Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

NCT01769729 | Completed DMC

• 2 other identifiers: MH085762R34MH085762
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Chronic Low Back Pain

Keywords

integrated primary care; depression; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depression Symptoms

  assessment of depression

  4 months

Study Arms (2)

PEPP + care management

EXPERIMENTAL

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

Care management alone

ACTIVE COMPARATOR

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

Behavioral: Care management

Interventions

PEPP BEHAVIORAL

PEPP + care management

Care management BEHAVIORAL

Care management alone; PEPP + care management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for current major depressive disorder.
• Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score \>11.
• 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))
• 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.
• 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.
• Aged 18 or older.
• Have a PCP at one of our enrollment sites.

You may not qualify if:

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

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Family Care Center of Memorial Hospital

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Depression

Interventions

CDRI 85-287

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital, Brown University

  PRINCIPAL INVESTIGATOR

• Risa Weisberg, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)