Viewing Study NCT04395001



Ignite Creation Date: 2024-05-06 @ 2:40 PM
Last Modification Date: 2024-10-26 @ 1:35 PM
Study NCT ID: NCT04395001
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-14
First Post: 2020-05-15

Brief Title: Pain Response Evaluation of a Combined Intervention to Cope Effectively
Sponsor: Wake Forest University Health Sciences
Organization: Wake Forest University Health Sciences

Study Overview

Official Title: Pain Response Evaluation of a Combined Intervention to Cope Effectively PRECICE
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRECICE
Brief 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 studys intervention is scalable in the future Effective accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1UG3NR019196-01 NIH None httpsreporternihgovquickSearch1UG3NR019196-01