Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05820204
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-03-16
Brief Title:
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially Ethnically Diverse Adults With Chronic Back Pain
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Feasibility and Acceptability of Pain Reprocessing Therapy in Racially Ethnically Diverse Adults With Chronic Back Pain
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this clinical trial is to learn which treatment works better for adults with chronic pain This study are comparing three treatments Pain Reprocessing Therapy PRT Cognitive Behavioral Therapy CBT and usual care whatever a person is already doing to cope with their pain
The studys main questions are
Does PRT work well for adults with chronic pain
Which treatment works better for lowering pain PRT CBT or usual care
This study will compare PRT CBT and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have
The studys main questions are
Does PRT work well for adults with chronic pain
Which treatment works better for lowering pain PRT CBT or usual care
This study will compare PRT CBT and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have
Detailed Description:
Investigators recently developed a novel psychological treatment pain reprocessing therapy PRT Using a combination of cognitive exposure-based and somatic psychotherapy techniques PRT aims to promote patients reconceptualization of pain as due to reversible non-dangerous brain activity rather than peripheral pathology Critically PRT aims to reduce or eliminate pain rather than increasing functioning
In the first trial of PRT N 151 66 of patients randomized to PRT were pain-free or nearly so at post-treatment as compared to fewer than 20 of placebo and usual care controls This trial was conducted in a primarily White highly-educated population with face-to-face treatment and how PRT effects would generalize to a more diverse population or to telehealth treatment is not known
PRT was developed to better address pain intensity and pain-related outcomes compared to leading psychological treatments for pain such as cognitive behavioral therapy CBT This study aims to yield preliminary findings on the comparative efficacy of PRT vs CBT vs usual care Developing scalable effective non-pharmacological chronic pain treatments and testing their efficacy in racialethnic minorities is an urgent societal need Accordingly this study also tests a remotely-delivered PRT intervention in a diverse patient population
Aim 1 of this study is to test the feasibility recruitment retention of conducting a randomized clinical trial comparing remotely-delivered PRT with an active comparator CBT and usual care and to assess the acceptability helpfulness satisfaction impact of PRT in a diverse lower socioeconomic status SES patient population
Aim 2 of this study is to test the comparative efficacy of PRT vs CBT and PRT vs usual care on pain intensity and other pain-related outcomes
Additional resources became available during the study allowing an increase in sample size from N 75 to N 150 to provide greater statistical power aim 2 comparative efficacy No interim analyses were conducted at any point and investigators remained blind to study outcomes The decision to expand the sample size was made after careful deliberation with Columbia and Cornell Roybal Center Advisory Committees
In the first trial of PRT N 151 66 of patients randomized to PRT were pain-free or nearly so at post-treatment as compared to fewer than 20 of placebo and usual care controls This trial was conducted in a primarily White highly-educated population with face-to-face treatment and how PRT effects would generalize to a more diverse population or to telehealth treatment is not known
PRT was developed to better address pain intensity and pain-related outcomes compared to leading psychological treatments for pain such as cognitive behavioral therapy CBT This study aims to yield preliminary findings on the comparative efficacy of PRT vs CBT vs usual care Developing scalable effective non-pharmacological chronic pain treatments and testing their efficacy in racialethnic minorities is an urgent societal need Accordingly this study also tests a remotely-delivered PRT intervention in a diverse patient population
Aim 1 of this study is to test the feasibility recruitment retention of conducting a randomized clinical trial comparing remotely-delivered PRT with an active comparator CBT and usual care and to assess the acceptability helpfulness satisfaction impact of PRT in a diverse lower socioeconomic status SES patient population
Aim 2 of this study is to test the comparative efficacy of PRT vs CBT and PRT vs usual care on pain intensity and other pain-related outcomes
Additional resources became available during the study allowing an increase in sample size from N 75 to N 150 to provide greater statistical power aim 2 comparative efficacy No interim analyses were conducted at any point and investigators remained blind to study outcomes The decision to expand the sample size was made after careful deliberation with Columbia and Cornell Roybal Center Advisory Committees
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None