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MBSR + CBT for Chronic Pain (IMPROVE Trial)

N/A
Waitlist Available
Led By David J. Kearney, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must meet criteria for chronic musculoskeletal pain, defined as musculoskeletal pain of low back, cervical spine, or extremities (hip, knee, or shoulder), lasting for at least 3 months
Pain severity (worst or average pain score equal to or greater than 4) as measured using the Brief Pain Inventory (BPI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after completing treatment
Awards & highlights

IMPROVE Trial Summary

This trial is testing whether Mindfulness-Based Stress Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) can help improve quality of life for people with chronic pain.

Who is the study for?
This trial is for veterans with chronic musculoskeletal pain in the lower back, neck, or limbs lasting at least 3 months and having a significant impact on their life. Participants should have moderate to severe pain levels. Those with severe medical conditions, substance abuse disorders, uncontrolled psychotic disorders, recent psychiatric admissions or pending surgeries are excluded.Check my eligibility
What is being tested?
The study compares Mindfulness-Based Stress Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) against usual care in managing chronic pain among veterans. The effectiveness of these non-drug treatments will be measured by changes in functionality and quality of life after six months.See study design
What are the potential side effects?
While MBSR and CBT-CP generally do not involve medication and thus have minimal side effects compared to drugs like opioids, participants may experience emotional discomfort or increased awareness of pain during the process as they learn new coping strategies.

IMPROVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had muscle or joint pain in my back, neck, hip, knee, or shoulder for at least 3 months.
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My worst or average pain score is 4 or more.
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My average pain level has been 3 or more out of 10 in the past week.
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My worst or average pain score is 4 or more, and my daily activities are affected by pain.
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I have low back pain.
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I have been experiencing pain for at least 3 months.

IMPROVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after completing treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after completing treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Interference Subscale of Brief Pain Inventory (BPI)

IMPROVE Trial Design

3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
Group II: Mindfulness-Based Stress Reduction (MBSR)Experimental Treatment1 Intervention
In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
Group III: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Experimental Treatment1 Intervention
Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,386 Total Patients Enrolled
39 Trials studying Chronic Pain
4,540 Patients Enrolled for Chronic Pain
David J. Kearney, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
429 Total Patients Enrolled
Tracy L Simpson, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
2 Previous Clinical Trials
275 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Chronic Pain Clinical Trial Eligibility Overview. Trial Name: NCT04486066 — N/A
Chronic Pain Research Study Groups: Usual Care, Mindfulness-Based Stress Reduction (MBSR), Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Chronic Pain Clinical Trial 2023: Cognitive Behavioral Therapy for Chronic Pain Highlights & Side Effects. Trial Name: NCT04486066 — N/A
Cognitive Behavioral Therapy for Chronic Pain 2023 Treatment Timeline for Medical Study. Trial Name: NCT04486066 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this trial at the present time?

"Affirmative. The details published on clinicaltrials.gov indicate that this research experiment is actively recruiting participants, with first postings dating back to January 27th 2021 and the most recent changes taking place in early January 2022. A total of 222 subjects will be needed from a single site for successful completion of the project."

Answered by AI

Could you provide an estimate of the total number of participants in this experiment?

"Yes, the clinicaltrials.gov website reveals that this trial is actively recruiting participants. Initially posted on January 27th 2021 and last updated on 12/1/2022, it requires 222 patients from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
VA Puget Sound Health Care System Seattle Division, Seattle, WA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Evaluation of MBSR and CBT for Veterans With Chronic Pain
2021. "An Evaluation of MBSR and CBT for Veterans With Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04486066.
All > American Chronic Pain > Pain
~0 spots leftby May 2024
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