University, Columbia University
- Responsible party
- Principal investigator, Timothy G. Heckman, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299453
- Sponsor's protocol ID
- 2013-10374
- Status last verified
- Oct 2018
- First submitted
- 11 Nov 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Markowitz JC, Shen Y, Sutton M. Tele-Interpersonal Psychotherapy Acutely Reduces Depressive Symptoms in Depressed HIV-Infected Rural Persons: A Randomized Clinical Trial. Behav Med. 2017 Oct-Dec;43(4):285-295. doi: 10.1080/08964289.2016.1160025. Epub 2016 Apr 26.
PubMed 27115565Heckman TG, Markowitz JC, Heckman BD, Woldu H, Anderson T, Lovejoy TI, Shen Y, Sutton M, Yarber W. A Randomized Clinical Trial Showing Persisting Reductions in Depressive Symptoms in HIV-Infected Rural Adults Following Brief Telephone-Administered Interpersonal Psychotherapy. Ann Behav Med. 2018 Mar 15;52(4):299-308. doi: 10.1093/abm/kax015.
PubMed 30084893
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone IPT Intervention for HIV-Infected Rural Persons
- ClinicalTrials.gov ID
- NCT02299453
- Acronym / sponsor ID
- 2013-10374
- Conditions
- HIV/AIDS, Depression
- Keywords
- Telemedicine, Interpersonal Psychotherapy (IPT)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Ohio University, Columbia University
- Study start
- Dec 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 24 Nov 2014 (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 randomized clinical trial is testing if telephone-administered interpersonal psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.
Detailed description
Compared to their urban counterparts, HIV-rural persons are more likely to be diagnosed with depression, less likely to seek assistance from mental health professionals, and appear to have shorter periods of survival. This application responds to PA-07-103 ("Research on Rural Mental Health and Drug Abuse Disorders") and the PA's stated need for research that will "Study whether individuals with various mental disorders can be treated effectively via telemedicine." A pilot RCT recently completed by our team showed that a 6-session telephone-delivered, interpersonal psychotherapy (IPT) intervention reduced depressive symptoms in 79 HIV- infected rural persons (Ransom, Heckman, et al., 2008, Psychiatric Services). This follow-up RCT will enroll 180 persons living with HIV/AIDS in rural counties in the United States who are diagnosed with depression via telephone interviews. Participants will complete self-administered surveys at pre-intervention, post- intervention, and 4- and 8-month follow-up that assess depressive symptoms (the primary outcome measure), interpersonal problems, social support, and ART adherence. Participants will also provide weekly data (for 41 weeks) via interactive voice response (IVR) systems that assess depressive symptoms (41 weeks) and therapeutic alliance (9 weeks). Ninety (n=90) participants will be randomly assigned to a 9-session, one-on- one, telephone-delivered, IPT intervention and 90 will be assigned to a usual care comparison group. Linear mixed models (LMM) will test if IPT participants report greater reductions in depressive symptoms compared to usual care controls. Analyses of reliable change will test if a greater proportion of IPT participants report clinically-significant reductions in depressive symptoms compared to usual care controls. Using weekly data collected via IVR systems, time series analyses will test if IPT participants report greater decreases in depressive symptoms over a 41-week follow-up period compared to usual care control. Mixed models analyses will assess the importance of therapeutic alliance in telephone-delivered IPT. Public Health Significance: This study will test if nine sessions of telephone-administered interpersonal psychotherapy can reduce depressive symptoms in HIV-infected rural persons, a group that is increasing in size and that experiences great difficulty accessing mental health support services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: IPTParticipants receive 9 sessions of telephone-administered PT and have access to standard community-based services. As part of the 9 sessions, participants discuss the extent to which interpersonal issues such as bereavements, role transitions, interpersonal disputes, and relationship difficulties may be related to their depression. |
| Standard of Care | No intervention | –Participants receive no active intervention but do have access to standard community-based services, such as individual therapy, support groups, 12-step programs, and other social serves. |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-plus years of age;
- a diagnosis of HIV infection or AIDS;
- residence in a county with a Department of Agriculture Rural-Urban Continuum Code of "6," "7," "8," or "9";
- a diagnosis of Major Depressive Disorder (MDD), Partial Remission of MDD, or Dysthymia based on the Mood Module of the "Primary Care Evaluation of Mental Disorders;
- the participant does not expect to leave his or her current place of rural residence within the next year; and
Key exclusion criteria (3 listed)
- serious cognitive or neuropsychiatric impairment;
- being diagnosed with, or currently taking medications for, bipolar disorder;
- being diagnosed with, or currently taking medications for, psychotic disorder.
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 |
|---|---|---|
| IPTNine sessions of telephone-administered interpersonal psychotherapy (IPT) | Behavioural | Experimental |
Primary outcome
Changes in depressive symptoms
Time frame: Pre-Intervention, Post-Intervention(one week after completing the 9 week therapy), Four-Month Follow-Up, and Eight Month Follow-Up
Self-administered surveys. Pre-intervention surveys are administered one week before therapy is initiated. Post-intervention surveys are administered one week after completing the 9 week therapy. Four-month follow-ups occur 4 months after the last therapy session and 8-month follow-ups are completed 8 months after the final therapy session. Control participants complete all four measures with their time-matched experimental participant.
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 25 Oct 2018.
- Results publication: PubMed 27115565Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Markowitz JC, Shen Y, Sutton M. Tele-Interpersonal Psychotherapy Acutely Reduces Depressive Symptoms in Depressed HIV-Infected Rural Persons: A Randomized Clinical Trial. Behav Med. 2017 Oct-Dec;43(4):285-295. doi: 10.1080/08964289.2016.1160025. Epub 2016 Apr 26.
- Derived from this study: PubMed 30084893Heckman TG, Markowitz JC, Heckman BD, Woldu H, Anderson T, Lovejoy TI, Shen Y, Sutton M, Yarber W. A Randomized Clinical Trial Showing Persisting Reductions in Depressive Symptoms in HIV-Infected Rural Adults Following Brief Telephone-Administered Interpersonal Psychotherapy. Ann Behav Med. 2018 Mar 15;52(4):299-308. doi: 10.1093/abm/kax015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPT in people with HIV/AIDS and Depression, run by University of Georgia.
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 6 inclusion and 3 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in depressive symptoms (time frame: Pre-Intervention, Post-Intervention(one week after completing the 9 week therapy), Four-Month Follow-Up, and Eight 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 NCT02299453, which also lists 2 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 25 Oct 2018.