Tele-IPT for HIV-Infected Rural Persons

Depression Clinical Trial

Official title:

Telephone IPT Intervention for HIV-Infected Rural Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299453
• Other study ID #: 2013-10374
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2011
• Est. completion date: December 1, 2015

Study information

• Verified date: October 2018
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial is testing if telephone-administered interpersonal psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 1, 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• HIV/AIDS

Intervention

Behavioral:
• IPT
Nine sessions of telephone-administered interpersonal psychotherapy (IPT)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Georgia	Columbia University, Ohio University

References & Publications (1)

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):285-29 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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