Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial

Diana J Burgess; Collin Calvert; Emily M Hagel Campbell; Kelli D Allen; Ann Bangerter; Kimberly Behrens; Mariah Branson; Gert Bronfort; Lee J S Cross; Roni Evans; John E Ferguson; Jessica K Friedman; Alexander C Haley; Brent Leininger; Mallory Mahaffey; Marianne S Matthias; Laura A Meis; Melissa A Polusny; J Greg Serpa; Stephanie L Taylor; Brent C Taylor

doi:10.1001/jamainternmed.2024.3940

. 2024 Aug 19;184(10):1163–1173. doi: 10.1001/jamainternmed.2024.3940

Telehealth Mindfulness-Based Interventions for Chronic Pain

The LAMP Randomized Clinical Trial

Diana J Burgess ^1,^2,^✉, Collin Calvert ^1,², Emily M Hagel Campbell ¹, Kelli D Allen ^3,⁴, Ann Bangerter ¹, Kimberly Behrens ¹, Mariah Branson ¹, Gert Bronfort ⁵, Lee J S Cross ¹, Roni Evans ⁵, John E Ferguson ², Jessica K Friedman ⁶, Alexander C Haley ⁵, Brent Leininger ⁵, Mallory Mahaffey ¹, Marianne S Matthias ^7,^8,⁹, Laura A Meis ^1,^2,¹³, Melissa A Polusny ^1,², J Greg Serpa ^6,¹⁰, Stephanie L Taylor ^6,^11,¹², Brent C Taylor ^1,²

¹VA Health Systems Research Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota

²University of Minnesota Medical School, Minneapolis

³VA Health Systems Research Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina

⁴Thurston Arthritis Research Center, University of North Carolina at Chapel Hill

⁵Integrative Health & Wellbeing Research Program, Center for Spirituality & Healing, School of Nursing, University of Minnesota, Minneapolis

⁶VA Health Systems Research Center for the Study of Healthcare Innovation, Implementation and Policy, Greater Los Angeles VA Health Care System, Los Angeles, California

⁷VA Health Systems Research Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana

⁸Regenstrief Institute, Indianapolis, Indiana

⁹Indiana University School of Medicine, Indianapolis

¹⁰Department of Psychology, College of Life Sciences, University of California, Los Angeles

¹¹Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles

¹²Department of Health Policy and Management, Fielding School of Public Health, University of California, Los Angeles

¹³Women’s Health Sciences Division, VA National Center for Posttraumatic Stress Disorder, Boston, Massachusetts

Accepted for Publication: June 22, 2024.

Published Online: August 19, 2024. doi:10.1001/jamainternmed.2024.3940

Correction: This article was corrected on October 7, 2024, to fix 3 values in Table 2, specifically the means and standard errors in the PTSD outcome averaged over 3 time points for the group MBI, self-paced MBI, and usual care arms.

^✉

Corresponding Author: Diana J. Burgess, PhD, VA Health Systems Research Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, One Veterans Dr, Minneapolis, MN 55417 (diana.burgess@va.gov).

Author Contributions: Dr B. Taylor had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Burgess, Allen, Evans, Haley, Mahaffey, Matthias, Meis, Serpa, B. Taylor.

Acquisition, analysis, or interpretation of data: Burgess, Calvert, Hagel Campbell, Allen, Bangerter, Behrens, Branson, Bronfort, Cross, Evans, Ferguson, Friedman, Haley, Leininger, Matthias, Meis, Polusny, S. Taylor, B. Taylor.

Drafting of the manuscript: Burgess, Calvert, Hagel Campbell, Bronfort, Evans, Meis, Serpa, S. Taylor.

Critical review of the manuscript for important intellectual content: Calvert, Allen, Bangerter, Behrens, Branson, Bronfort, Cross, Evans, Ferguson, Friedman, Haley, Leininger, Mahaffey, Matthias, Meis, Polusny, Serpa, B. Taylor.

Statistical analysis: Calvert, Hagel Campbell, Bangerter, Bronfort, Friedman, Leininger, B. Taylor.

Obtained funding: Burgess, Evans, Matthias, B. Taylor.

Administrative, technical, or material support: Allen, Bangerter, Behrens, Branson, Cross, Evans, Ferguson, Haley, Mahaffey, Matthias, Meis, B. Taylor.

Supervision: Burgess, Evans, Polusny.

Conflict of Interest Disclosures: Dr Burgess reported grants from the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Nursing Research outside the submitted work. Dr Allen reported grants from the NCCIH to her institution during the conduct of the study. Dr Evans reported grants from the NCCIH and the National Institute of Nursing Research outside the submitted work. Dr Haley is a member of teaching teams at Spirit Rock Meditation Center and, as of January 2, 2024, the Director of Programs and a staff teacher at Dharma Ground, a 501(c)(3) non-profit offering meditation retreats and classes. No other disclosures were reported.

Funding/Support: The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD, 21702-5014 is the awarding and administering acquisition office. This work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration Projects under Award No. W81XWH-18-2-0003. Research reported in this publication was supported by Grant Number U24AT009769 from the NCCIH and the Office of Behavioral and Social Sciences Research (OBSSR). This material is the result of work supported with resources at the Minneapolis VA Health Care System, Durham VA Health Care System, and VA Greater Los Angeles Healthcare System. This material is a product of the Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org/. Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the Department of Defense, NCCIH, OBSSR, National Institutes of Health, US Department of Veterans Affairs, or United States Government.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Disclaimer: Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the Department of Defense, NCCIH, OBSSR, National Institutes of Health, US Department of Veterans Affairs, or the United States Government.

Additional Contributions: We express our gratitude for the continued feedback we received from our LAMP study Veteran Engagement Panel members, including Lawrence Clardy, BA; Jason Gladney, BS, MA, Geotechnical and Structures Laboratory, US Army Engineer Research and Development Center; Rose M. Glenn, JD; Rebecca A. Keller, MBA, MAOT, Mayo Clinic; Ronald Nelson, and Donna Swenson. All of these individuals were compensated for their work. Appreciation also goes to the members of our LAMP Study Advisory Panel. We thank all team members who worked on LAMP over the years especially Andrea Cutting, MA, Minneapolis VA Health Care System, Tam M. Do, MSN, RN, PHN, Minneapolis VA Health Care System, and Sierra Hennessy, BS, Flamboyan Foundation.

^✉

Corresponding author.

PMCID: PMC11334014 PMID: 39158851

Key Points

Question

How effective are scalable, relatively low-resource mindfulness-based interventions (MBIs) delivered via telehealth for veterans with chronic pain?

Findings

In this multisite randomized clinical trial, both group and self-paced MBIs improved pain-related function and biopsychosocial outcomes among veterans with chronic pain and high levels of psychiatric comorbidity. The likelihood of 30% improvement from baseline was greater for group MBI at 10 weeks and 6 months and for self-paced MBI at 10 weeks, 6 months, and 1 year.

Meaning

These scalable, relatively low-resource MBIs conducted virtually could help accelerate the implementation of nonpharmacological pain treatment in health care systems.

Abstract

Importance

Although mindfulness-based interventions (MBIs) are evidence-based treatments for chronic pain and comorbid conditions, implementing them at scale poses many challenges, such as the need for dedicated space and trained instructors.

Objective

To examine group and self-paced, scalable, telehealth MBIs, for veterans with chronic pain, compared to usual care.

Design, Setting, and Participants

This was a randomized clinical trial of veterans with moderate to severe chronic pain, recruited from 3 Veterans Affairs facilities from November 2020 to May 2022. Follow-up was completed in August 2023.

Interventions

Two 8-week telehealth MBIs (group and self-paced) were compared to usual care (control). The group MBI was done via videoconference with prerecorded mindfulness education and skill training videos by an experienced instructor, accompanied by facilitated discussions. The self-paced MBI was similar but completed asynchronously and supplemented by 3 individual facilitator calls.

Main Outcomes and Measures

The primary outcome was pain-related function using the Brief Pain Inventory interference scale at 3 time points: 10 weeks, 6 months, and 1 year. Secondary outcomes included biopsychosocial outcomes: pain intensity, physical function, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, patient ratings of improvement of pain, and posttraumatic stress disorder.

Results

Among 811 veterans randomized (mean [SD] age, 54.6 [12.9] years; 387 [47.7%] women), 694 participants (85.6%) completed the trial. Averaged across all 3 time points, pain interference scores were significantly lower for both MBIs compared to usual care (group MBI vs control difference: −0.4 [95% CI, −0.7 to −0.2]; self-paced vs control difference: −0.7 [95% CI, −1.0 to −0.4]). Additionally, both MBI arms had significantly better scores on the following secondary outcomes: pain intensity, patient global impression of change, physical function, fatigue, sleep disturbance, social roles and activities, depression, and posttraumatic stress disorder. Both group and self-paced MBIs did not significantly differ from one another. The probability of 30% improvement from baseline compared to control was greater for group MBI at 10 weeks and 6 months, and for self-paced MBI, at all 3 time points.

Conclusions and Relevance

In this randomized clinical trial, scalable telehealth MBIs improved pain-related function and biopsychosocial outcomes compared to usual care among veterans with chronic pain. Relatively low-resource telehealth-based MBIs could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems.

Trial Registration

ClinicalTrials.gov Identifier: NCT04526158

This randomized clinical trial examines the effectiveness of group and self-paced scalable, telehealth mindfulness-based interventions for veterans with chronic pain compared to usual care.

Introduction

Chronic pain, a prevalent, debilitating, and costly national problem,^1,2 disproportionately affects veterans.^3,4 Although guidelines now recommend evidence-based nonpharmacologic treatment approaches for chronic pain,^5,6 they are underused due to myriad barriers at the patient, clinician, and organization levels.^1,2,7,8,9,10 Mindfulness-based interventions (MBIs) can improve chronic pain^{5,11,12,13,14,15} and comorbid conditions, such as posttraumatic stress disorder (PTSD), sleep disorders, depression, and substance misuse,^16,17 and are now recommended as a first-line treatment.^5,18 However, many MBIs, including mindfulness-based stress reduction (MBSR), one of the most widely adopted MBIs,¹⁹ have features that pose barriers to implementation.^12,20

This pragmatic randomized clinical trial (RCT) is part of the Pain Management Collaboratory.^21,22 The study examined the effectiveness of 2 scalable telehealth approaches for delivering MBIs aimed at improving pain-related functioning and comorbid biopsychosocial conditions for veterans with chronic pain. Each MBI was adapted from MBSR, and they addressed previously identified implementation barriers at the organization level (eg, scalability) and patient level (eg, time required for sessions and practice and accessibility).^12,20

Methods

Study Design and Participants

This RCT was approved by the VA Central Institutional Review Board before data collection (see Supplement 1 for the trial protocol). Oral informed consent was obtained from all participants. This study was an RCT comparing group MBI, self-paced MBI, and usual care (control). The study design was primarily pragmatic with explanatory features for intervention delivery and follow-up.^21,23,24 A full description of the study can be found in prior publications.^25,26 Adherence to the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline was ensured. Study participants were recruited from November 2020 to May 2022 in 6 waves. Follow-up occurred from March 2021 to August 2023. Figure 1 delineates participant enrollment and follow-up.

Figure 1. — The flow diagram shows the movement of 811 participants through trial recruitment, randomization, and final data analysis.

^aPatients were randomly selected from a pool of 121 441 individuals.

Recruitment took place among patients at 3 VA Health Care Systems in Minneapolis, Minnesota; Durham, North Carolina; and Los Angeles, California. To be deemed eligible, participants must have met the following criteria: (1) two qualifying pain diagnoses in their electronic health record (EHR) within the same diagnostic category at least 90 days apart during the previous 2 years²⁷ (eTable 1 in Supplement 2), (2) a pain duration of at least 6 months, (3) pain intensity score of at least 4 during the past week on a numerical rating scale from 0 to 10,²⁸ (4) access to a smartphone and the internet, (5) willingness to engage in intervention-specific procedures (eg, meeting online for sessions), and (6) not currently enrolled in another pain study or MBSR program. We excluded patients based on medical record review indicating current psychotic symptoms, suicidality, severe depression, a manic episode, poorly controlled bipolar disorder, or indications of serious behavioral issues (eTable 2 in Supplement 2).

A gender-stratified random sample of potentially eligible VA patients was recruited from the EHR. Women, who represented 11% of veterans meeting EHR criteria, were oversampled. Patients were sent introductory materials inviting them to complete a brief screener via the study website. Patients who met initial eligibility criteria were asked to complete a baseline survey, after which study staff conducted a medical record review. Study staff then called eligible participants (prioritizing women to ensure balanced gender representation) and verified their availability, commitment, and possession of necessary technology.

Study participants were randomized to one of 3 study arms, group MBI, self-paced MBI, or usual care, in a 1:1:1 ratio. Allocation concealment methods were designed to maximize internal validity within the constraints of the study design.^29,30 The computer-generated randomization list was concealed from the research team conducting eligibility assessments and enrollment, using a centralized electronic randomization system. Outcome assessors were blinded to group assignment.

Interventions

Participants in all 3 groups continued receiving pain care as usual. The usual care (control) arm did not have access to the MBIs but was given access to self-paced MBI materials after the follow-up period was complete. Descriptions of the interventions are provided in eTable 3 in Supplement 2 using the Template for Intervention Description and Replication (TIDieR) checklist and guideline.³¹ The design of the 2 MBI arms was informed by the Behavior Change Wheel model,³² which incorporated behavioral change strategies to enhance participants’ capability, opportunity, and motivation to engage in helpful pain self-management behaviors.³² Five facilitators (4 authors, K.B., L.J.S.C., M.B., M.M., and 1 nonauthor, Sierra Hennessy) were trained to deliver the MBIs.

Group MBI Arm

The group MBI consisted of eight 90-minute weekly group sessions with between 6 and 16 participants. The sessions were delivered via secure videoconferencing and preceded by a 90-minute technical session. The program consisted of educational and instructional videos presented by a trained, certified mindfulness instructor (A.C.H) rated as advanced by the Mindfulness-Based Interventions: Teaching Assessment Criteria.³³

Content focused on providing participants with opportunities and resources to develop their mindfulness and pain self-management capabilities and motivations.³² This included mindfulness-related knowledge and skills in regulating attention and emotions, establishing body awareness, and shifting self-perceptions, considered essential content of MBIs.³³ In-session video viewing was interspersed with workbook reflections and group discussions, led by a trained facilitator. Participants were encouraged to practice on their own between sessions, using a workbook, mobile application, and study website, which included the same videos presented in the group sessions.

Self-Paced MBI Arm

The self-paced MBI consisted of eight 30- to 60-minute asynchronous weekly sessions of the same curriculum and materials as the group MBI but without group interaction. Participants received 3 phone calls from a facilitator at the beginning, middle, and end of the program (25-60 minutes each) to address technical/logistical issues and discuss progress, plans for practice, and strategies to address challenges.

Main Outcomes and Measures

Primary and secondary outcomes were assessed at baseline, 10 weeks, 6 months, and 12 months. We used modified Dillman survey procedures, described elsewhere.²⁵ Follow-up outcome assessments were conducted mostly by online surveys; if necessary, surveys were completed by postal mail.

Primary Outcome

The primary outcome, change in pain-related function over time, was assessed using the Brief Pain Inventory (BPI) interference subscale score.^34,35,36 This subscale assessed pain interference levels, ranging from 0 to 10, in the following 7 domains: general activity, mood, walking, work, relationships, sleep, and enjoyment of life. Responder analyses (reporting percentages of participants with no improvement or who were worsening, improving by 30% or more, 50% or more, and 75% or more) were assessed at all time points. Thresholds of 30% and 50% improvement from baseline were considered moderate and substantial improvement, respectively.^24,37

Secondary Outcomes

Patient-Reported Outcomes Measurement Information System 29-item profile (PROMIS-29, version 2.0) measures were used to assess physical function, anxiety, fatigue, sleep disturbance, and participation in social roles and activities.^38,39 Depression was assessed by the Patient Health Questionnaire depression scale (PHQ-8).⁴⁰ The PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (PCL-5) was used for assessing PTSD severity.⁴¹ We also assessed the following using self-report methods: pain intensity (using the BPI intensity score, which uses a 0 to 10 numeric rating scale for average pain, current pain, worst pain, and least pain with higher scores indicating worse pain), perceived change in pain (using the Pain Global Rating of Change, a single-item measure of global improvement with treatment on a 7-point scale),²⁸ adverse events, and use of additional pain treatments.⁴²

Reported participant characteristics included demographics, study site, pain diagnoses, mental and behavioral health diagnoses from the EHR, primary and secondary outcomes, and potential mediators. Race and ethnicity were assessed on the baseline survey using predefined response options to describe the sample's sociodemographic characteristics.

Statistical Analysis

Sample size was based on the ability to detect an effect size of 0.33 between groups in pain-related function over the entire 1-year follow-up period with 80% power and a 2-sided α level of .0167 to account for the 3 group comparisons.²⁵ The initial target sample size of 750 was increased to 811 to increase the number of women enrolled. Analyses were based on the intention-to-treat method for all randomized participants. All model-based analyses incorporated design factors of the gender-stratified sampling frame, survey wave, and site. For analyses of the primary outcome, we regressed BPI interference score on randomized group assignment using a linear mixed model for repeated measures with random intercepts for participants. In addition to study design factors, we adjusted for baseline values of BPI interference score and baseline pain self-efficacy, which varied among groups. Because the intraclass correlation coefficient for the group MBI was very small (0.005) and had no impact on results, it was not accounted for in the primary analysis. Between-group differences over the entire follow-up period were the primary test of treatment-group differences (for all 3 comparisons of the 3 arms). Between-group differences were estimated for each of the time points (ie, 10 weeks, 6 months, and 1 year) using a 2-way interaction between group and categorical time. Potential effect modification due to gender for the primary outcome was assessed using a 3-way interaction between gender, group, and categorical time. Secondary outcomes were similarly analyzed using linear mixed-effect models. All secondary group comparisons were exploratory and no adjustments for multiplicity were applied. Mediational and additional gender subgroup analyses will be presented in a separate report.

We addressed missing data using multiple imputation with chained equations stratified by intervention to generate 200 imputed datasets. The imputation models included all variables specified for the primary analysis and additional auxiliary variables based on results from stepwise regression hypothesis testing with a significance level of P < .10. All analyses were performed using Stata statistical software, version 18 (StataCorp LLC). Regression estimates and variances from imputed datasets were generated using the mimrgns Stata program, which combines results using Rubin rules.⁴³

Results

Study Participants

Among 811 veterans randomized (mean [SD] age, 54.6 [12.9] years; 387 [47.7%] women) (Table 1), 694 participants (85.6%) completed the trial(Figure 1). The racial and ethnic breakdown of the sample was 10 American Indian/Alaska Native (1.2%); 6 Asian American (0.7%); 204 Black or African American (25.2%); 51 (6.3%) Hispanic; 1 Native Hawaiian/Pacific Islander (0.1%); and 536 White (66.1%) participants. A total of 404 participants (49.8%) attained a bachelor’s degree or higher, and only 248 (30.6%) reported a comfortable household financial situation (Table 1). Extremity pain/arthritis was the most common diagnosis, affecting 562 participants (69.3%), followed by 387 participants (48%) with back pain. Overall, 509 participants (62.8%) had at least 1 mental illness diagnosis in the EHR (eTable 4 in Supplement 2). Baseline characteristics between the randomized groups were similar, including pain treatment use; however, pain self-efficacy scores were higher among participants in the self-paced group (Table 1).

Table 1. Baseline Sociodemographic and Pain-Related Characteristics by Randomization Arm.

Characteristic	No. (%)
Characteristic	Group	Self-paced	Usual care	Total
Participants, No.	270	271	270	811
Demographics
Gender
Man	137 (50.7)	143 (52.8)	144 (53.3)	424 (52.3)
Woman	133 (49.3)	128 (47.2)	126 (46.7)	387 (47.7)
Age, mean (SD), y	54.6 (12.9)	55.7 (13.0)	55.0 (12.2)	54.6 (12.9)
Race and ethnicity
American Indian/Alaska Native	2 (0.8)	2 (0.8)	6 (2.3)	10 (1.2)
Asian American	1 (0.4)	3 (1.1)	2 (0.8)	6 (0.8)
Black or African American	72 (27.3)	66 (24.9)	66 (25.0)	204 (25.7)
Hispanic	15 (5.6)	16 (5.9)	20 (7.4)	51 (6.3)
Native Hawaiian/Pacific Islander	1 (0.4)	0 (0.0)	0 (0.0)	1 (0.1)
White	179 (67.8)	180 (67.9)	177 (67.1)	536 (66.1%)
Multiracial	9 (3.4)	14 (5.3)	13 (4.9)	36 (4.5)
Household financial situation
Live comfortably	83 (30.7)	77 (28.4)	88 (32.6)	248 (30.6)
Meet your basic expenses with a little left over for extras	127 (47.0)	115 (42.4)	102 (37.8)	344 (42.4)
Just meet your basic expenses	53 (19.6)	68 (25.1)	68 (25.2)	189 (23.3)
Do not even have enough to meet basic expenses	7 (2.6)	11 (4.1)	12 (4.4)	30 (3.7)
Marital status
Married	139 (51.5)	134 (49.5)	155 (57.4)	428 (52.8)
Divorced/separated/widowed	73 (27.0)	81 (29.9)	71 (26.3)	225 (27.7)
Never married/single	50 (18.5)	53 (19.6)	43 (15.9)	146 (18.0)
Unknown	8 (3.0)	3 (1.1)	1 (0.4)	12 (1.5)
Employment status
Employed	118 (43.7)	106 (39.1)	109 (40.4)	333 (41.1)
Disabled	57 (21.1)	55 (20.3)	65 (24.1)	177 (21.8)
Retired	68 (25.2)	73 (26.9)	63 (23.3)	204 (25.2)
Other	27 (10.0)	37 (13.7)	33 (12.2)	97 (12.0)
Education
≤High school	21 (7.8)	16 (5.9)	16 (5.9)	53 (6.5)
Some college	119 (44.1)	116 (42.8)	119 (44.1)	354 (43.7)
Bachelor’s degree	69 (25.6)	77 (28.4)	75 (27.8)	221 (27.3)
≥Master’s degree	61 (22.6)	62 (22.9)	60 (22.2)	183 (22.6)
Rurality
Urban	167 (61.9)	158 (58.3)	173 (64.1)	498 (61.4)
Rural	87 (32.2)	96 (35.4)	82 (30.4)	265 (32.7)
Highly rural	3 (1.1)	3 (1.1)	3 (1.1)	9 (1.1)
Recruitment site
Durham, North Carolina	111 (41.1)	125 (46.1)	106 (39.3)	342 (42.2)
Minneapolis, Minnesota	116 (43.0)	104 (38.4)	125 (46.3)	345 (42.5)
Los Angeles, California	43 (15.9)	42 (15.5)	39 (14.4)	124 (15.3)
Primary and secondary outcomes
Pain functioning (BPI Pain Interference)	5.8 (1.9)	5.4 (2.0)	5.6 (1.9)	5.6 (2.0)
Pain intensity (BPI Pain Intensity)	5.6 (1.6)	5.4 (1.5)	5.6 (1.6)	5.5 (1.6)
Physical function (PROMIS)	12.3 (3.2)	12.4 (3.4)	12.3 (3.5)	12.3 (3.4)
Anxiety (PROMIS)	9.8 (3.9)	9.7 (3.8)	9.9 (4.0)	9.8 (3.9)
Fatigue (PROMIS)	13.9 (4.0)	13.6 (4.1)	13.6 (4.1)	13.7 (4.1)
Sleep disturbance (PROMIS)	14.2 (3.5)	14.0 (3.8)	14.3 (3.7)	14.2 (3.7)
Participation in social roles and activities (PROMIS)	10.0 (2.9)	10.6 (3.2)	10.4 (3.3)	10.3 (3.1)
Depression (PHQ-8)	9.8 (5.8)	9.4 (5.7)	9.5 (5.7)	9.6 (5.8)
PTSD (PCL-5)	26.8 (18.6)	27.2 (19.7)	27.8 (20.1)	27.2 (19.5)
Mediators
Pain catastrophizing (PCS)	23.5 (11.4)	21.4 (10.8)	22.3 (11.6)	22.4 (11.3)
Pain self-efficacy (PSEQ)	30.1 (11.9)	33.0 (12.7)	31.4 (11.7)	31.5 (12.1)
Perceived stress (PSFF)	31.5 (4.1)	31.4 (4.1)	31.0 (4.0)	31.3 (4.1)
Mindfulness (AMPS)	26.8 (14.2)	26.2 (13.9)	25.8 (13.7)	26.3 (13.9)

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Abbreviations: AMPS, Applied Mindfulness Process Scale; BPI, Brief Pain Inventory; PCL-5, 5-Item PTSD Checklist; PCS, Pain Catastrophizing Scale; PHQ-8, 8-Item Patient Health Questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System; PSEQ, Pain Self-Efficacy Questionnaire; PSFF, Perceived Stress Fixed Form; PTSD, posttraumatic stress disorder.

Relative to baseline, all 3 groups continued to use multiple pain treatments at similar frequencies over the 1-year follow-up. The only exceptions were the increased use of relaxation techniques and meditation/mindfulness, with much larger increases, as expected, in the 2 MBI groups (eTable 5 in Supplement 2).

Intervention Engagement

Adherence rates were 187 of 270 participants (69%) in the group MBI (defined as completing 6 or more of the 9 sessions) and 207 of 271 (76%) in the self-paced MBI (defined as completing 2 or more of the 3 facilitator calls). At 10 weeks for both MBI arms, 425 of 541 participants (78.6%) reported weekly engagement in mindful mini practices; 360 of 541 (66.5%) continued to engage in the mini practices at 12 months (eTable 6 in Supplement 2).

Primary Outcomes

No significant effect modification by gender was found for the primary outcome; thus, gender was included as a covariate in the primary model with no interaction term. Missing data imputation models included all variables specified for the primary analysis and 4 auxiliary variables significantly associated with missingness (age at index date, employment status, an indicator for any mental health diagnosis, and an indicator for an attention deficit and hyperactivity disorder diagnosis).

Averaged across the 3 follow-up time points, the group MBI arm had significantly lower BPI interference scores compared to usual care (group MBI vs usual care difference: −0.4 [95% CI, −0.7 to −0.2]; P = .002; effect size: −0.2 [95% CI, −0.4 to −0.1]). Similarly, the self-paced MBI arm had significantly lower BPI interference scores compared to usual care (self-paced vs control score difference: −0.7 [95% CI, −1.0 to −0.4]; P < .001; effect size: −0.4 [95% CI, −0.5 to −0.2]). Comparing the MBI arms with each other, no significant difference was found averaged across 3 time points, using a threshold of .0167 to adjust for multiple comparisons (group vs self-paced MBI score difference: 0.3 [95% CI, 0.0-0.6]; P = .03; effect size: 0.2 [95% CI, 0.0-0.3]) (Table 2).

Table 2. Patient-Reported Outcomes Among Group Mindfulness-Based Intervention (MBI) Arm, Self-Paced MBI Arm, or Usual Care^a.

Outcome	Mean (SE)					Difference (95% CI)
Outcome	Group MBI	Self-paced MBI		Usual care arm		Group MBI vs self-paced MBI	Group MBI vs usual care	Self-paced MBI vs usual care
Pain-related function (primary outcome)
BPI interference subscale (range, 0-10; higher score = worse)
10 wk	4.8 (0.1)	4.4 (0.1)		5.3 (0.1)		0.4 (0.1 to 0.8)	−0.5 (−0.9 to −0.2)	−1.0 (−1.3 to −0.6)
6 mo	4.7 (0.1)	4.5 (0.1)		5.2 (0.1)		0.2 (−0.2 to 0.5)	−0.5 (−0.8 to −0.1)	−0.6 (−1.0 to −0.3)
1 y	4.8 (0.1)	4.5 (0.1)		5.0 (0.1)		0.3 (−0.1 to 0.6)	−0.3 (−0.6 to 0.1)	−0.6 (−0.9 to −0.2)
Averaged over 3 time points	4.8 (0.1)	4.5 (0.1)		5.2 (0.1)		0.3 (0.0 to 0.6)	−0.4 (−0.7 to −0.2)	−0.7 (−1.0 to −0.4)
Overall P value^b	NA	NA		NA		.03	.002	<.001
Pain intensity (secondary outcome)
BPI pain intensity subscale (range, 0-10; higher score = worse)
10 wk	4.5 (0.1)	4.6 (0.1)		5.3 (0.1)		−0.0 (−0.3 to 0.3)	−0.7 (−1.0 to −0.4)	−0.7 (−1.0 to −0.4)
6 mo	4.8 (0.1)	4.7 (0.1)		5.0 (0.1)		0.1 (−0.2 to 0.4)	−0.2 (−0.5 to 0.0)	−0.4 (−0.7 to −0.1)
1 y	4.7 (0.1)	4.6 (0.1)		4.9 (0.1)		0.0 (−0.3 to 0.3)	−0.2 (−0.5 to 0.1)	−0.3 (−0.6 to 0.0)
Averaged over 3 time points	4.7 (0.1)	4.6 (0.1)		5.1 (0.1)		0.0 (−0.2 to 0.3)	−0.4 (−0.6 to −0.2)	−0.4 (−0.7 to −0.2)
Overall P value^b	NA	NA		NA		.74	<.001	<.001
Perceived change in pain (secondary outcome)
Patient Pain Global Rating of Change (range, 1-7; higher score = worse)
10 wk	3.1 (0.1)	3.2 (0.1)		4.2 (0.1)		−0.1 (−0.3 to 0.2)	−1.1 (−1.3 to −0.8)	−1.0 (−1.3 to −0.7)
6 mo	3.6 (0.1)	3.4 (0.1)		4.1 (0.1)		0.2 (−0.1 to 0.4)	−0.5 (−0.8 to −0.3)	−0.7 (−1.0 to −0.4)
1 y	3.6 (0.1)	3.4 (0.1)		4.0 (0.1)		0.2 (−0.1 to 0.4)	−0.5 (−0.8 to −0.2)	−0.7 (−0.9 to −0.4)
Averaged over 3 time points	3.4 (0.1)	3.3 (0.1)		4.1 (0.1)		0.1 (−0.1 to 0.3)	−0.7 (−0.9 to −0.5)	−0.8 (−1.0 to −0.6)
Overall P value^b	NA	NA		NA		.44	<.001	<.001
Physical function (secondary outcome)
PROMIS physical function subscale (range, 4-20; lower score = worse)
10 wk	13.3 (0.2)	13.4 (0.2)		12.5 (0.2)		−0.0 (−0.5 to 0.5)	0.8 (0.4 to 1.3)	0.9 (0.4 to 1.3)
6 mo	13.3 (0.2)	13.2 (0.2)		12.8 (0.2)		0.1 (−0.4 to 0.6)	0.5 (−0.0 to 0.9)	0.4 (−0.1 to 0.9)
1 y	13.2 (0.2)	13.4 (0.2)		12.9 (0.2)		−0.2 (−0.7 to 0.3)	0.3 (−0.2 to 0.8)	0.5 (0.0 to 1.0)
Averaged over 3 time points	13.3 (0.1)	13.3 (0.1)		12.7 (0.1)		−0.0 (−0.4 to 0.4)	0.5 (0.2 to 0.9)	0.6 (0.2 to 1.0)
Overall P value^b	NA	NA		NA		.83	.01	.004
Fatigue (secondary outcome)
PROMIS fatigue subscale (range, 4-20; higher score = worse)
10 wk	12.9 (0.2)		12.6 (0.2)		13.5 (0.2)	0.2 (−0.4 to 0.9)	−0.7 (−1.3 to −0.1)	−0.9 (−1.5 to −0.3)
6 mo	13.0 (0.2)		12.8 (0.2)		13.3 (0.2)	0.1 (−0.5 to 0.8)	−0.4 (−1.0 to 0.3)	−0.5 (−1.1 to 0.1)
1 y	12.9 (0.2)		12.6 (0.2)		13.5 (0.2)	0.2 (−0.5 to 0.9)	−0.7 (−1.3 to −0.1)	−0.9 (−1.5 to −0.3)
Averaged over 3 time points	12.9 (0.2)		12.7 (0.2)		13.5 (0.2)	0.2 (−0.3 to 0.7)	−0.6 (−1.1 to −0.1)	−0.8 (−1.3 to −0.3)
Overall P value^b	NA		NA		NA	.46	.02	.002
Sleep disturbance (secondary outcome)
PROMIS sleep disturbance subscale (range, 4-20; higher score = worse)
10 wk	13.1 (0.2)		13.2 (0.2)		14.0 (0.2)	−0.2 (−0.8 to 0.4)	−1.0 (−1.5 to −0.4)	−0.8 (−1.3 to −0.2)
6 mo	13.5 (0.2)		13.2 (0.2)		13.9 (0.2)	0.3 (−0.3 to 0.9)	−0.3 (−0.9 to 0.2)	−0.6 (−1.2 to −0.0)
1 y	13.2 (0.2)		13.3 (0.2)		13.9 (0.2)	−0.2 (−0.8 to 0.4)	−0.7 (−1.3 to −0.1)	−0.5 (−1.1 to 0.1)
Averaged over 3 time points	13.3 (0.2)		13.3 (0.2)		13.9 (0.2)	−0.0 (−0.5 to 0.4)	−0.7 (−1.1 to −0.2)	−0.6 (−1.1 to −0.2)
Overall P value^b	NA		NA		NA	.89	.004	.01
Social roles and responsibilities (secondary outcome)
PROMIS participation in social roles and activities subscale (range, 4-20; lower score = worse)
10 wk	11.9 (0.2)		11.7 (0.2)		10.7 (0.2)	0.1 (−0.4 to 0.7)	1.2 (0.7 to 1.7)	1.0 (0.5 to 1.5)
6 mo	12.1 (0.2)		11.9 (0.2)		11.2 (0.2)	0.2 (−0.4 to 0.7)	0.9 (0.4 to 1.4)	0.7 (0.2 to 1.2)
1 y	12.1 (0.2)		12.2 (0.2)		11.2 (0.2)	−0.1 (−0.7 to 0.4)	0.9 (0.4 to 1.4)	1.0 (0.5 to 1.5)
Averaged over 3 time points	12.0 (0.2)		11.9 (0.2)		11.0 (0.1)	0.1 (−0.4 to 0.5)	1.0 (0.6 to 1.4)	0.9 (0.5 to 1.3)
Overall P value^b	NA		NA		NA	.76	<.001	<.001
Depression (secondary outcome)
PHQ-8 (range, 0-24; higher score = worse)
10 wk	8.3 (0.3)		8.3 (0.3)		9.0 (0.3)	0.0 (−0.8 to 0.8)	−0.8 (−1.5 to 0.0)	−0.8 (−1.6 to −0.0)
6 mo	8.1 (0.3)		8.4 (0.3)		9.1 (0.3)	−0.3 (−1.1 to 0.5)	−1.0 (−1.8 to −0.2)	−0.7 (−1.5 to 0.1)
1 y	8.1 (0.3)		8.0 (0.3)		9.1 (0.3)	0.1 (−0.7 to 0.9)	−1.0 (−1.8 to −0.2)	−1.1 (−1.9 to −0.3)
Averaged over 3 time points	8.2 (0.2)		8.2 (0.2)		9.1 (0.2)	−0.0 (−0.7 to 0.6)	−0.9 (−1.5 to −0.3)	−0.9 (−1.5 to −0.2)
Overall P value^b	NA		NA		NA	.89	.003	.01
Anxiety (secondary outcome)
PROMIS anxiety subscale (range, 4-20; higher scores = worse)
10 wk	9.1 (0.2)		8.8 (0.2)		9.3 (0.2)	0.3 (−0.2 to 0.8)	−0.2 (−0.7 to 0.3)	−0.5 (−1.0 to 0.0)
6 mo	9.3 (0.2)		8.7 (0.2)		9.5 (0.2)	0.5 (0.0 to 1.1)	−0.2 (−0.7 to 0.3)	−0.8 (−1.3 to −0.2)
1 y	9.3 (0.2)		9.0 (0.2)		9.5 (0.2)	0.3 (−0.3 to 0.8)	−0.2 (−0.8 to 0.3)	−0.5 (−1.1 to 0.0)
Averaged over 3 time points	9.2 (0.2)		8.8 (0.2)		9.4 (0.2)	0.4 (−0.0 to 0.8)	−0.2 (−0.6 to 0.2)	−0.6 (−1.0 to −0.2)
Overall P value^b	NA		NA		NA	0.08	0.3	0.005
PTSD (secondary outcome)
PCL-5 (range, 0-80; higher score = worse)
10 wk	23.4 (0.8)		22.8 (0.8)		25.4 (0.8)	0.6 (−1.6 to 2.8)	−2.0 (−4.1 to 0.1)	−2.6 (−4.7 to −0.4)
6 mo	22.5 (0.8)		22.6 (0.8)		24.8 (0.8)	−0.1 (−2.4 to 2.1)	−2.3 (−4.4 to −0.2)	−2.2 (−4.3 to 0.0)
1 y	22.5 (0.8)		22.6 (0.8)		24.4 (0.8)	−0.0 (−2.3 to 2.3)	−1.9 (−4.1 to 0.3)	−1.8 (−4.1 to 0.4)
Averaged over 3 time points	22.8 (0.6)		22.7 (0.6)		24.9 (0.6)	0.1 (−1.6 to 1.9)	−2.0 (−3.7 to −0.4)	−2.2 (−3.9 to −0.5)
Overall P value^b	NA		NA		NA	.89	.02	.01

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Abbreviations: BPI, Brief Pain Inventory; NA, not applicable; PCL-5, 5-Item Posttraumatic Stress Disorder Checklist; PHQ-8, 8-Item Patient Health Questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System; PTSD, posttraumatic stress disorder; SE, standard error.

^{^a}

Estimates and SEs are calculated from linear mixed models with a random intercept for each participant, fit to multiply imputed datasets. Models were adjusted for participant cohort wave, Veterans Affairs recruitment site, gender, baseline pain self-efficacy score, and baseline value of the given model outcome (except for perceived change in pain, for which there was no baseline measurement).

^{^b}

The P value threshold for the primary outcome was adjusted for multiple comparisons to .0167 rather than .05. Thus, the difference between group MBI and self-paced MBI for pain interference was not statistically significant at this updated threshold.

Compared to usual care, both MBIs had significantly lower (improved) mean BPI interference scores at 10 weeks and 6 months. Participants in the self-paced MBI arm also reported lower BPI interference scores at 1 year (Figure 2).

Figure 2. — Estimates are calculated from linear mixed models with a random intercept for each participant, fit to multiply imputed datasets. Models were adjusted for participant cohort wave, Veterans Affairs recruitment site, gender, and baseline pain self-efficacy score. Models at each time point (10 weeks, 6 months, and 1 year) were adjusted for baseline mean BPI Interference score.

Responder Analyses

The probability of 30% improvement from baseline on BPI interference scores compared to control was significantly greater for the group MBI arm at 10 weeks (control: 15.9%; group MBI: 33.6%; self-paced MBI: 40.3%) and 6 months (control: 22.2%; group MBI: 34.4%; self-paced MBI: 38.2%), and at all time points for the self-paced MBI, including 1 year (control: 24.1%; group MBI: 30.3%; self-paced MBI: 42.2%). The probability of 50% improvement relative to usual care for the group MBI arm was also greater at 10 weeks (control: 6.6%; group MBI: 14.0%; self-paced MBI: 21.3%), and at all time points for the self-paced MBI, including 6 months (control: 10.4%; group MBI: 14.7%; self-paced MBI: 19.2%) and 12 months (control: 13.3%; group MBI: 16.6%; self-paced MBI: 20.8%) (Table 3).

Table 3. Probability Estimates for Changes in the Primary Outcome by Mindfulness-Based Intervention (MBI) Arm and Usual Care at Follow-Up Time Points^a.

Pain interference reduction	Improvement probability, %			Probability difference (95% CI), pp
Pain interference reduction	Group MBI	Self-paced MBI	Usual care	Group MBI minus self-paced MBI	Group MBI minus usual care	Self-paced MBI minus usual care
10 wk
No reduction or worsening	33.8^b	30.7^b	43.7	3.2 (−5.2 to 11.5)	−9.8 (−18.1 to −1.6)	−13.0 (−21.3 to −4.7)
≥30%	33.6^b	40.3^b	15.9	−6.7 (−15.4 to 1.9)	17.6 (10.2 to 25.0)	24.4 (16.6 to 32.1)
≥50%	14.0^b	21.3^b^,^c	6.6	−7.3 (−14.2 to −0.5)	7.4 (2.1 to 12.7)	14.7 (8.6 to 20.8)
≥75%	2.2	7.1^b^,^c	1.7	−5.0 (−8.9 to −1.0)	0.5 (−2.1 to 3.0)	5.4 (1.6 to 9.2)
6 mo
No reduction or worsening	32.7	30^b	41.7	2.7 (−5.6 to 11.0)	−9.0 (−17.4 to −0.1)	−11.7 (−20.1 to −3.4)
≥30%	34.4^b	38.2^b	22.2	−3.8 (−12.5 to 4.8)	12.2 (4.3 to 20.1)	16.0 (7.8 to 24.2)
≥50%	14.7	19.2^b	10.4	−4.5 (−11.4 to 2.4)	4.2 (−1.8 to 10.2)	8.7 (2.3 to 15.2)
≥75%	4.0	6.6^a	2.2	−2.6 (−6.9 to 1.7)	1.8 (−1.6 to 5.1)	4.4 (0.5 to 8.2)
1 y
No reduction or worsening	33.5	29.2	37.4	4.2 (−4.0 to 12.4)	−4.0 (−12.3 to 4.3)	−8.2 (−16.4 to 0.0)
≥30%	30.3^b	42.2^b^,^c	24.1	−12.0 (−20.5 to −3.4)	6.2 (−1.7 to 14.0)	18.1 (9.9 to 26.3)
≥50%	16.6	20.8^b	13.3	−4.2 (−11.2 to 2.8)	3.3 (−3.0 to 9.6)	7.5 (0.9 to 14.1)
≥75%	7.6	7.9	4.7	−0.3 (−5.1 to 4.6)	2.9 (−1.5 to 7.3)	3.2 (−1.1 to 7.5)

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Abbreviation: pp, percentage point.

^{^a}

Estimates and 95% CIs are calculated from generalized linear mixed models with a random intercept for each participant, fit to multiply imputed datasets. The model was adjusted for participant cohort wave, Veterans Affairs recruitment site, gender, baseline pain self-efficacy score, and baseline pain interference score.

^{^b}

Signifies an estimate in either the group MBI or self-paced MBI arm that is statistically significantly different from the estimate in the usual care arm at a significance level of P < .05 within the same follow-up time point.

^{^c}

Signifies an estimate in the self-paced MBI arm that is statistically significantly different from the estimate in the group MBI arm at a significance level of P < .05 within the same follow-up time point.

Secondary Outcomes

Both MBIs had significantly better scores compared to usual care for almost all secondary outcomes (pain intensity, physical function, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, perceived change in pain, and PTSD). Differences between group MBI and self-paced MBI arms were not statistically significant.

Adverse Events

No serious adverse events were reported in any of the 3 arms. At 10 weeks, 63 of 237 participants in the group arm (27%) and 49 of 215 participants in the self-paced arm (23%) reported an increase in psychological or physical symptoms on the 10-week assessment compared to 130 of 245 participants (53%) in the usual care arm (eTable 7 in Supplement 2).⁴⁴

Discussion

In this multisite pragmatic RCT of scalable MBIs for chronic pain, both group and self-paced MBIs significantly improved pain functioning (the primary outcome) and biopsychosocial outcomes among veterans with chronic pain compared to usual care during the 1-year study. However, mean group differences for the primary outcome were small. The group and self-paced MBIs performed similarly. Several factors beyond the magnitude of group differences should be considered when interpreting the clinical importance of these findings. This includes consideration of the broader context of the condition studied, consistency between primary and secondary outcomes, results of responder analyses, durability of treatment effect over time, overall risk-benefit ratios, and access to treatment.³⁷ Responder analyses are most appropriate for assessing clinically important changes at the individual patient level.³⁷ In this RCT, the advantages of MBIs over usual care were sustained during the 1-year study, consistent across outcomes, and similar to other guideline-recommended chronic pain treatments including MBSR.^11,30 These findings are noteworthy given the high levels of psychiatric comorbidities in the trial population. Further, significantly more participants in both MBIs reported 30% and 50% improvement in pain-related function at 10 weeks, considered moderate and substantial improvement, respectively.^24,37 This effect was sustained for the self-paced MBI at 1 year. Engagement with the MBIs was high, and they were safely administered, with fewer physical and mental health symptoms reported relative to usual care, suggesting the MBIs may have protective effects.⁴⁴ Overall, we consider the advantage of both scalable, low-resource MBIs (group and self-paced) compared to usual care clinically important.

The similar performance of the self-paced and group MBIs is somewhat surprising given the importance placed on group social support in other MBIs.^45,46 Veterans in the self-paced arm did, however, receive 3 calls from a facilitator, providing individualized social support, problem-solving, and other behavior change techniques to encourage and support their engagement. Individualization is important to patients and an important aspect of building effective therapeutic alliances, especially in trauma-informed care.^47,48 More individualized support may account for some of the performance of the self-paced MBI, in addition to the flexibility of participating in facilitator calls and engaging with mindfulness content at times convenient for the individual.

Strengths and Limitations

This RCT had several strengths that addressed existing gaps in the MBI and pain self-management literature.³³ This includes clear articulation of intervention elements using the TIDieR checklist,³¹ application of robust behavioral models,^31,33 larger sample sizes,⁴⁹ a focus on veterans,⁵⁰ a large sample of women veterans, and socioeconomically disadvantaged participants.⁴⁹ The trial had many pragmatic design features (a focus of the Pain Management Collaboratory),^21,22 aimed at facilitating future implementation. This includes recruitment from a real-world setting with broad inclusion and narrow exclusion criteria, resulting in a sample of patients with heterogeneous chronic pain conditions and high levels of psychiatric comorbidities receiving pain care at VA health centers. The MBIs were intentionally designed to meet the needs of veterans and the VA health system by addressing barriers to delivering and participating in more intensive MBIs. In addition to being shorter, the MBIs did not require certified mindfulness instructors, providing additional benefits of systematic content delivery (enhancing fidelity) and availability of content for veterans to review between sessions.

One limitation of this trial is that it was not designed to answer questions of how less resource-intensive MBIs perform compared to more intensive MBSR programs, or how remotely delivered programs compared to in-person MBIs. However, the magnitude of group differences between MBIs and usual care is similar to what has been observed in another high-quality study of in-person MBSR for pain conditions using 2-hour sessions and an optional retreat.¹⁴ Our study also did not address cost-effectiveness. Furthermore, this trial was not designed to control for time, attention, and other contextual factors because of its pragmatic design; patient expectations were also not measured. Therefore, nonspecific aspects of the MBIs may have contributed to improvement in outcomes.^49,51 Qualitative results exploring veterans’ perceptions of the MBIs will provide additional insight into contextual factors and will be addressed in a separate publication. Blinding participants and facilitators to the interventions was also not possible. Roughly half of participants in the usual care arm also used meditation/mindfulness throughout the study; to what extent this may have reduced the advantage of MBI over usual care is unknown. Because many participants used concomitant treatment for their chronic pain, independent MBI performance is unknown; however, multimodal treatment is the standard of care for chronic pain management, and MBIs are typically used as adjunct interventions. Additionally, approximately 81% of veterans did not respond or declined to participate in the study in response to the initial recruitment material, which may affect the generalizability of these findings.

Conclusions

Two relatively low-resource, scalable MBIs (offered in group or self-paced formats), improved pain-related function and other biopsychosocial outcomes over 1 year compared to usual care among veterans with chronic pain and a high level of psychiatric comorbidities. The viability and similarity of both these approaches for delivering MBIs increase patient options for meeting their individual needs and could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems.

Supplement 1.

Trial Protocol

jamainternmed-e243940-s001.pdf^{(814.4KB, pdf)}

Supplement 2.

eTable 1. Pain Categories

eTable 2. Operational Definition for Exclusion Based on Chart Review

eTable 3. Intervention Description (based on Template for Intervention Description and Replication (TIDieR)1

eTable 4. Baseline Mental Health Diagnoses, Pain Diagnoses, and Prior Pain Treatment in the Past 3 Months by Randomization Group

eTable 5. Prior Pain Treatment at 10 weeks, 6 months and 12 months by Treatment Arm

eTable 6. Completion of Intervention Activities in a Typical Week, at 10 Weeks, 6 Months, and 12 Months by MBI Group

eTable 7. Side Effect Probabilities (and CIs) by Intervention Arm

jamainternmed-e243940-s002.pdf^{(426KB, pdf)}

Supplement 3.

Data Sharing Statement

jamainternmed-e243940-s003.pdf^{(16.1KB, pdf)}

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23.Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. doi: 10.1136/bmj.h2147 [DOI] [PubMed] [Google Scholar]
24.Smith SM, Dworkin RH, Turk DC, et al. Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations. Pain. 2020;161(11):2446-2461. doi: 10.1097/j.pain.0000000000001952 [DOI] [PMC free article] [PubMed] [Google Scholar]
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26.Burgess DJ, Hagel Campbell EM, Branson M, et al. Exploring gender differences in veterans in a secondary analysis of a randomized controlled trial of mindfulness for chronic pain. Womens Health Rep (New Rochelle). 2024;5(1):82-92. doi: 10.1089/whr.2023.0086 [DOI] [PMC free article] [PubMed] [Google Scholar]
27.Goulet JL, Kerns RD, Bair M, et al. The musculoskeletal diagnosis cohort: examining pain and pain care among veterans. Pain. 2016;157(8):1696-1703. doi: 10.1097/j.pain.0000000000000567 [DOI] [PMC free article] [PubMed] [Google Scholar]
28.Krebs EE, Carey TS, Weinberger M. Accuracy of the pain numeric rating scale as a screening test in primary care. J Gen Intern Med. 2007;22(10):1453-1458. doi: 10.1007/s11606-007-0321-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
29.Clark L, Fairhurst C, Torgerson DJ. Allocation concealment in randomised controlled trials: are we getting better. BMJ. 2016;355:i5663. doi: 10.1136/bmj.i5663 [DOI] [PubMed] [Google Scholar]
30.Savović J, Jones HE, Altman DG, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157(6):429-438. doi: 10.7326/0003-4819-157-6-201209180-00537 [DOI] [PubMed] [Google Scholar]
31.Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687 [DOI] [PubMed] [Google Scholar]
32.Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81-95. doi: 10.1007/s12160-013-9486-6 [DOI] [PubMed] [Google Scholar]
33.Crane RS, Hecht FM. Intervention integrity in mindfulness-based research. Mindfulness (N Y). 2018;9(5):1370-1380. doi: 10.1007/s12671-018-0886-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
34.Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994;23(2):129-138. [PubMed] [Google Scholar]
35.Kean J, Monahan PO, Kroenke K, et al. Comparative responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016;54(4):414-421. doi: 10.1097/MLR.0000000000000497 [DOI] [PMC free article] [PubMed] [Google Scholar]
36.Chen CX, Kroenke K, Stump T, et al. Comparative responsiveness of the PROMIS pain interference short forms with legacy pain measures: results from three randomized clinical trials. J Pain. 2019;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010 [DOI] [PMC free article] [PubMed] [Google Scholar]
37.Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146(3):238-244. doi: 10.1016/j.pain.2009.08.019 [DOI] [PubMed] [Google Scholar]
38.Cook KF, Jensen SE, Schalet BD, et al. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol. 2016;73:89-102. doi: 10.1016/j.jclinepi.2015.08.038 [DOI] [PMC free article] [PubMed] [Google Scholar]
39.Deyo RA, Ramsey K, Buckley DI, et al. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) short form in older adults with chronic musculoskeletal pain. Pain Med. 2016;17(2):314-324. [DOI] [PMC free article] [PubMed] [Google Scholar]
40.Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163-173. doi: 10.1016/j.jad.2008.06.026 [DOI] [PubMed] [Google Scholar]
41.Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016;28(11):1379-1391. doi: 10.1037/pas0000254 [DOI] [PubMed] [Google Scholar]
42.Pain Management Collaboratory . Nonpharmacological and self-care approaches measure from PMC (NSCAP). Accessed March 14, 2023. https://painmanagementcollaboratory.org/nonpharmacological-and-self-care-approaches/
43.Klein D. MIMRGNS: Stata module to run margins after mi estimate. Ideas. 2022. https://ideas.repec.org/c/boc/bocode/s457795.html
44.Burgess D, Calvert C, Bangerter A, et al. Do Mindfulness interventions cause harm: findings from the learning to apply mindfulness to pain study. J Pain. 2023;24(4):63. doi: 10.1016/j.jpain.2023.02.187 [DOI] [Google Scholar]
45.Santorelli SF, Meleo-Meyer F, Koerbel L. Mindfulness-Based Stress Reduction (MBSR). Authorized Curriculum Guide; 2017. [Google Scholar]
46.Allexandre D, Bernstein AM, Walker E, Hunter J, Roizen MF, Morledge TJ. A web-based mindfulness stress management program in a corporate call center: a randomized clinical trial to evaluate the added benefit of onsite group support. J Occup Environ Med. 2016;58(3):254-264. doi: 10.1097/JOM.0000000000000680 [DOI] [PMC free article] [PubMed] [Google Scholar]
47.O’Keeffe M, Cullinane P, Hurley J, et al. What Influences patient-therapist interactions in musculoskeletal physical therapy: qualitative systematic review and meta-synthesis. Phys Ther. 2016;96(5):609-622. doi: 10.2522/ptj.20150240 [DOI] [PubMed] [Google Scholar]
48.Krause DJ, Green SA, Koury SP, Hales TW. Solution-focused trauma-informed care (SF-TIC): an integration of models. J Public Child Welf. 2018;12(2):117-135. doi: 10.1080/15548732.2017.1348312 [DOI] [Google Scholar]
49.Goldberg SB, Riordan KM, Sun S, Davidson RJ. The Empirical status of mindfulness-based interventions: a systematic review of 44 meta-analyses of randomized controlled trials. Perspect Psychol Sci. 2022;17(1):108-130. doi: 10.1177/1745691620968771 [DOI] [PMC free article] [PubMed] [Google Scholar]
50.Marchand WR, Sandoval K, Lackner R, et al. Mindfulness-based interventions for military veterans: A systematic review and analysis of the literature. Complement Ther Clin Pract. 2021;42:101274. doi: 10.1016/j.ctcp.2020.101274 [DOI] [PubMed] [Google Scholar]
51.Sharpe L, Richmond B, Menzies RE, Forrest D, Crombez G, Colagiuri B. A synthesis of meta-analyses of mindfulness-based interventions in pain. Pain. 2024;165(1):18-28. doi: 10.1097/j.pain.0000000000002997 [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial Protocol

jamainternmed-e243940-s001.pdf^{(814.4KB, pdf)}

Supplement 2.

eTable 1. Pain Categories

eTable 2. Operational Definition for Exclusion Based on Chart Review

eTable 3. Intervention Description (based on Template for Intervention Description and Replication (TIDieR)1

eTable 4. Baseline Mental Health Diagnoses, Pain Diagnoses, and Prior Pain Treatment in the Past 3 Months by Randomization Group

eTable 5. Prior Pain Treatment at 10 weeks, 6 months and 12 months by Treatment Arm

eTable 6. Completion of Intervention Activities in a Typical Week, at 10 Weeks, 6 Months, and 12 Months by MBI Group

eTable 7. Side Effect Probabilities (and CIs) by Intervention Arm

jamainternmed-e243940-s002.pdf^{(426KB, pdf)}

Supplement 3.

Data Sharing Statement

jamainternmed-e243940-s003.pdf^{(16.1KB, pdf)}

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[ioi240049r35] 35.Kean J, Monahan PO, Kroenke K, et al. Comparative responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016;54(4):414-421. doi: 10.1097/MLR.0000000000000497 [DOI] [PMC free article] [PubMed] [Google Scholar]

[ioi240049r36] 36.Chen CX, Kroenke K, Stump T, et al. Comparative responsiveness of the PROMIS pain interference short forms with legacy pain measures: results from three randomized clinical trials. J Pain. 2019;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010 [DOI] [PMC free article] [PubMed] [Google Scholar]

[ioi240049r37] 37.Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146(3):238-244. doi: 10.1016/j.pain.2009.08.019 [DOI] [PubMed] [Google Scholar]

[ioi240049r38] 38.Cook KF, Jensen SE, Schalet BD, et al. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol. 2016;73:89-102. doi: 10.1016/j.jclinepi.2015.08.038 [DOI] [PMC free article] [PubMed] [Google Scholar]

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[ioi240049r40] 40.Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163-173. doi: 10.1016/j.jad.2008.06.026 [DOI] [PubMed] [Google Scholar]

[ioi240049r41] 41.Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016;28(11):1379-1391. doi: 10.1037/pas0000254 [DOI] [PubMed] [Google Scholar]

[ioi240049r42] 42.Pain Management Collaboratory . Nonpharmacological and self-care approaches measure from PMC (NSCAP). Accessed March 14, 2023. https://painmanagementcollaboratory.org/nonpharmacological-and-self-care-approaches/

[ioi240049r43] 43.Klein D. MIMRGNS: Stata module to run margins after mi estimate. Ideas. 2022. https://ideas.repec.org/c/boc/bocode/s457795.html

[ioi240049r44] 44.Burgess D, Calvert C, Bangerter A, et al. Do Mindfulness interventions cause harm: findings from the learning to apply mindfulness to pain study. J Pain. 2023;24(4):63. doi: 10.1016/j.jpain.2023.02.187 [DOI] [Google Scholar]

[ioi240049r45] 45.Santorelli SF, Meleo-Meyer F, Koerbel L. Mindfulness-Based Stress Reduction (MBSR). Authorized Curriculum Guide; 2017. [Google Scholar]

[ioi240049r46] 46.Allexandre D, Bernstein AM, Walker E, Hunter J, Roizen MF, Morledge TJ. A web-based mindfulness stress management program in a corporate call center: a randomized clinical trial to evaluate the added benefit of onsite group support. J Occup Environ Med. 2016;58(3):254-264. doi: 10.1097/JOM.0000000000000680 [DOI] [PMC free article] [PubMed] [Google Scholar]

[ioi240049r47] 47.O’Keeffe M, Cullinane P, Hurley J, et al. What Influences patient-therapist interactions in musculoskeletal physical therapy: qualitative systematic review and meta-synthesis. Phys Ther. 2016;96(5):609-622. doi: 10.2522/ptj.20150240 [DOI] [PubMed] [Google Scholar]

[ioi240049r48] 48.Krause DJ, Green SA, Koury SP, Hales TW. Solution-focused trauma-informed care (SF-TIC): an integration of models. J Public Child Welf. 2018;12(2):117-135. doi: 10.1080/15548732.2017.1348312 [DOI] [Google Scholar]

[ioi240049r49] 49.Goldberg SB, Riordan KM, Sun S, Davidson RJ. The Empirical status of mindfulness-based interventions: a systematic review of 44 meta-analyses of randomized controlled trials. Perspect Psychol Sci. 2022;17(1):108-130. doi: 10.1177/1745691620968771 [DOI] [PMC free article] [PubMed] [Google Scholar]

[ioi240049r50] 50.Marchand WR, Sandoval K, Lackner R, et al. Mindfulness-based interventions for military veterans: A systematic review and analysis of the literature. Complement Ther Clin Pract. 2021;42:101274. doi: 10.1016/j.ctcp.2020.101274 [DOI] [PubMed] [Google Scholar]

[ioi240049r51] 51.Sharpe L, Richmond B, Menzies RE, Forrest D, Crombez G, Colagiuri B. A synthesis of meta-analyses of mindfulness-based interventions in pain. Pain. 2024;165(1):18-28. doi: 10.1097/j.pain.0000000000002997 [DOI] [PubMed] [Google Scholar]

PERMALINK

Telehealth Mindfulness-Based Interventions for Chronic Pain

Diana J Burgess, PhD

Collin Calvert, PhD

Emily M Hagel Campbell, MS

Kelli D Allen, PhD

Ann Bangerter, BS

Kimberly Behrens, MS

Mariah Branson, BA

Gert Bronfort, PhD

Lee J S Cross, MPH

Roni Evans, PhD

John E Ferguson, PhD

Jessica K Friedman, PhD

Alexander C Haley, PhD

Brent Leininger, PhD

Mallory Mahaffey, MPH

Marianne S Matthias, PhD

Laura A Meis, PhD

Melissa A Polusny, PhD

J Greg Serpa, PhD

Stephanie L Taylor, PhD

Brent C Taylor, PhD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objective

Design, Setting, and Participants

Interventions

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Study Design and Participants

Figure 1. CONSORT Flow Diagram.

Interventions

Group MBI Arm

Self-Paced MBI Arm

Main Outcomes and Measures

Primary Outcome

Secondary Outcomes

Statistical Analysis

Results

Study Participants

Table 1. Baseline Sociodemographic and Pain-Related Characteristics by Randomization Arm.

Intervention Engagement

Primary Outcomes

Table 2. Patient-Reported Outcomes Among Group Mindfulness-Based Intervention (MBI) Arm, Self-Paced MBI Arm, or Usual Carea.

Figure 2. Mean Brief Pain Inventory (BPI) Interference Score by Mindfulness-Based Intervention (MBI) Arm vs Usual Care.

Responder Analyses

Table 3. Probability Estimates for Changes in the Primary Outcome by Mindfulness-Based Intervention (MBI) Arm and Usual Care at Follow-Up Time Pointsa.

Secondary Outcomes

Adverse Events

Discussion

Strengths and Limitations

Conclusions

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

Similar articles

Cited by other articles

Links to NCBI Databases

Table 2. Patient-Reported Outcomes Among Group Mindfulness-Based Intervention (MBI) Arm, Self-Paced MBI Arm, or Usual Care^a.

Table 3. Probability Estimates for Changes in the Primary Outcome by Mindfulness-Based Intervention (MBI) Arm and Usual Care at Follow-Up Time Points^a.