Learning to Apply Mindfulness to Pain (LAMP)

• ClinicalTrials.gov Identifier: NCT04526158
• Recruitment Status: Recruiting
• First Posted: August 25, 2020
• Last Update Posted: April 19, 2021
• Sponsor: United States Department of Defense
• Information provided by (Responsible Party): Diana J. Burgess, Minneapolis Veterans Affairs Medical Center

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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"

Eligibility Criteria

• 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)

Contacts and Locations

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

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

More 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
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Chronic Pain; Pain; Neurologic Manifestations