The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP).
With this study, the study team hopes to address two important unanswered questions: (1) Does combination treatment consisting of duloxetine and web-based Cognitive Behavioral Therapy (CBT) optimize treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
Wake Forest Baptist Health Department of Rheumatology
Winston-Salem, North Carolina, United States
Brief Pain Inventory (BPI) Total Pain Severity
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time frame: Baseline
Brief Pain Inventory (BPI) Total Pain Severity
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time frame: week 13 of treatment phase
Brief Pain Inventory (BPI)
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time frame: week 25 of treatment phase
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Time frame: week 25 of treatment phase
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
Score is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Time frame: week 25 of treatment phase
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: week 25 of treatment phase