N/A
N=811
Learning to Apply Mindfulness to Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04526158 ↗Enrolled (actual)
811
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. — 4.8; 4.5; 5.2 score on a scale — p=0.031
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile+Group LAMP Mindfulness-Based Intervention (Behavioral); Mobile LAMP Mindfulness-Based Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United States Department of Defense
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. |
4.8; 4.5; 5.2 | 0.031 sig |
| SECONDARY Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. |
4.7; 4.6; 5.1 | 0.736 |
| SECONDARY 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 |
13.3; 13.3; 12.7 | 0.829 |
| SECONDARY 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 |
9.2; 8.8; 9.4 | 0.079 |
| SECONDARY 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 |
12.9; 12.7; 13.5 | 0.464 |
| SECONDARY 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 |
13.3; 13.3; 13.9 | 0.889 |
| SECONDARY 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 |
12.0; 11.9; 11.0 | 0.76 |
| SECONDARY Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) |
8.2; 8.2; 9.1 | 0.89 |
| SECONDARY 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) |
22.8; 22.7; 24.9 | 0.886 |
| SECONDARY Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period |
3.4; 3.3; 4.1 | 0.437 |
| SECONDARY BPI Interference Score Responder Analysis |
89; 109; 56 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04526158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.