NCT02299453

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

November 11, 2014

Last Update Submit

October 23, 2018

Conditions

HIV/AIDSDepression

Keywords

TelemedicineInterpersonal Psychotherapy (IPT)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Standard of Care

NO INTERVENTION

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.

Interventions

IPTBEHAVIORAL

Nine sessions of telephone-administered interpersonal psychotherapy (IPT)

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27115565RESULT

  • 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.

    PMID: 30084893DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepression

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean for Research

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 24, 2014

Study Start

December 1, 2011

Primary Completion

November 1, 2014

Study Completion

December 1, 2015

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share