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Mindfulness-Based Intervention
Mindfulness-Based Interventions for Chronic Pain (LAMP Trial)
N/A
Waitlist Available
Research Sponsored by United States Department of Defense
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 assessed at 10 weeks, 6 months, and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two mindfulness programs to help Veterans with chronic pain. One program uses a mobile app and group sessions, while the other uses just the mobile app. The goal is to teach Veterans mindfulness techniques to manage their pain better. Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain.
Who is the study for?
This trial is for Veterans with chronic pain lasting over 6 months and a severity score of at least 4 out of 10. Participants must have access to a smartphone compatible with the app, internet access, and be available for video conference sessions. Those in other pain studies or with certain mental health conditions are excluded.
What is being tested?
The study tests two mindfulness-based interventions delivered via mobile app: one that's just the app (Mobile LAMP) and another combining the app with group sessions (Mobile+Group LAMP). The goal is to see if these can help reduce chronic pain among Veterans.
What are the potential side effects?
Since this trial involves non-pharmacologic interventions like mindfulness practices through an app, side effects are minimal but may include discomfort or frustration during initial learning or potential stress from technological issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 10 weeks, 6 months, and 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 10 weeks, 6 months, and 12 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the Brief Pain Inventory (BPI) interference score from baseline, over the 12-month follow-up period.
Secondary study objectives
BPI Interference Score Responder Analysis
Change in Post Traumatic Stress Disorder (PTSD), over the 12-month follow-up period, assessed by participants' scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5)
Change in anxiety over the 12-month follow-up period assessed by mean score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mobile+Group LAMP Mindfulness-Based InterventionExperimental Treatment1 Intervention
8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.
Group II: Mobile LAMP Mindfulness-Based InterventionExperimental Treatment1 Intervention
8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.
Group III: Usual CareActive Control1 Intervention
Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for chronic pain, particularly non-pharmacologic evidence-based strategies, work through various mechanisms. Exercise therapy improves physical function and reduces pain by strengthening muscles and enhancing flexibility.
Cognitive Behavioral Therapy (CBT) addresses the psychological aspects of pain, helping patients reframe negative thoughts and develop coping strategies. Mindfulness-Based Stress Reduction (MBSR) and other mind-body interventions like yoga and Tai-chi combine physical movement with mental focus, reducing stress and improving pain perception.
These approaches are essential for chronic pain patients as they provide holistic pain management, encouraging active participation in their care and potentially leading to better outcomes and enhanced quality of life.
Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.
Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.
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Who is running the clinical trial?
United States Department of DefenseLead Sponsor
906 Previous Clinical Trials
332,559 Total Patients Enrolled
11 Trials studying Chronic Pain
1,884 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently participating in a program called mindfulness-based stress reduction (MBSR).You have been diagnosed with schizophrenia, bipolar disorder, major depressive disorder, or other psychosis in the past 18 months, or you currently have severe mental health symptoms that are not well controlled.You are currently taking part in a research study for treating pain.You must have been diagnosed with the same type of pain at least twice, with at least 90 days between each diagnosis, in the last 2 years.You have had pain for at least 6 months and your pain is pretty bad, scoring 4 or higher on a scale from 0 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile+Group LAMP Mindfulness-Based Intervention
- Group 2: Mobile LAMP Mindfulness-Based Intervention
- Group 3: Usual Care
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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