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NCT04526158: LAMP

Learning to Apply Mindfulness to Pain

Completed NA Results posted Last updated 5 November 2024
What this trial tests

NA trial testing Mobile+Group LAMP Mindfulness-Based Intervention in Chronic Pain in 811 participants. Completed in 30 December 2023.

Timeline
2 November 2020
Primary endpoint
30 August 2023
30 December 2023

Quick facts

Lead sponsorUnited States Department of Defense
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment811
Start date2 November 2020
Primary completion30 August 2023
Estimated completion30 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

United States Department of Defense

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. Primary · Weighted average over 10 weeks, 6 months, and 12 months.

Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention4.8± 0.1
Mobile LAMP Mindfulness-Based Intervention4.5± 0.1
Usual Care5.2± 0.1
Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention4.7± 0.1
Mobile LAMP Mindfulness-Based Intervention4.6± 0.1
Usual Care5.1± 0.1
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 Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function. Minimum value: 4. Maximum value: 20. Lower scores indicate worse physical functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention13.3± 0.1
Mobile LAMP Mindfulness-Based Intervention13.3± 0.1
Usual Care12.7± 0.1
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 Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety. Minimum value: 4. Maximum value: 20. Higher scores indicate worse anxiety. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention9.2± 0.1
Mobile LAMP Mindfulness-Based Intervention8.8± 0.2
Usual Care9.4± 0.1
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 Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of fatigue. Minimum value: 4. Maximum value: 20. Higher scores indicate worse fatigue. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention12.9± 0.2
Mobile LAMP Mindfulness-Based Intervention12.7± 0.2
Usual Care13.5± 0.2
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 Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of sleep disturbance. Minimum value: 4. Maximum value: 20. Higher scores indicate worse sleep disturbance. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention13.3± 0.2
Mobile LAMP Mindfulness-Based Intervention13.3± 0.2
Usual Care13.9± 0.2
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 Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

PROMIS-29 Profile v.2.0 measure of participation in social roles and activities. Minimum value: 4. Maximum value: 20. Lower scores indicate greater participation in social roles and activities. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention12.0± 0.2
Mobile LAMP Mindfulness-Based Intervention11.9± 0.2
Usual Care11.0± 0.1
Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Patient Health Questionnaire depression scale (PHQ8). Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention8.2± 0.2
Mobile LAMP Mindfulness-Based Intervention8.2± 0.2
Usual Care9.1± 0.2
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) Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5). Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention22.8± 0.6
Mobile LAMP Mindfulness-Based Intervention22.7± 0.6
Usual Care24.9± 0.6
Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Global impression of change scale from "much better" to "much worse". Minimum value: 1. Maximum value: 7. Higher scores indicate worse outcome. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention3.4± 0.1
Mobile LAMP Mindfulness-Based Intervention3.3± 0.1
Usual Care4.1± 0.1
BPI Interference Score Responder Analysis Secondary · Weighted average over 10 weeks, 6 months, and 12 months.

Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

GroupValue95% CI
Mobile+Group LAMP Mindfulness-Based Intervention89
Mobile LAMP Mindfulness-Based Intervention109
Usual Care56

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial.
    Burgess DJ, Calvert C, Hagel Campbell EM, Allen KD, et al · · 2024 · cited 20× · PMID 39158851 · DOI 10.1001/jamainternmed.2024.3940
  2. Exploring Gender Differences in Veterans in a Secondary Analysis of a Randomized Controlled Trial of Mindfulness for Chronic Pain.
    Burgess DJ, Hagel Campbell EM, Branson M, Calvert C, et al · · 2024 · cited 5× · PMID 38404673 · DOI 10.1089/whr.2023.0086
  3. Email recruitment for chronic pain clinical trials: results from the LAMP trial.
    Ferguson JE, Hagel Campbell E, Bangerter A, Cross LJS, et al · · 2024 · cited 2× · PMID 39030622 · DOI 10.1186/s13063-024-08301-8
  4. Do mindfulness interventions cause harm? Findings from the Learning to Apply Mindfulness to Pain (LAMP) Pragmatic Clinical Trial.
    Burgess DJ, Calvert C, Bangerter A, Branson M, et al · · 2024 · cited 1× · PMID 39514882 · DOI 10.1093/pm/pnae056
  5. Optimizing diversity, equity and inclusion in pragmatic clinical trials: Findings from the Pain Management Collaboratory.
    Lovejoy TI, Midboe AM, Higgins DM, Ali J, et al · · 2025 · PMID 39505120 · DOI 10.1016/j.jpain.2024.104727

Verify or expand the search:

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other United States Department of Defense trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04526158.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing