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Original Articles

A Brief Report on an 8-Week Course of Mindfulness-based Care for Chronic Pain in the Treatment of Veterans With Back Pain

Barriers Encountered to Treatment Engagement and Lessons Learned

Eaton, Erica PhD*,†; Swearingen, Hannah R. BA; Zand Vakili, Amin MD, PhD*,†,‡; Jones, Stephanie R. PhD‡,§; Greenberg, Benjamin D. MD, PhD*,†,‡

Author Information
doi: 10.1097/MLR.0000000000001377

Abstract

Chronic back pain is a leading cause of chronic disability in veterans1 and generally.2 Findings indicate that compared with civilians, veterans experience an increase in complex pain conditions as well as elevated rates of psychiatric difficulties including posttraumatic stress disorder (PTSD), depression, and substance use disorders.3,4 They also are at greater risk for concurrent health conditions (eg, weight gain, sleep disorders, cognitive dysfunctions) and functional disability.5,6 Further, due to the risk of opioid dependence and overdose, the Veterans Affairs (VA) recommends nonpharmacological pain management and cautions against opioid pain management as supported by the Comprehensive Addiction and Recovery Act (CARA) in 2016.7 As such, there is a push to examine nonpharmacological approaches for pain.8

Complementary and integrative health (CIH) approaches are increasingly being incorporated into the Department of Veterans Affairs treatment plans and are currently a focus of VA research and implementation.9 However, there have been challenges associated with the implementation of CIH approaches within the VA Medical Centers,10 and the question remains how best to implement CIH approaches for pain management for the veteran population.

Mindfulness-based interventions (MBIs) have been applied to a wide range of symptom-based syndromes including anxiety and depression,11–14 substance use,15–17 PTSD,18–23 and chronic pain.24–26 Specifically, a central goal of mindfulness training for pain is developing nonjudgmental attention to somatic sensations, without a negative emotional charge.27 One method, mindfulness-based stress reduction (MBSR), is well-tolerated and acceptable to veterans.28 MBSR is typically delivered as a manualized 8-week program,29 focusing on increasing awareness and acceptance of moment-to-moment experiences including physical discomfort and difficult emotions.

Although measuring the experience of mindfulness and controlling for nonspecific (placebo) effects of MBIs presents challenges,30,31 randomized trials suggest they are associated with short-term improvements in physical functioning and pain intensity compared with usual care for patients with low back pain.32 However, the effects of MBSR on functioning and symptoms are generally moderate.33 A recent large randomized trial34 found 47% of participants had meaningful functional improvement after MBSR, versus 35% of individuals receiving usual care. Pain bothersomeness also improved in significantly more participants after MBSR than usual care (36% vs. 24%, respectively). More recently, Cherkin et al,35 published 2-year follow-up data concluding MBSR did not differ significantly from usual care or cognitive behavioral therapy for pain at 2 years. The authors concluded some diminution of MBSR effects relative to usual care after the 1-year mark. Further, a recent meta-analysis concluded that MBSR interventions are associated with short-term improvement in pain intensity and physical functioning compared with usual care for patients with low back pain. This effect was neither clinically meaningful nor sustained in the long term. Compared with active treatments, MBSR was not associated with any effect on pain intensity or pain-related disability.32

Recent data thus support the promise of MBIs; however, there is room for improvement in functional and symptom outcomes. Further, it is important to note facility-level barriers to implementing mindfulness-based approaches, using MBSR as an example, within the VA system of care. First, while the MBSR training program is comprehensive and highly professional, it is a time-consuming and costly process that may not be available to VA clinicians on a wide-scale. Indeed, Taylor et al,10 found that difficulties in hiring CIH providers was one of the common challenges to implementing CIH approaches within VA. Second, MBSR is traditionally taught in an 8-week course with sessions lasting 2.5 hours. There is also a half-day retreat lasting 4–6 hours and 45 minutes of homework consisting of mindfulness practice 6 days per week. This is significantly longer than the typical mental health (50–90 min) or medical appointment administered within the VA system and therefore is resource-heavy. Further, the time demands of the MBSR program also lead to patient-level barriers. It is often difficult to enroll veterans in such a time-consuming program, especially in the context of soldiers who may be integrating back into civilian life with competing demands of occupations, family, and home life. In fact, a study of community-based older adults with chronic back pain found one of the biggest barriers to participating in a program modeled after MBSR was “finding time.”36 Relatedly, Stankovic,37 identified the main reasons for dropout among a group of veterans with combat-related PTSD included schedule conflicts, full-time work, and personal stressors. As such, there is a need to develop MBIs that are useful, feasible, cost-effective, and less time-consuming within the VA system; we need interventions that lend themselves to wider implementation. Developing and pilot testing one such intervention, mindfulness-based care for chronic pain (MBCP), is the purpose of this paper.

CURRENT STUDY

In this study, we developed a new mindfulness protocol, MBCP. The attempt was to design a more pragmatic MBI for chronic pain while capturing the essence of MBSR including its core component of the cultivation of mindfulness utilizing a series of techniques including the body scan, sitting meditation, and mindful movement. We elected to adopt the 8-week course timeline but reduced the session time to 90 minutes (rather than 2.5 h). In addition, we omitted the half-day retreat. To accommodate for the reduction in time, experiential practice and instruction in class was briefer, lasting 15–20 minutes. The mindful movement included brief chair yoga stretches focused specifically on the gentle rotation of the spine and mindful walking instruction. Further, experiential exercises were geared toward awareness of difficult physical sensations whenever possible. Last, suggested readings related to managing physical pain were provided.

In addition, this study did not require MBSR trained teachers. In an effort to address the facility-level barrier of the resources needed for the MBSR training program, the study identified clinicians that were “in-house” at the VA with significant experience with MBIs and personal mindfulness practice.

METHODS

Research Design, Setting, and Participants

This project conducted an open pilot trial of MBCP for veterans. Participants attended an 8-week MBCP course, that included meditation, gentle yoga, body scans, and discussions of pain, stress, and mindful awareness. Veterans were assessed at baseline and postintervention.

Participants (N=22; mean age=49.77; 18% women) were recruited from a VA Medical Center in the Northeastern US between September 2017 and February 2018. Eligibility criteria included: (1) enrolled at the VA Medical Center; (2) chronic pain involving the lower back of at least 3-month duration; (3) at least 1 clinical (primary care, specialty pain clinic) visit where back pain was addressed within the past 15 months; (4) a rating of self-reported pain bothersomeness of at least 4 on a 0–10 scale; (5) a score of 3 or more on the pain intensity scale; and (6) be able to understand and comply with instructions. Exclusion criteria were limited to: (1) back pain possibly due to specific conditions (eg, cancer, discitis, infection, scoliosis, spinal stenosis, spondylolisthesis, pregnancy, fibromyalgia, progressive neurological deficits); (2) back pain in the context of litigation or active compensation-seeking; (3) plans for new interventions (eg, specialist or surgical care) during the study period; (4) use of a mind-body intervention for back pain currently or in the past year; (5) hearing impairment precluding the use of MBCP practice recordings; (6) active psychosis, severe personality disorder, or other unstable psychiatric disorder; (7) moderate or severe substance use disorders (aside from nicotine/caffeine). Study site institutional review boards reviewed and approved all procedures. All participants received any medical care they would normally receive.

Eligible participants were invited to enroll in MBCP and complete 2 in-person assessments: baseline and posttreatment follow-up. Participants received $50 in compensation for baseline, $10 for each MBCP class attended, and $40 for the posttreatment visit.

INTERVENTION

The MBCP manual was adapted from MBSR and modified to a group therapy format for veterans. MBCP is an 8-week group program with each session lasting 90 minutes. The manual-guided therapy comprised 4 primary components: (1) didactic content; (2) mindful movement which included chair yoga poses (breathing exercises, simple stretches, and postures designed to strengthen and relax the musculoskeletal system) and walking meditation; (3) body scans which comprise of instructions to gradually sweep one’s attention through the entire body beginning with the feet through the top of the head, and applying focus, nonjudgmentally, to any sensation or feeling in each body region; and (4) sitting meditation which involves mindful attention on the breath and a state of nonjudgmental awareness of thoughts and distractions. Experiential exercises and didactics were implemented in each session (see Appendix A for intervention components by session, Supplemental Digital Content 1, https://links.lww.com/MLR/C70). The overall goal was to be in the presence of personal suffering with a sense of safety so that the pain could be felt (rather than avoided). In addition, participants were given workbooks and daily home practice was assigned each week, which primarily included the mindful body scan with the option to substitute alternative meditations taught in class (eg, mountain meditation, lake meditation, and loving-kindness meditation). The home practice meditations were provided as guided audio meditations on MP3 players that the group members used for the duration of the 8 weeks. The group sessions were led by 2 licensed clinical psychologists both of whom have received formal MBI-training, have 10+ years of experience in MBIs with the veteran population, and have a formal personal mindfulness practice. To be considered as receiving a sufficient dose of treatment, participants had to attend 5 of the 8 sessions.

MEASURES

Demographic Information

Standard demographic questionnaire extracting sex, age, primary language, race/ethnicity, education, marital status, living situation, employment status, occupation, and degree of service-connection, self-reported by participants.

Roland Modified Disability Questionnaire (RMDQ38): Pain-related limitation was measured by the RDMQ, a 23-item measure which rates impairment over the past week (score range is 0–23; higher scores indicate greater functional limitation).

Pain Bothersomness34: Back pain bothersomeoness in the past week was measured on a 0–10 scale (0=not at all bothersome; 10 = extremely bothersome).

Pain Intensity39: Pain intensity was assessed as the mean of 3 ratings (gauged on a 0–10 scale; current, worst, and average back pain in the previous month; 10=most intense pain) derived from the Graded Chronic Pain Scale.

The Patient Health Questionnaire-9 (PHQ-940) self-administered 9-item survey assessing the severity of depressive symptoms (range, 0–24; higher scores indicate greater severity).

Chronic Pain Acceptance Questionnaire (CPAQ41): reactions to chronic pain were measured by the CPAQ, a psychometrically valid instrument. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance. The activity engagement and pain willingness factors of the CPAQ predict pain-related disability and distress.

Five Facet Mindfulness Questionnaire (FFMQ42): The experience of mindfulness was assessed using the FFMQ, a comprehensive scale that integrates conceptualizations of mindfulness. This instrument is based on a factor analytic study of 5 independently developed mindfulness questionnaires. The analysis yielded 5 factors that appear to represent elements of mindfulness as it is currently conceptualized. The 5 facets are observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience.

Therapy Continuation

As an indicator of patient acceptability and tolerance, the number of sessions attended was tracked. For the current project, we set an adequate dose of MBCP as attending 5 of the 8 sessions.

Patient Global Impression of Change (PGIC43): The PGIC is a single item self-report measure with a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). This measure depicts a patient’s rating of overall improvement.

RESULTS

Participants

Participant flow through the study is reported in Figure 1. Our recruitment strategies met proposed targets within the time frame with 62 interested veterans recruited from clinics throughout the medical center [mental health (n=4) and substance use (n=5)], self-referrals (n=22), or response to a recruitment letter sent to those veterans identified with back pain (n=30). After screening, 22 were invited to complete a baseline assessment. One participant dropped before baseline completion, and 1 was found ineligible at baseline, leaving 20 participants who were enrolled in MBCP. A total of 4 groups were run with ∼5 participants in each group. Of those screened for the study, 20 (91%) attended at least 1 session. Baseline descriptive data can be found in Table 1. Overall, the mean RMDQ score was 11.5 (SD=4.58) and pain bothersomeness rating was 6.63 (SD=1.63) indicating moderate levels of severity. At baseline, 65% of enrolled participants had at least moderate levels of depression (PHQ-9; scores ≥10).

F1
FIGURE 1:
Participant recruitment and flow. *Participants were asked to undergo fMRI scanning precompletion and postcompletion of MBCP. The results of the fMRI testing are not discussed in this manuscript; however, for the purpose of participant flow it is important to note that fMRI incompatibility was considered an exclusionary criterion, and participants were only enrolled in the study if cleared for an fMRI. **Completers of the MBCP course are considered those that participated in at least 5 MBCP classes during the course. fMRI indicates functional magnetic resonance imaging; MBCP, mindfulness-based care for chronic pain.
TABLE 1 - Patient Demographics and Baseline Characteristics (N=21)
Demographics Mean (SD)
Age 48.86 (15.20)
Sex (male) [n (%)] 17 (85)
Race [n (%)]
 White 17 (85)
 Hispanic or Latino 1 (5)
Marital status [n (%)]
 Married or living as married 8 (38.1)
 Divorced 9 (42.86)
 Single 4 (19.04)
Baseline: pain
 Intensity 6.95 (1.74)
 Bothersomeness 6.63 (1.63)
Functional limitations
 RMDQ 11.5 (4.58)
Baseline: mental health
 PHQ-9 10.95 (4.90)
Pain acceptance and mindfulness
 CPAQ 71.5 (8.21)
 FFMQ 121.65 (19.05)
Twenty-one subjects completed demographic assessments and baseline pain intensity and bothersomeness assessments.
One participant did not report pain intensity or bothersomeness high enough to meet eligibility criteria and did not complete additional baseline assessments.
Twenty completed all baseline assessments including demographics, pain intensity, and bothersomeness, RMDQ, PHQ-9, CPAQ and FFMQ.
CPAQ indicates Chronic Pain Acceptance Questionnaire; FFMQ, Five Facet Mindfulness Questionnaire; PHQ-9, Patient Health Questionnaire-9; RMDQ, Roland Modified Disability Questionnaire.

Veteran Acceptability

The first aim of this study was to assess veteran treatment engagement for the 8 sessions of MBCP. Of the 20 veterans who attended at least 1 session, the average number of sessions completed was 5 of the 8 planned sessions. Only 4 veterans (20%) attended all 8 sessions and 2 (10%) attended only 1 session. There was a pattern of greater attendance at sessions 1 through 5 compared with sessions 6 through 8 (Fig. 2). There were 11 (55%) completers, defined in this study and others15,19 as attending 5 or more sessions. Completers had an average attendance of 7 sessions and identified an average of “minimally improved” to “much improved” on the PGIC (mean=2.55). Comparisons between treatment completers and noncompleters on demographic (age, relationship status) and clinical variables (pain intensity and bothersomeness, functional disability, and depression) yielded no significant differences. There were no reported adverse events.

F2
FIGURE 2:
Attendance by session.

Clinically Meaningful Change

Eleven participants (55%) attended 5 or more sessions and had complete preintervention and postintervention data allowing for examination of clinically meaningful change (Table 2). We examined Pain Intensity and Bothersomeness, RMDQ, PHQ-9, CPAQ, and FFMQ total scores individually (Table 3) and found that 5 participants exhibited a meaningful decrease in pain intensity and 6 showed a meaningful decrease in pain bothersomeness. Participants also showed a meaningful decrease in functional impairment (n=6) and depressive symptoms (n=5). In addition, 5 participants showed an increase in chronic pain acceptance and 5 showed an increase in mindfulness. All but 2 of the group members showed a clinically significant improvement on at least one of the measures; the 2 who did not show improvement showed a clinically significant increase in pain bothersomeness. Consistent with previous behavioral therapy research, we defined meaningful change as a reduction in scores by at least 1 standard error of measurement.44

TABLE 2 - Means and SDs for Completers (N=11)
Mean (SD)
Measures Baseline Posttreatment
Pain intensity 6.45 (1.90) 5.33 (2.37)
Pain bothersomeness 7.00 (1.84) 5.55 (2.66)
RMDQ 11.73 (4.29) 9.55 (6.62)
PHQ-9 9.27 (4.17) 7.09 (5.24)
CPAQ 71.82 (8.33) 76.27 (12.27)
FFMQ 125.36 (16.00) 131.09 (19.69)
CPAQ indicates Chronic Pain Acceptance Questionnaire; FFMQ, Five Facet Mindfulness Questionnaire; PHQ-9, Patient Health Questionnaire-9; RMDQ, Roland Modified Disability Questionnaire.

TABLE 3 - Pretreatment and Posttreatment Change in Pain Intensity, Pain Bothersomeness, RMDQ, PHQ-9, CPAQ, FFMQ, and CMC
Patient # Pre/Post Change Pain Intensity (%) CMC (Y/N) Pre/Post Change Pain Bothersomeness (%) CMC (Y/N) Pre/Post Change RMDQ (%) CMC (Y/N) Pre/Post Change PHQ-9 (%) CMC (Y/N) Pre/Post Change CPAQ (%) CMC (Y/N) Pre/Post Change FFMQ (%) CMC (Y/N)
1 +83 Y 0 N +40 Y +350 Y −4 N +12 Y
2 −62 Y −43 Y −31 Y −36 Y +41 Y 0 N
3 −24 Y −40 Y −33 Y −50 Y +9 Y +13 Y
4 −10 Y −22 Y −19 Y −18 N −10 Y −1 N
5 −65 Y −71 Y −80 Y −33 N +7 Y +8 Y
6 +6 N +20 Y −100 Y −100 Y +16 Y −7 Y
7 +10 Y 0 N +20 Y +20 N +3 N +21 Y
8 +30 Y +50 Y 0 N 0 N −5 N −2 N
9 0 N +13 Y +6 N +33 Y −1 N −12 Y
10 0 N −30 Y 0 N −100 Y +4 N −1 N
11 −82 Y −83 Y −100 Y −76 Y +11 Y +21 Y
Pre/Post change directionality is identified by +/−.
The hypothesized direction for Pain Intensity, Pain Bothersomeness, RMDQ, and the PHQ is a reduction in scores (−), while the hypothesized direction for the CPAQ and FFMQ was an increase in scores (+).
CMC reflects a decrease of at least 1 standard error of measurement on Pain Intensity, Pain Bothersomeness, and the RMDQ and PHQ total scores and an increase of at least 1 standard error of measurement on the CPAQ and FFMQ.
CMC indicates clinically meaningful change; CPAQ, Chronic Pain Acceptance Questionnaire; FFMQ, Five Facet Mindfulness Questionnaire; N, no; PHQ-9, Patient Health Questionnaire-9; RMDQ, Roland Modified Disability Questionnaire; Y, yes.

DISCUSSION

Mind-body approaches to managing pain have shown promise, although they require further testing since many questions remain about the nature and durability of benefit as well as the ease of implementation in populations such as that in this naturalistic pilot study. This report documents an open-label pilot study of MBCP with 20 veterans with chronic lower back pain. We believed MBSR held promise for veterans with chronic pain and adapted the approach to fit a real-world VA setting. We encountered challenges related to engaging and retaining veterans in treatment and suggest further adaptations and refinements of MBCP or other MBIs for veterans with chronic pain are needed.

Our preliminary data, while limited, are consistent with the notion that a more pragmatic intervention, designed to be relatively easy to implement, was of interest to patients in a medium-sized VA Medical Center. Over a short recruitment period (2–4 mo), we had 62 veterans express interest in participating. However, approximately one third (n=21) did not follow through given scheduling and time constraints, despite the 4 study groups being offered at different times and days during the week to help accommodate veterans’ schedules. This is consistent with previous research identifying time and schedules as major patient-level barriers to engaging in MBIs in both community36 and veteran37 populations.

With respect to therapy continuation, attrition was high with only 11 of 20 veterans (55%) identified as completers, attending at least 5 of 8 sessions. There appeared to be a consistent decrease in attendance across sessions 1–5 and then stabilization with 45%–50% attendance at sessions 6–8. The completer rate reported herein is lower than other studies who have examined MBIs among the veteran population. For example, Kearney et al20 found that 74% of veterans attended 9–12 sessions of a 12-session loving-kindness intervention and identify completion rates (4/8 sessions) for an MBSR program for veterans with PTSD at 84%.32 Further, King et al19 reported a 75% completer rate (attendance at 5/8 sessions) for their pilot study of MBCT for veterans with PTSD. Most recently, Marchand et al,45 reported a 67% completion rate (4 or more sessions) among veterans attending an MBCT group. One hypothesis for our lower retention rate may be the local cultural attitude towards CIH approaches. The MBCP program was the first MBI-specific program offered for veterans with chronic lower back pain at the study site. We speculate that as CIH programs become more prevalent and there is an increased level of cultural acceptance of these interventions our retention rates will improve.

Lessons Learned

Despite our modifications and efforts to develop MBCP as a pragmatic and feasible intervention within the VA setting, engagement and retention of veterans was challenging. We suspect that many of the barriers we encountered in implementing MBCP may apply to difficulties in implementing MBIs with the veteran population more broadly speaking, and make the following recommendations.

First, we suggest further modifications to include a shorter duration of programs. Both the authors’ findings and those of Marchand et al,45 identified a trend in attrition after the first 4–5 sessions. These findings highlight the critical need to offer potent interventions as rapidly as possible due to the low number of sessions veterans are likely to attend. Indeed, there is some evidence to suggest that short MBIs can be effective for veterans.46–49

Second, retention may be enhanced by building in a preliminary motivational enhancement session before enrollment in MBCP. A motivational interviewing session would be designed to build rapport, assess motivation for change, provide an overview of the treatment process, and enhance motivation and commitment to participate. This may help identify and circumvent barriers to attendance and protocol adherence.

Further, we encountered, and research has identified,10 facility-level challenges to the implementation of MBIs within the VA setting related to space issues, confusion about programs being offered, and the hospital’s cultural attitude toward CIH approaches. First, we are fortunate enough to be part of a medical center that has reserved space for CIH programs in our Integrative Wellness Center. However, limited space given busy schedules for shared programming and space occupied by administrative duties did not allow for the quiet environment necessary for meditation. This may have been unappealing to some veterans. Second, CIH approaches are offered through multiple clinics throughout the hospital (eg, wellness center, mental health clinics; pain management, research, etc.). Recommendations suggest that this model can be confusing to both the patients and providers regarding what is being offered and when. Therefore, utilizing one main CIH program allows for clearer “ownership” and facilitates ease of referrals. Last, our referrals were primarily driven by recruitment letters sent to veterans with chronic back pain and not by physician or clinician referrals. Implementation research has suggested that physicians are key to patient use of CIH approaches, and therefore efforts to support staff knowledge including the scientific support for MBIs and enhancing the marketing of CIH programs to make them visible to patients, physicians, and staff10 are invaluable.

Limitations

Several limitations should be noted for this study. Our sample size was small and consisted predominately of White male veterans. In addition, to participate in this study veterans were asked to undergo functional magnetic resonance imaging (fMRI) scanning precompletion and postcompletion of MBCP. The results of the fMRI testing are not discussed in this manuscript; however, it is possible that the requirement of an fMRI was a deal-breaker for some Veterans and may have impacted enrollment or posttreatment completion rates. Future research with MBCP should include more diverse samples to examine cultural and gender differences in treatment engagement and tolerability of MBCP. Furthermore, this study lacked a qualitative measure to identify barriers to veteran engagement and retention, limiting conclusions that can be drawn regarding veteran acceptability of MBCP. Finally, given the nature of a small pilot study, the current study lacks the experimental rigor associated with a randomized controlled trial.

CONCLUSIONS AND FUTURE DIRECTIONS

Given the push to prioritize CIH research and programming within the VA setting, along with the need for nonpharmacological approaches for pain, challenges regarding the implementation of these interventions need to be further explored. Namely, formative evaluation methods to improve CIH implementation efforts are imperative and will shed light on pragmatic questions including the context to which these interventions will flourish, modifications necessary for the setting and population, and response to change. As recently suggested by Elwy et al,50 formative evaluation provides knowledge about potential and actual influences on the implantation process thereby allowing clinical research to translate into robust, effective, and meaningful veteran care.

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Keywords:

veterans; chronic back pain; mindfulness-based interventions

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