Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

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.

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