Tele-IPT for HIV-Infected Rural Persons
Primary Purpose
HIV/AIDS, Depression
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IPT
Sponsored by

About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring Telemedicine, Interpersonal Psychotherapy (IPT)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02299453
First Posted
November 11, 2014
Last Updated
October 23, 2018
Sponsor
University of Georgia
Collaborators
Ohio University, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT02299453
Brief Title
Tele-IPT for HIV-Infected Rural Persons
Official Title
Telephone IPT Intervention for HIV-Infected Rural Persons
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Ohio University, Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Depression
Keywords
Telemedicine, Interpersonal Psychotherapy (IPT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IPT
Intervention Description
Nine sessions of telephone-administered interpersonal psychotherapy (IPT)
Primary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
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.
Time Frame
Pre-Intervention, Post-Intervention(one week after completing the 9 week therapy), Four-Month Follow-Up, and Eight Month Follow-Up
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27115565
Citation
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.
Results Reference
result
PubMed Identifier
30084893
Citation
Heckman 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.
Results Reference
derived
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Tele-IPT for HIV-Infected Rural Persons
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