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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)
Must not have
Current bipolar affective disorder with mania
Inpatient psychiatric admission within the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after completing treatment
Awards & highlights
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
Select...
I have been experiencing pain for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have bipolar disorder with current manic episodes.
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I have not been admitted to a psychiatric unit in the last month.
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I do not have severe medical conditions that limit my activities.
Select...
I am scheduled for back surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after completing treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after completing treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Interference Subscale of Brief Pain Inventory (BPI)
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
Cognitive Behavioral Therapy for Chronic Pain
2019
N/A
~130
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,853 Total Patients Enrolled
41 Trials studying Chronic Pain
4,964 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a problem with using opioids or other drugs.I have bipolar disorder with current manic episodes.My condition involves my neck, hip, knee, or shoulder.I have had muscle or joint pain in my back, neck, hip, knee, or shoulder for at least 3 months.My worst or average pain score is 4 or more.My average pain level has been 3 or more out of 10 in the past week.My worst or average pain score is 4 or more, and my daily activities are affected by pain.I have not been admitted to a psychiatric unit in the last month.I do not have severe medical conditions that limit my activities.You have a history of severe alcohol-related seizures or delirium tremens within the past year.You have a severe mental illness that is not under control.I have low back pain.You have had thoughts of hurting yourself or someone else with a plan in the last month.I am scheduled for back surgery.You have previously taken part in mindfulness-based stress reduction (MBSR) or cognitive behavioral therapy for chronic pain (CBT-CP).I have been experiencing pain for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Mindfulness-Based Stress Reduction (MBSR)
- Group 3: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
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.
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