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Cognitive Behavioral Therapy for Chronic Pain (COPES ExTRA Trial)
N/A
Waitlist Available
Led By Alicia Heapy, Phd
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
COPES ExTRA Trial Summary
This trial is testing whether COPES, a new type of therapy, is better than the standard therapy for chronic pain that is currently used in the Veterans Health Administration.
Who is the study for?
This trial is for Veterans Health Administration patients with chronic musculoskeletal pain who can walk at least one block and don't have severe cognitive impairment, serious mental illness requiring recent hospitalization, active cancer, or are in hospice care. They must have moderate pain for a year and be able to use a phone without vision or hearing issues.Check my eligibility
What is being tested?
The COPES ExTRA trial is testing whether the COPES program is better than the standard Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) offered by the VHA. It's focused on helping veterans manage their long-term musculoskeletal pain more effectively.See study design
What are the potential side effects?
Since this trial involves educational and self-management programs rather than medication, traditional side effects like those seen with drugs are not expected. Participants may experience discomfort from increased activity during the walking portion.
COPES ExTRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Pain Inventory
Secondary outcome measures
Current Pain Intensity Rating
Depression symptom severity
Health-Related Quality of Life
+5 moreCOPES ExTRA Trial Design
2Treatment groups
Active Control
Group I: data from veterans using CBT-CPActive Control1 Intervention
Data from veterans using CBT-CP for chronic pain
Group II: data from veterans using COPESActive Control1 Intervention
Data from veterans using COPES for chronic pain
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,737,557 Total Patients Enrolled
14 Trials studying Chronic Pain
1,966 Patients Enrolled for Chronic Pain
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,209 Total Patients Enrolled
45 Trials studying Chronic Pain
17,245 Patients Enrolled for Chronic Pain
Alicia Heapy, PhdPrincipal InvestigatorVA Office of Research and Development
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving treatment for long-term pain in your muscles or bones within the Veterans Health Administration (VHA) system.You can safely walk at least one block and do not have diabetic foot ulcers.You do not have a diagnosis of cancer or are receiving end-of-life care.You don't have a diagnosis of severe memory or thinking problems.You do not have cancer or are currently receiving end-of-life care.You have had moderate or worse chronic pain (rated at least 4 out of 10) for at least three months in the past year.You have had ongoing moderate to severe chronic pain, with pain scores of 4 or higher on a scale, for at least a year.You have ongoing musculoskeletal pain and are receiving care through the Veterans Health Administration (VHA).You have a diagnosis related to pain and muscle or bone issues in your electronic health records.You can walk at least one block safely and do not have diabetic foot ulcers.
Research Study Groups:
This trial has the following groups:- Group 1: data from veterans using CBT-CP
- Group 2: data from veterans using COPES
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many distinct geographic areas is this scientific investigation being conducted?
"Several medical institutions are involved in this trial, namely VA Puget Sound Healthcare System located in Seattle, Edward Hines Jr. VA Hospital situated at Hines and VA Central Western Massachusetts based out of Leeds. Furthermore, 6 other sites are also recruiting patients for the experiment."
Answered by AI
How many participants are being monitored as part of this research experiment?
"In order to realize this medical experiment, 723 patients must sign up and adhere to the necessary conditions. These individuals can register at VA Puget Sound Healthcare System in Seattle or VA Central Western Massachusetts in Leeds."
Answered by AI
Are any individuals being accepted into this research trial presently?
"Affirmative. Clinicaltrials.gov contains evidence that this trial—which was initially listed on December 27th 2019—is still recruiting participants, with nearly 800 people needed from 9 distinct medical centers."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
What site did they apply to?
VA Ann Arbor Healthcare System
Oklahoma City VA Health Care System
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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