Tele-IPT for HIV-Infected Rural Persons

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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV/AIDS
• Intervention / Treatment: Behavioral: IPT

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: IPT; Nine sessions of telephone-administered interpersonal psychotherapy (IPT)
No Intervention: Standard of Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-Intervention, Post-Intervention(one week after completing the 9 week therapy), Four-Month Follow-Up, and Eight Month Follow-Up

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Columbia University; Ohio University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Telemedicine; Interpersonal Psychotherapy (IPT)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2013-10374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No