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Completed

NCT Number: NCT02299453

Tele-IPT 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPT

Behavioral

Nine sessions of telephone-administered interpersonal psychotherapy (IPT)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Columbia University
  • Ohio University

Registry information

Official study title

Telephone IPT Intervention for HIV-Infected Rural Persons

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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