Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial
Completed · Not applicable
Conditions studied: Depression, Chronic Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT01769729
- Run by
- Butler Hospital
- People needed
- 30
- Starts
- 2012-12-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2014-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Family Care Center of Memorial Hospital — Pawtucket, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.