Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

Depression Clinical Trial

— PEPP - RCT  

Official title:

Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769729
• Other study ID #: MH085762
• Secondary ID: R34MH085762
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: December 4, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: December 2014
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Depression
• Low Back Pain

Intervention

Behavioral:
• PEPP

• Care management

Locations

Country	Name	City	State
United States	Family Care Center of Memorial Hospital	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depression Symptoms	assessment of depression	4 months	No