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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
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Telemedicine, Interpersonal Psychotherapy (IPT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Accepts Healthy Volunteers

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

    First Posted
    November 11, 2014
    Last Updated
    October 23, 2018
    Sponsor
    University of Georgia
    Collaborators
    Ohio University, Columbia University
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    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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