CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 280 enrolled
Drug / intervention
duloxetine +2 moredrug
Likely dose
duloxetine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04395001
NCT04395001Phase 4Completed
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Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

Wake Forest University Health Sciences·interventional·Posted May 20, 2020·Updated Oct 10, 2025

In Brief

A Phase 4 clinical trial evaluating duloxetine, Web-based Cognitive Behavioral Therapy (CBT), and 1 other intervention for Chronic Pain. Completed, enrolled 280 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR)

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 20, 2020
Enrollment StartFeb 24, 2021
Primary CompletionJul 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.1 years ago

Interventions

duloxetinedrug

All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.

Web-based Cognitive Behavioral Therapy (CBT)behavioral

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.

Nurse-delivered Motivational Interviewingother

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.