Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Learning to Apply Mindfulness to Pain (LAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526158
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Diana J. Burgess, Minneapolis Veterans Affairs Medical Center

Brief Summary:
The long-term goal of this two-phase project is to reduce chronic pain and co-morbid conditions among Veterans, through scalable, non-pharmacologic evidence-based strategies that are "Veteran-Centric," designed to optimize engagement, adherence and sustainability, and are deliverable to large numbers of Veterans.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention Behavioral: Mobile LAMP Mindfulness-Based Intervention Not Applicable

Detailed Description:
The investigators will conduct a 4-site 3-arm pragmatic clinical trial (N = 750) to test effectiveness of 2 Mindfulness-Based Interventions (MBIs), Mobile+Group LAMP and Mobile LAMP, compared to usual practice. Effectiveness will be assessed by pain functioning over the 12-month follow-up period using the Brief Pain Inventory (BPI) interference score. The investigators will test the following primary hypotheses: (1) Mobile LAMP will be more effective at improving chronic pain (as measured by change in the BPI interference score over the 12-month follow-up period) compared to usual practice, (2) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference score change over the 12-month follow-up period) compared to usual practice, and (3) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference change over the 12-month follow-up period) compared to Mobile LAMP without the group component. The investigators will test the following secondary hypotheses: (1) Comparison of intervention group with secondary outcomes listed below, and (2) primary and secondary hypotheses comparisons will be confirmed in gender-specific strata. The primary outcome will be measured as change in BPI interference score over the 12-month follow-up period. Secondary outcomes will include patient-reported measures related to pain, comorbid mental health conditions and function, expected mediators of treatment effects, patient satisfaction, and adverse effects and measures captured in electronic health records. These outcomes will be assessed at 10 weeks, 6 months and 12 months. Implementation data will be collected and described, using the guided Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three arm parallel assignment design
Masking: None (Open Label)
Masking Description: The randomization list will be concealed from the research team within the tracking portal, so team members will not know the next study assignment. Permuted blocks will be used to aid in the concealment of treatment assignment while ensuring balance in treatment arms across time.
Primary Purpose: Treatment
Official Title: Testing Two Scalable, Veteran-centric Mindfulness-based Interventions for Chronic Musculoskeletal Pain: A Pragmatic, Multisite Trial
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Mobile+Group LAMP Mindfulness-Based Intervention
8 weekly interactive online group sessions and access to mobile app
Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention
The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of 8, 90-minute weekly group sessions, delivered via secure video-conferencing. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to the mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions.
Other Name: Mobile+Group LAMP

Experimental: Mobile LAMP Mindfulness-Based Intervention
8 weekly asynchronous sessions, delivered on mobile app
Behavioral: Mobile LAMP Mindfulness-Based Intervention
The Mobile LAMP Mindfulness-Based Intervention (MBI) condition consists of 8, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own. Participants will also participate in 3 phone sessions with a facilitator at the beginning, middle, and end of the program.
Other Name: Mobile LAMP

No Intervention: Usual Care
The Usual Care arm will not get access to either intervention



Primary Outcome Measures :
  1. Change in the Brief Pain Inventory (BPI) interference score from baseline, over the 12-month follow-up period. [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months, to capture short-term, mid-term, and long-term effects ]
    Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.


Secondary Outcome Measures :
  1. Change in the Brief Pain Inventory (BPI) intensity score from baseline, over the 12-month follow-up period. [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months, to capture short-term, mid-term, and long-term effects ]
    Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.

  2. Change in physical functioning over the 12-month follow-up period, assessed at 10 weeks, 6 months, and 12 months, using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 1. Maximum value: 5. Lower scores indicate worse physical functioning

  3. 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 [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 1. Maximum value: 5. Higher scores indicate worse anxiety

  4. Change in fatigue 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 fatigue [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 1. Maximum value:5. Higher scores indicate worse fatigue

  5. Change in fatigue 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 sleep disturbance [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 1. Maximum value: 5. Higher scores indicate worse sleep disturbance

  6. Change in participation in social roles and activities over the 12-month follow-up period assessed by mean score on the PROMIS-29 Profile v.2.0 measure of participation in social roles and activities [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 1. Maximum value: 5. Higher scores indicate greater participation in social roles and activities

  7. Change in depression over the 12-month follow-up period assessed by score on the eight-item Patient Health Questionnaire depression scale (PHQ8) [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression

  8. 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) [ Time Frame: Assessed at baseline, 10 weeks, 6 months, and 12 months ]
    Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD

  9. Mean global improvement of pain score, over the 12-month follow-up period [ Time Frame: Assessed at 10 weeks, 6 months, and 12 months ]
    Global impression of change scale from "much better" to "much worse"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have qualifying pain diagnoses on at least 2 occasions, at least 90 days apart, within the same pain category, during the previous 2 years
  • Must report having a pain duration of ≥ 6 months (pain chronicity threshold), and a pain severity score of ≥ 4 on the 0-10 Numeric Rating Scale (pain severity threshold).
  • Must have access to a smart phone that meets the requirement of the mobile app software
  • Must be willing and able to download the mobile app on their phone
  • Must have wireless or cellular internet access on a daily basis
  • Must be willing to meet via video conference on the dates and at the time when Mobile+Group LAMP sessions are held, and attend all sessions of the arm to which they are randomized.

Exclusion Criteria:

  • diagnoses of schizophrenia, bipolar disorder, or other psychosis within the past 18 months in electronic health record
  • active psychotic symptoms, suicidality, severe depression, and/or active manic episode or poorly controlled bipolar disorder (as assessed by a medical chart review)
  • currently enrolled in a research study for pain
  • currently enrolled in mindfulness-based stress reduction (MBSR)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526158


Contacts
Layout table for location contacts
Contact: Mariah C Branson, BA 612-467-4920 ext 4920 mariah.branson@va.gov
Contact: Diana Burgess, PhD 612-467-1591 ext 1591 diana.burgess@va.gov

Locations
Layout table for location information
United States, Minnesota
Minnesota Veteran Administration Health Care System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Lee Cross, MPH    612-629-7568 ext 317568    lee.cross@va.gov   
Contact: Mariah Branson, BA    612-467-4920 ext 314920    mariah.branson@va.gov   
Principal Investigator: Diana Burgess, PhD         
Sponsors and Collaborators
United States Department of Defense
Layout table for additonal information
Responsible Party: Diana J. Burgess, Principal Investigator, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT04526158    
Other Study ID Numbers: #NH170001
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diana J. Burgess, Minneapolis Veterans Affairs Medical Center:
Mindfulness
Veteran
Chronic pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations