Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

Not Applicable

Completed

Interventions: Behavioral: Cognitive behavioral therapy
Behavioral: Pain self-management program
Drug: Co-Analgesic Therapy
Drug: Opioid Analgesics

Brief Summary: The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain:

1. Stepped care is more effective than usual care in reducing pain-related disability

2. Stepped care is more effective than usual care in reducing psychological distress

Detailed Description: Through the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial we aim to develop and test a stepped-care intervention to improve functional and work-related outcomes in Operation Iraqi Freedom/Operation Enduring Freedom veterans with chronic musculoskeletal pain. Stepped-care involves starting with lower intensity, less costly treatments initially (Step 1) and "stepping up" to more intensive, costly, or complex treatments in patients with inadequate response (Step 2). The study design will be a randomized controlled trial. The stepped care approach will involve 12 weeks of a pain self-management program in Step 1 followed by 12 weeks of brief cognitive behavioral therapy in participants with inadequate improvement in pain-related disability (Step 2). Patients treated in usual care will be the control group. Thus, the primary objective of the ESCAPE trial is to conduct a randomized controlled trial to compare the effectiveness of a stepped care intervention vs. usual care in OIF/OEF veterans with chronic and disabling musculoskeletal pain and evaluate the impact of this intervention on pain-related disability, work function, psychological distress, and secondary outcomes.

Recruitment & Eligibility

Inclusion Criteria

have musculoskeletal pain of the low back, cervical spine, or extremities
have chronic pain (>3 months duration)
have moderate functional impairment
have access to a working telephone
Indianapolis Roudebush VA Medical Center patient or Walter Reed Army Medical Center patient
willing to travel at least once to study site

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Stepped Care	Pain self-management program	Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Stepped Care	Cognitive behavioral therapy	Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Stepped Care	Co-Analgesic Therapy	Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.
Stepped Care	Opioid Analgesics	Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.

Primary Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire	at baseline and 9 months	This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.
Brief Pain Inventory (Interference)	Baseline and 9 months	This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7).

Secondary Outcome Measures

Name	Time	Method
SF-Mental Component Summary (MCS)	Baseline and 9 months	This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health
PHQ-9 Depression	Baseline and 9 months	This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression
PTSD Checklist-17 Civilian Version (PCL-C)	Baseline and 9 months	The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms.
GAD-7 Anxiety Score	Baseline and 9 months	This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms
Pain Catastrophizing Scale (PCS)	Baseline and 9 months	The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing.