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Mindfulness and Cognitive Behavioral Therapy for Chronic Pain (MAP Trial)
N/A
Waitlist Available
Led By Matthew Herbert, PhD
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
Pain most days (> 3 days/week) for at least 6 months
Average pain severity and interference with enjoyment of life and/or general activity rated > 4/10 over the past week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly during treatment (i.e., weeks 1 - 8), and week 9
Awards & highlights
MAP Trial Summary
This trial will develop and test a new 8-week intervention, Mindful Action for Pain, which integrates mindfulness meditation with experiential methods from different evidence-based treatment approaches, in order to help people with chronic pain.
Who is the study for?
This trial is for veterans with chronic, non-terminal pain that's been present most days for at least 6 months and causes significant discomfort or disruption. Participants should rate their pain as more than moderate over the past week. Those with serious medical/psychiatric issues, recent substance abuse, current psychotherapy for pain, or recent treatment changes are excluded.Check my eligibility
What is being tested?
The study is testing a new 8-week group therapy called Mindful Action for Pain (MAP), which combines mindfulness meditation with other strategies to improve functioning despite chronic pain. It will be compared to Cognitive Behavioral Therapy in a pilot randomized controlled trial to see if it's feasible and effective.See study design
What are the potential side effects?
Since MAP involves psychological strategies like mindfulness meditation rather than medication, side effects may include emotional discomfort or increased awareness of painful sensations during practice; however, physical side effects are not expected.
MAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced pain on most days for at least 6 months.
Select...
My pain has been over 4/10 and affects my life and activities.
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I have been diagnosed with a long-lasting pain condition that is not life-threatening.
MAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly during treatment (i.e., weeks 1 - 8) and week 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly during treatment (i.e., weeks 1 - 8) and week 9
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 (BPI) Pain Interference Subscale Change
Secondary outcome measures
Chronic Pain Acceptance Questionnaire (CPAQ)
Five-Factor Mindfulness Questionnaire (FFMQ)
Pain Catastrophizing Scale (PCS)
Other outcome measures
Actigraphy
Meditation diaries
MAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful Action for Pain (MAP) DevelopmentExperimental Treatment1 Intervention
In the first arm, MAP will be fully developed.
Group II: MAP vs. CBT-CPActive Control2 Interventions
In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,477 Total Patients Enrolled
39 Trials studying Chronic Pain
4,631 Patients Enrolled for Chronic Pain
Matthew Herbert, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Chronic Pain
24 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion alone does not provide enough context for me to simplify it. Can you please provide more information about the specific criterion?I haven't changed my pain or mood treatment in the last month.I have not had thoughts of suicide or attempted suicide in the last 3 years.I have experienced pain on most days for at least 6 months.My pain has been over 4/10 and affects my life and activities.I have been diagnosed with a long-lasting pain condition that is not life-threatening.I am currently in group or individual therapy for pain management.
Research Study Groups:
This trial has the following groups:- Group 1: Mindful Action for Pain (MAP) Development
- Group 2: MAP vs. 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation still open to the public?
"Evidenced by the clinicaltrials.gov entry, this study is currently recruiting patients with an inception date of August 28th 2019 and a final edit on March 11th 2022."
Answered by AI
What is the participant count on this experiment?
"Correct. According to clinicaltrials.gov, this research endeavor is currently in the recruitment phase and was first posted on August 28th 2019. The most recent update occurred on March 11th 2022 and 106 individuals are sought from one location."
Answered by AI
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