Learning to Apply Mindfulness to Pain

Study Overview
=================
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.

Official Title
-----------------
Testing Two Scalable, Veteran-centric Mindfulness-based Interventions for Chronic Musculoskeletal Pain: A Pragmatic, Multisite Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention
* Behavioral: Mobile LAMP Mindfulness-Based Intervention


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm parallel assignment design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile+Group LAMP Mindfulness-Based Intervention<br>8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook. | Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention<br>* The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. 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 a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.<br>* Other names: Mobile+Group LAMP;|
| Experimental: Mobile LAMP Mindfulness-Based Intervention<br>8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program. | Behavioral: Mobile LAMP Mindfulness-Based Intervention<br>* The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. 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 (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.<br>* Other names: Mobile LAMP;|
| No Intervention: Usual Care<br>Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Brief Pain Inventory (BPI) intensity score from baseline, over the 12-month follow-up period. | Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. | Assessed at baseline, 10 weeks, 6 months, and 12 months, to capture short-term, mid-term, and long-term effects | 
| 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 | Minimum value: 1. Maximum value: 5. Lower scores indicate worse physical functioning | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| 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 | Minimum value: 1. Maximum value: 5. Higher scores indicate worse anxiety | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| 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 | Minimum value: 1. Maximum value:5. Higher scores indicate worse fatigue | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| 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 | Minimum value: 1. Maximum value: 5. Higher scores indicate worse sleep disturbance | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| 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 | Minimum value: 1. Maximum value: 5. Lower scores indicate greater participation in social roles and activities | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| Change in depression over the 12-month follow-up period assessed by score on the eight-item Patient Health Questionnaire depression scale (PHQ8) | Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| 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) | Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD | Assessed at baseline, 10 weeks, 6 months, and 12 months | 
| Mean global improvement of pain score, over the 12-month follow-up period | Global impression of change scale from much better to much worse | Assessed at 10 weeks, 6 months, and 12 months | 
| BPI Interference Score Responder Analysis | Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score to capture short-term, mid-term, and long-term effects. | Assessed at 10 weeks, 6 months, and 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Veteran, Chronic pain