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Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

NCT01769729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-12-05

No results posted yet for this study

Summary

The overall aim of this program of research is to develop a collaborative psychotherapy for major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid chronic low back pain (CLBP).

The purpose of the proposed project is to establish the feasibility and acceptability of a research design for an eventual large-scale randomized clinical trial which would test the efficacy of PEPP in comparison to a control condition (depression care management).

To achieve the investigators specific aims, the investigators will conduct a pilot randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in care management) or care management.

Conditions

Interventions

BEHAVIORAL

PEPP

BEHAVIORAL

Care management

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Lisa Uebelacker, PhD · Butler Hospital, Brown University

  • Risa Weisberg, PhD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769729 on ClinicalTrials.gov