Clinical trial NCT04526158: Learning to Apply Mindfulness to Pain
Official title: Testing Two Scalable, Veteran-centric Mindfulness-based Interventions for Chronic Musculoskeletal Pain: A Pragmatic, Multisite Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness
Veteran
Chronic pain
Lead sponsor: United States Department of Defense
Sponsor class: FED
First posted: 2020-08-25
Enrollment: 811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm parallel assignment design
Primary purpose: TREATMENT

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.

Detailed description: The investigators will conduct a 3-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 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.

Eligibility 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:

* new diagnosis of schizophrenia, bipolar disorder, major depressive disorder, or other psychosis within the past 18 months; or current active psychotic symptoms, suicidality, severe depression, manic episode, and/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)

Primary outcomes:
measure: Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
Secondary outcomes:
measure: Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period.
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: Change in Physical Functioning 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 Physical Function
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: 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
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: 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
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: Change in Sleep Disturbance 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
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: 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
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8)
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: 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)
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
measure: BPI Interference Score Responder Analysis
timeFrame: Weighted average over 10 weeks, 6 months, and 12 months.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota Veteran Administration Health Care System
state: Minnesota
Study officials:
References:
citation: Burgess DJ, Evans R, Allen KD, Bangerter A, Bronfort G, Cross LJ, Ferguson JE, Haley A, Hagel Campbell EM, Mahaffey MR, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S29-S36. doi: 10.1093/pm/pnaa337.
citation: Burgess DJ, Calvert C, Hagel Campbell EM, Allen KD, Bangerter A, Behrens K, Branson M, Bronfort G, Cross LJS, Evans R, Ferguson JE, Friedman JK, Haley AC, Leininger B, Mahaffey M, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1163-1173. doi: 10.1001/jamainternmed.2024.3940.