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Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial (PEPP - RCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769729
First Posted: January 17, 2013
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Butler Hospital
  Purpose

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.


Condition Intervention
Depression Chronic Low Back Pain Behavioral: PEPP Behavioral: Care management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Quick Inventory of Depression Symptoms [ Time Frame: 4 months ]
    assessment of depression


Estimated Enrollment: 30
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEPP + care management

This 4-month collaborative psychotherapy, entitled Program for Emotional and Physical Pain (PEPP), will include 1 joint meetings with the behavioral health specialist (BHS), primary care provider (PCP), and patient, 10 psychotherapy sessions, and continued collaboration between the BHS and the PCP to assure a shared treatment plan.

Care management will include monthly calls with a depression care manager.

Behavioral: PEPP Behavioral: Care management
Active Comparator: Care management alone
Care management will include monthly calls with a depression care manager.
Behavioral: Care management

Detailed Description:

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 newly developed intervention will integrate and build on behavior therapy for MDD and behavior therapy for chronic pain towards a key target of reducing behavioral avoidance. This 4-month collaborative psychotherapy, entitled Program for Emotional and Physical Pain (PEPP), will include 1 joint meeting with the behavioral health specialist (BHS), primary care provider (PCP), and patient, 10 psychotherapy sessions, and continued collaboration between the BHS and the PCP to assure a shared treatment plan.

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. The specific aims are:

  1. To develop and refine PEPP so that it meets standards of feasibility and acceptability for primary care physicians (PCPs), behavioral health specialists (BHSs), and participants;

    1. To develop, field-test, and finalize a PEPP manual;
    2. To develop a reliable measure of BHS adherence to the manual;
    3. To develop, field-test, and finalize BHS training and supervision procedures;
  2. To field-test and finalize procedures for depression care management;
  3. To establish that the investigators can adequately provide depression care management and that it is acceptable in this population;
  4. To develop and refine recruitment methods for an RCT and document an adequate rate of recruitment;
  5. To refine research procedures, e.g., consent process, randomization process, and assessment procedures, and establish their feasibility and acceptability to participants.

Ultimately, the investigators expect that this treatment development work will prepare us to apply for an R01 to conduct a large-scale, adequately powered RCT with the same research design as the pilot RCT proposed in this application. Depression will be the primary outcome variable assessed in the large-scale RCT; pain will be a secondary outcome variable. In the end, the investigators believe this line of work will lead to the incorporation into primary care of theoretically-driven and effective mental health treatment for patients with MDD and comorbid CLBP. To the best of the investigators knowledge, this would be the first empirically-tested psychotherapy protocol that specifically integrates treatment of major depression with CLBP.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meets DSM-IV criteria for current major depressive disorder.
  2. Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score >11.
  3. Chronic low back pain. Pain must be > 6 months duration, in the low back (lumbar region), present > ½ the days of the month, and, on average, be of at least a moderate level of severity in the last month (> 4 on an 11-point numerical rating of pain intensity ranging from 0 [no pain] to10 [worst pain imaginable]. Pain-related disability / functional impact of pain must be of at least moderate severity at the time of intake, determined by a score of at > 7 on the Roland Morris Disability Questionnaire (RMDQ; (Roland & Morris, 1983))
  4. Continued pain despite having attempted initial steps of PCP guideline-based care (Chou et al., 2007). Participants must have been under the care of a physician for low back pain for > 6 months and have already had > 2 trials of recommended medications (i.e., acetaminophen, NSAIDs, skeletal muscle relaxants, opioids, and/or benzodiazepines).This will be judged through chart review and interviews with patients & PCPs.
  5. Antidepressant dose stable for previous 2 months. If the participant is taking an antidepressant, he/ she must have been on the same dose for the previous 2 months.
  6. Aged 18 or older.
  7. Have a PCP at one of our enrollment sites.

Exclusion Criteria:

  1. Lifetime diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition.
  2. Current hazardous illicit drug or alcohol use assessed with the AUDIT and DUDIT.
  3. Opiate misuse will be assessed with the COMM and via primary care chart review.
  4. Suicidal ideation or behavior requiring immediate attention.
  5. In psychotherapy or in a multidisciplinary pain management program at baseline.
  6. Anticipate having surgery in the next 6 months.
  7. Pain thought to be due to visceral disease, cancer, infection, or inflammatory arthritis or pain associated with severe or progressive neurological deficits.
  8. Current pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769729


Locations
United States, Rhode Island
Family Care Center of Memorial Hospital
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lisa Uebelacker, PhD Butler Hospital, Brown University
Principal Investigator: Risa Weisberg, PhD Brown University
  More Information

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01769729     History of Changes
Other Study ID Numbers: MH085762
R34MH085762 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2013
First Posted: January 17, 2013
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Butler Hospital:
integrated primary care
depression
chronic low back pain

Additional relevant MeSH terms:
Depression
Back Pain
Low Back Pain
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms