Pain Response Evaluation of a Combined Intervention to Cope Effectively

PHASE4CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

February 24, 2021

Primary Completion Date

July 18, 2024

Study Completion Date

July 18, 2024

Conditions
Chronic Pain
Interventions
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.

Trial Locations (1)

27157

Wake Forest Baptist Health Department of Rheumatology, Winston-Salem

All Listed Sponsors
collaborator

National Institute of Nursing Research (NINR)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT04395001 - Pain Response Evaluation of a Combined Intervention to Cope Effectively | Biotech Hunter | Biotech Hunter