NCT04395001

Pain Response Evaluation of a Combined Intervention to Cope Effectively

Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	duloxetine	All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
BEHAVIORAL	Web-based Cognitive Behavioral Therapy (CBT)	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.
OTHER	Nurse-delivered Motivational Interviewing	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.

Timeline

• Start date: 2021-02-24
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2020-05-20
• Last updated: 2025-10-10
• Results posted: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study