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Randomized Controlled Trial of Mindfulness-Oriented Recovery Enhancement for Chronic Pain and Prescription Opioid Misuse: Clinical Outcomes and Mechanisms

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PURPOSE: Opioid analgesic pharmacotherapy is a common treatment for chronic pain. Yet, for a subset of patients, chronic opioid use and the use of opioids to self-medicate negative emotions that co-occur with chronic pain may confer risk for opioid misuse and addiction. Prescription opioid misuse among persons with chronic pain is a prevalent threat to public health that has increased more than threefold over the past 20 years. This NIH-funded randomized controlled trial sought to determine whether an integrative, multimodal intervention, Mindfulness-Oriented Recovery Enhancement (MORE), could reduce chronic pain and opioid misuse. We hypothesized that MORE would reduce pain severity, pain-related functional impairment, opioid craving, and opioid misuse to a significantly greater extent than a conventional support group (SG). METHODS: Chronic pain patients (N = 115) were randomized to either a MSW-led MORE group (n = 57) or a SG (n = 58). The MORE intervention sessions involved mindfulness training, cognitive restructuring, and techniques for positive emotion regulation (i.e., finding meaning in adversity, savoring pleasant events). Standardized measures of pain severity, pain-related functional interference, opioid craving, and opioid misuse were collected pre- and post-intervention, as well as at 3-month follow-up. To explore therapeutic mechanisms, measures of reinterpretation of pain sensations, nonreactivity, positive reappraisal, and heart rate variability (HRV) to pain-, opioid-, and pleasure-related visual stimuli were monitored pre- and post-treatment. RESULTS: The MORE group demonstrated significantly greater decreases in pain severity (p = .04), functional interference (p < .001), and opioid craving (p = .005) than the SG; effects on pain severity and interference persisted for 3 months. Compared to the SG, a greater proportion of individuals in the MORE group who met criteria for opioid misuse at pre-treatment no longer met opioid misuse criteria at post-treatment (p = .05). Increases in reinterpretation of pain sensations, nonreactivity, and positive reappraisal were associated with decreases in pain severity, functional interference, and opioid craving/misuse, respectively. HRV responses were associated with reduced opioid craving and misuse. IMPLICATIONS FOR PRACTICE: By virtue of its effects on cognitive, affective, and psychophysiological mechanisms, MORE appears to ameliorate chronic pain and opioid-related problems. Importantly, significant intervention effects on chronic pain may persist up to 3 months after completing treatment. Thus, MORE appears to be a promising means of enhancing therapeutic outcomes among vulnerable persons suffering from chronic pain and addictive behaviors.
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Mindfulness-Oriented Recovery Enhancement for Chronic Pain and Prescription
Opioid Misuse: Results From an Early-Stage Randomized Controlled Trial
Eric L. Garland
University of Utah
Eron G. Manusov
Duke Southern Regional Area Health Education Center,
Fayetteville, North Carolina
Brett Froeliger
Medical University of South Carolina
Amber Kelly
Smith College
Jaclyn M. Williams
Florida State University
Matthew O. Howard
University of North Carolina at Chapel Hill
Objective: Opioid pharmacotherapy is now the leading treatment for chronic pain, a problem that affects
nearly one third of the U.S. population. Given the dramatic rise in prescription opioid misuse and opioid-
related mortality, novel behavioral interventions are needed. The purpose of this study was to conduct an
early-stage randomized controlled trial of Mindfulness-Oriented Recovery Enhancement (MORE), a multi-
modal intervention designed to simultaneously target mechanisms underpinning chronic pain and opioid
misuse. Method: Chronic pain patients (N115; mean age 48 14 years; 68% female) were randomized
to 8 weeks of MORE or a support group (SG). Outcomes were measured at pre- and posttreatment, and at
3-month follow-up. The Brief Pain Inventory was used to assess changes in pain severity and interference.
Changes in opioid use disorder status were measured by the Current Opioid Misuse Measure. Desire for
opioids, stress, nonreactivity, reinterpretation of pain sensations, and reappraisal were also evaluated. Results:
MORE participants reported significantly greater reductions in pain severity (p.038) and interference (p
.003) than SG participants, which were maintained by 3-month follow-up and mediated by increased
nonreactivity and reinterpretation of pain sensations. Compared with SG participants, participants in MORE
evidenced significantly less stress arousal (p.034) and desire for opioids (p.027), and were significantly
more likely to no longer meet criteria for opioid use disorder immediately following treatment (p.05);
however, these effects were not sustained at follow-up. Conclusions: Findings demonstrate preliminary
feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain.
Keywords: addiction, chronic pain, mindfulness, opioid, cognitive reappraisal
Prescription opioid misuse is an emerging public health concern
with significant health and psychological risks. Though opioid
analgesic therapy for chronic pain is often efficacious, and most
patients take medicine as prescribed, some individuals exhibit
addictive tendencies toward opioids (Fishbain, Cole, Lewis, Ro-
somoff, & Rosomoff, 2008). Opioid addiction among chronic pain
patients involves cognitive, affective, and behavioral dysregulation
that, when coupled with persistent or worsening pain, may result in
significant functional impairment and suffering (Højsted, Nielsen,
Guldstrand, Frich, & Sjøgren, 2010). Opioid addiction may be
presaged by the occurrence of opioid misuse behaviors, such as
dose escalation or use of prescribed opioids to self-medicate neg-
ative emotions and stress (Butler et al., 2007); these medication-
misusing behaviors are common, with more than one in 10 chronic
pain patients exhibiting signs of opioid misuse (Fishbain et al.,
2007). Although opioid agents with lower addiction liability like
buprenorphine can effectively substitute for unauthorized opioid
use (Ling et al., 1998), extant treatments for opioid addiction are
typically ineffective in the absence of ongoing maintenance phar-
macotherapy (Weiss et al., 2011). Further, persons seeking treat-
ment for chronic pain respond especially poorly to motivational
and behavioral addiction treatments (Larson et al., 2007). Current
best practices for persons with chronic pain who are at risk for
prescription opioid misuse and addiction (e.g., Jamison, Serraillier,
& Michna, 2011; Oliver et al., 2012) include frequent opioid
Eric L. Garland, College of Social Work and Huntsman Cancer Institute,
University of Utah; Eron G. Manusov, Duke Southern Regional Area
Health Education Center, Fayetteville, North Carolina; Brett Froeliger,
Department of Neuroscience and Hollings Cancer Center, Medical Uni-
versity of South Carolina; Amber Kelly, School of Social Work, Smith
College; Jaclyn M. Williams, College of Social Work, Florida State Uni-
versity; Matthew O. Howard, School of Social Work, University of North
Carolina at Chapel Hill.
This trial was funded by Grant R03DA032517 from the National Institute on
Drug Abuse and a grant from the Fahs–Beck Fund for Research and Experimen-
tation, both awarded to Eric L. Garland, who was also supported by Grant
R34DA037005 from the National Institute on Drug Abuse during the preparation
of this article. We are grateful to the patients who participated in the trial.
Correspondence concerning this article should be addressed to Eric L.
Garland, College of Social Work and Huntsman Cancer Institute, Univer-
sity of Utah, Salt Lake City, UT 84112. E-mail: eric.garland@socwk
.utah.edu
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Journal of Consulting and Clinical Psychology © 2014 American Psychological Association
2014, Vol. 82, No. 2, 000 0022-006X/14/$12.00 DOI: 10.1037/a0035798
1
adherence monitoring, opioid treatment agreements and compli-
ance training, and cognitive behavioral substance misuse counsel-
ing (Jamison et al., 2010). Yet, new interventions are needed to
effectively address the maladaptive cognitive–affective processes
and appetitive responses elicited by pain, stress, and drug-related
cues that undergird the risk chain from chronic pain to opioid
misuse and addiction.
This risk chain initiates from prolonged use of opioids, which
produces physical dependence via neuroadaptations resulting in
tolerance, withdrawal, and, in some cases, opioid-induced hyper-
algesia (Chu, Angst, & Clark, 2008). Heightened pain sensitivity,
when coupled with tolerance to the analgesic effects of opioids,
can result in increased opioid craving (Ren, Shi, Epstein, Wang, &
Lu, 2009) and consumption (Martell et al., 2007), and can elicit
negative emotions that feed back to magnify pain perception. This
process may result in appraisal of pain sensations as threatening
and perseveration on the affective components of pain (Garland,
2012). Consequently, opioids are often misused to self-medicate
(Khantzian, 1997; Kirsh, Jass, Bennett, Hagen, & Passik, 2007) the
negative affective states and autonomic arousal that cause, co-
occur with, or result from pain (Jänig, 1995; Martenson, Cetas, &
Heinricher, 2009). As with pain, stress and negative affect can
become internal cues associated with past opioid use episodes that
elicit the habit of opioid use, particularly among opioid misusers
who take opioids to cope with emotional distress. Concomitantly,
the habitual drive to engage in prescription opioid misuse (includ-
ing unauthorized dose escalation) involves implicit neurocognitive
operations that promote craving and aberrant drug taking (Gold-
stein et al., 2009; Stacy & Wiers, 2010) by biasing attention toward
opioid-related cues (e.g., the sight of a pill bottle; Garland, Fro-
eliger, Passik, & Howard, 2013). Theory suggests that addiction
occurs when the motivation to obtain natural rewards is reorga-
nized around seeking drug-induced reward and the desire to alle-
viate dysphoria stemming from withdrawal and aversive experi-
ences (e.g., pain and stress; Alcaro & Panksepp, 2011; Koob & Le
Moal, 2008). In that regard, decreased responsiveness to natural
reinforcers has been observed among opiate-dependent individuals
and is robustly predictive of future opiate consumption (Lubman,
Allen, Peters, & Deakin, 2007, 2008; Lubman et al., 2009).
Hence, the problem of co-occurring chronic pain and prescrip-
tion opioid misuse may involve a cycle of behavioral escalation
where nociception and stress amplify pain and provoke recurrent
self-medication with opioids, which in turn biases attention toward
opioid-related cues that come to elicit the habit of opioid use
despite ever diminishing analgesia and increasing dysphoria (Gar-
land, Froeliger, Zeidan, Partin, & Howard, 2013). Despite such
risks, opioids remain medically necessary for many individuals
experiencing prolonged and intractable pain. Thus, therapeutic
interventions are needed to target comorbid pain and opioid mis-
use. Though cognitive behavioral therapy (CBT) has been shown
to produce therapeutic reductions in pain (Williams, Eccleston, &
Morley, 2012) and opioid misuse (Jamison et al., 2010) in isola-
tion, there is scant research on psychological treatments that si-
multaneously address symptoms of co-occurring chronic pain and
opioid misuse. To that end, we conducted an early-stage random-
ized controlled trial (RCT) of Mindfulness-Oriented Recovery
Enhancement (MORE; Garland, 2013), a novel multimodal inter-
vention that integrates mindfulness training, cognitive reappraisal
skills, and positive emotion regulation into a therapeutic approach
designed to modify attentional biases, habit behavior, affective
dysregulation, and autonomic stress responses underlying the feed-
back loop between chronic pain and opioid misuse behaviors.
Each of these three intervention components has been shown to
be beneficial in isolation. Mindfulness training leads to reductions
in pain (Gaylord et al., 2011; Kabat-Zinn, 1982; Rosenzweig et al.,
2010; Zeidan et al., 2011) that are mediated by increased nonre-
activity to aversive mental experiences and reinterpretation of
affectively laden pain sensations as innocuous sensory signals
(Garland, Gaylord, Palsson, Faurot, Mann, & Whitehead, 2012).
Moreover, mindfulness training produces salutary effects on emo-
tional distress (Grossman, Niemann, Schmidt, & Walach, 2004;
Hofmann, Sawyer, Witt, & Oh, 2010) and addiction-related factors
(Bowen et al., 2009; Garland, Froeliger, & Howard, 2013), includ-
ing attentional bias and autonomic cue-reactivity (Garland, Gay-
lord, Boettiger, & Howard, 2010). Similarly, cognitive reappraisal
has been shown to significantly decrease negative emotions and
downregulate stress physiology (Ochsner & Gross, 2005), as well
as reduce substance craving (Kober et al., 2010). In complemen-
tary fashion, positive emotion regulatory strategies (e.g., savoring
pleasant events) may upregulate positive affect, reduce anhedonia,
and promote psychological resilience (Garland et al., 2010).
MORE, which was originally tested as a treatment for alcohol
dependence (Garland, Gaylord, et al., 2010), capitalizes on the
synergy of these three treatment components by integrating them
into a multimodal intervention.
The aim of this study was to evaluate the feasibility of
developing a clinical trial comparing acute (pre–post) and lon-
ger term (3-month follow-up) efficacy of MORE with that of a
conventional support group (SG) in reducing chronic pain and
prescription opioid misuse. The study employed an active con-
trol condition that attempted to control for nonspecific thera-
peutic factors such as social interaction and support. We hy-
pothesized that participation in MORE would be associated
with significantly greater reductions in pain severity, pain in-
terference, stress symptoms, and desire for opioids than would
participation in a SG. We also hypothesized that compared with
SG participants, a significantly greater proportion of individu-
als completing MORE who met clinical criteria for prescription
opioid use disorder before treatment would no longer meet
opioid use disorder criteria following treatment. Insofar as
clinicians in the field must often make dichotomous diagnostic
judgments in practice and may need to ascertain the extent to
which a disorder can be rendered subclinical following treat-
ment (cf. Eftekhari et al., 2013), we were interested in whether
MORE could reduce symptoms below the clinical threshold for
opioid use disorder. Last, although MORE was designed to
target a wide array of cognitive, affective, and autonomic
mechanisms as detailed previously, in the present study, we
tested the effects of the intervention on a focused set of medi-
ators selected for their direct relevance to primary study out-
comes. Because emotional reactivity and maladaptive apprais-
als of pain and stress undergird the risk chain linking chronic
pain and opioid misuse, we hypothesized that the therapeutic
effects of MORE on pain severity and opioid use disorder status
would be associated with increased nonreactivity, cognitive
reappraisal, and reinterpretation of pain sensations as innocuous
sensory information.
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2GARLAND, MANUSOV, FROELIGER, KELLY, WILLIAMS, AND HOWARD
Method
Participants
Participants met study inclusion criteria if they reported recur-
rent pain (i.e., pain on more days than not) stemming from chronic
benign (i.e., noncancer-related) pain conditions, arthritis, or fibro-
myalgia and had been prescribed and had taken opioids for anal-
gesia daily or nearly every day (5 days/week) for at least the
past 90 days (Chou et al., 2009). Participants were recruited
between 2011 and 2012 from primary care clinics, pain clinics, and
neurology clinics in Tallahassee, Florida, through posted flyers, as
well as from online classified ads. Advertisements were focused on
recruiting participants who suffered from, and were prescribed
medicine for, chronic pain for a study focused on improving ways
to address problems with chronic pain and prescription pain med-
ication. Participants were assessed for comorbid psychiatric disor-
ders with the Mini-International Neuropsychiatric Interview 6.0
(Sheehan et al., 1998) and excluded if they were actively suicidal
or psychotic. Over the course of 1.5 years, 304 patients were
recruited; of these 304 patients, 115 met study criteria and were
randomly assigned to treatment. From this pool, 88 patients began
treatment, 70 completed treatment, and 52 completed 3-month
follow-up measures. See Figure 1 for the study flow diagram.
Procedures
Following a preliminary phone screening for eligibility, poten-
tial participants were screened in the first author’s lab. Individuals
who met eligibility criteria and agreed to participate in the study
completed a preintervention assessment where they reported de-
mographic and clinical information on questionnaires. Following
this assessment, participants were randomly allocated to MORE or
to the SG (which served as the active control condition). Order of
randomization was computer generated via simple randomization
in blocks of varying sizes (from six to eight) to preserve unpre-
dictability of allocation, and the allocation list was stored in a
protected file inaccessible to project staff involved in study enroll-
ment and assignment. Assessments were conducted by project staff
blind to each respondent’s group assignment, which was concealed
throughout the study. After participants had completed the 8-week
MORE or SG intervention, they returned to the lab to complete a
postintervention assessment including the same questionnaires ad-
ministered at pretreatment. Informed consent and study procedures
were conducted in compliance with the Florida State University
Human Subjects Committee.
MORE intervention. MORE unites complementary aspects
of mindfulness training, third-wave cognitive behavioral therapy
(CBT), and principles from positive psychology into an integrative
intervention strategy (Garland, 2013). Techniques drawn from
these therapeutic approaches were integrated into a manualized
eight-session group intervention designed to address the multiplic-
ity of pathogenic factors involved in chronic pain and long-term
opioid use. MORE sessions involved mindfulness training to target
automatic habit behavior and foster nonreactivity; positive reap-
praisal training to regulate negative emotions and foster a sense of
meaningfulness in life; and training in savoring pleasant events
Figure 1. Flow diagram of the progress through the study. ITT intention to treat; MORE Mindfulness-
Oriented Recovery Enhancement.
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3
MORE FOR CHRONIC PAIN AND OPIOID MISUSE
and emotions to ameliorate deficits in natural reward processing
and positive affectivity. Sessions were held in groups of between
eight and 12 individuals, were 2 hr in length, and were adminis-
tered by a master’s-level clinical social worker who had practiced
mindfulness for more than a decade and had clinical experience
offering mindfulness training to persons with psychiatric disorders.
This individual was supervised by the first author (the developer of
MORE and an experienced, licensed psychotherapist). The first
author reviewed video/audio recordings of the sessions on the
following day to monitor therapist adherence to the MORE treat-
ment manual via a fidelity checklist that tapped therapist behaviors
unique to MORE, essential to MORE, or compatible with MORE
but neither necessary nor unique to it, and behaviors that are
proscribed. All sessions were reviewed. Any deviations noted were
communicated weekly prior to the next session during clinical
supervision and corrected by the therapist in successive MORE
group sessions. Minor deviations (e.g., omission of nonessential
session content, abbreviated meditation debriefings) were ob-
served infrequently, and adherence improved over time; no major
deviations (e.g., proscribed behaviors) were noted.
Per the MORE treatment manual (Garland, 2013), sessions
offered instruction in applying mindfulness and related skills to the
following topics: discriminating among nociception, pain, and
suffering; gaining awareness of automaticity and coping habits in
chronic pain; disrupting the link among negative emotions, cata-
strophizing, and pain experience through reappraisal; refocusing
attention from pain and life stressors to savor pleasant experiences;
regulating opioid craving through mindful attention and aware-
ness; decreasing opioid craving through mindful stress reduction;
promoting acceptance instead of suppression of experience; and
developing a mindful recovery plan. Mindfulness training involved
mindful breathing and body scan techniques, with an emphasis on
developing metacognitive awareness and shifting attention from
affective to sensory processing of pain and craving sensations.
MORE participants were asked to engage in daily 15-min mind-
fulness practice sessions at home guided by a CD developed by the
first author. In addition, participants were asked to engage in 3 min
of mindful breathing prior to taking their opioid medication. This
exercise was intended to increase awareness of opioid craving,
clarify whether opioid use was driven by appetitive motivations
(i.e., urges) versus a legitimate need for pain relief, prevent un-
necessary opioid dosing by providing a nonpharmacologic means
of pain management, and synergistically increase the analgesic
efficacy of opioid medication. Participants were requested to log
how many minutes/day they engaged in homework practice, and
daily logs were examined by the clinician and discussed to facil-
itate therapy.
Support group intervention. The active control condition in
this study consisted of eight weekly, 2-hr conventional SG sessions
involving between eight and 12 participants, in which a master’s-
level clinical social worker (different from the MORE facilitator)
led discussion on topics pertinent to chronic pain and long-term
opioid use that were selected to roughly match corresponding
themes in the MORE intervention: the physical and psychological
dimensions of pain experience; ways of coping with chronic pain;
ways of coping with negative emotions; the impact of life events
on pain; the stigma and experience of opioid craving; the relation
between stress and craving; acceptance versus denial; and plans for
the future. This SG format was derived from the active, evidence-
based treatment condition outlined in the matrix model intensive
outpatient treatment manual (Rawson & McCann, 2006). SG par-
ticipants were guided to disclose feelings and thoughts about group
topics, as well as to provide advice and emotional support for their
peers. The clinician facilitated discussion using client-centered,
reflective listening techniques (Rogers, 2003) but did not prescribe
any specific recommendations for change. This intervention,
which typifies a commonly available form of conventional group
therapy for chronic pain, was found in prior RCTs to have equiv-
alent perceived credibility to mindfulness-based interventions and
to significantly reduce psychological distress among persons suf-
fering from chronic pain (Gaylord et al., 2011) and addiction
(Garland, Gaylord, et al., 2010).
The first author reviewed video/audio recordings of the sessions
on the following day to monitor therapist adherence to the SG
treatment manual via a fidelity checklist similar to that used in the
MORE intervention. As described previously, all sessions were
reviewed, and any deviations noted were communicated weekly
prior to the next session during clinical supervision and corrected
by the therapist in successive SG sessions. Minor deviations (e.g.,
use of superficial reflection vs. deep empathic responding, partic-
ipants monopolizing discussion time) were uncommon, and adher-
ence improved over time; no major deviations (e.g., proscribed
behaviors) were noted. SG participants were asked to engage in 15
min of journaling a day on chronic pain-related themes at home.
Participants were requested to record how many minutes/day they
engaged in journaling, and journals were examined by the clinician
and discussed to facilitate therapy.
Measures
Pain severity. Pain severity was measured with the four-item
pain severity subscale from the Brief Pain Inventory (BPI; ␣⫽
.87) a well-validated measure that has been widely used to tap
acute and chronic pain (Cleeland, 1994). Participants reported their
worst pain during the past week, least pain during the past week,
average pain, and current pain. Response options ranged from 0
(no pain)to10(pain as bad as I can imagine). An overall pain
severity score was computed by taking the mean of the four items.
Pain interference. Pain-related functional interference was
assessed with the pain interference subscale of the BPI (␣⫽.88).
Subjects rated on a scale ranging from 0 (does not interfere)to10
(completely interferes) the extent to which pain had interfered with
each of seven domains of normal functioning in the past week,
including general activity, mood, walking ability, normal work,
relations with other people, sleep, and enjoyment of life. An
overall pain interference score was computed by taking the mean
of the seven items.
Desire for opioids. A single item “How much do you want
your opioids right now?” anchored on a 10-point scale (1 not at
all,10extremely) was used to assess current desire for opioids.
We used this item as an indirect proxy for craving, due to the
possibility that asking directly about craving in this sample might
elicit defensive responding or denial. Single-item measures of
craving have been shown to distinguish high- from low-risk opioid
using chronic pain patients and predict opioid misuse (Wasan et
al., 2009; Weiss et al., 2010).
Self-reported opioid misuse. The Current Opioid Misuse
Measure (COMM; ␣⫽.83; Butler et al., 2007) was used to assess
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4GARLAND, MANUSOV, FROELIGER, KELLY, WILLIAMS, AND HOWARD
prescription opioid misuse. Participants responded to 17 items
rated on a Likert scale (0 never,4very often) regarding how
often in the past 30 days they had engaged in behaviors linked with
opioid misuse or took opioid medication in excessive doses or in
ways other than how it was prescribed. The original COMM
validation study conducted with patients treated in specialty pain
management clinics found that a score of 9 or more was suggestive
of prescription opioid misuse. However, according to a study of a
broad sample of chronic pain patients from a variety of primary
care settings who took prescription opioids but not necessarily on
a daily basis, receiver– operator characteristic curve analyses re-
vealed that a score of 13 or higher on the COMM had maximum
sensitivity and specificity to identify prescription opioid use dis-
order among chronic pain patients in primary care settings (Melt-
zer et al., 2011). We chose this more conservative COMM thresh-
old value to minimize false positives and because, similar to the
sample in Meltzer et al. (2011), our sample was broad and not
confined to patients from specialty pain clinics.
Nonreactivity. Nonreactivity to distressing thoughts and
emotions was measured with the seven-item nonreactivity subscale
(␣⫽.82) of the Five Facet Mindfulness Questionnaire (Baer,
Smith, Hopkins, Krietemeyer, & Toney, 2006). This subscale,
composed of items such as “When I have distressing thoughts or
images, I ‘step back,’ and I am aware of the thought or image
without getting taken over by it,” appears to tap metacognitive
decentering or disengagement from aversive experiences and has
been shown to mediate the effects of mindfulness training on
decreased pain (Garland et al., 2012).
Reinterpretation of pain sensations. Cognitive coping with
pain by reinterpreting painful sensations as innocuous sensory
experiences was assessed via the reinterpreting Pain Sensations
subscale of the Coping Strategies Questionnaire (Rosenstiel &
Keefe, 1983). This subscale has good internal consistency (␣⫽
.88) and is composed of six items including “I don’t think of it as
pain but rather as a dull or warm feeling,” and “I just think of it as
another sensation such as numbness.” Participants were asked to
report how much they generally engaged in this form of coping
when they felt pain. Responses are rated on a scale ranging from
0(never)to6(always); a reinterpretation of pain sensations total
score can be obtained by adding up the six items (range: from 0 to
36). Scores on this scale are meaningfully related to measures of
pain and adjustment to pain (Rosenstiel & Keefe, 1983) and have
been shown to mediate the therapeutic effects of mindfulness
training on chronic pain (Garland et al., 2012).
Reappraisal. Reappraisal was measured with the four-item
Positive Reappraisal subscale of the Cognitive Emotion Regula-
tion Questionnaire (CERQ; Garnefski & Kraaij, 2007), an inter-
nally consistent subscale (␣⫽.85) which asks the respondents
how often they “think [they] can become stronger as a result of
what has happened” or “look for positive sides to the matter” to
cope with stressful events. Responses are rated on a scale ranging
from 1 (almost never)to5(almost always); a reappraisal total
score can be obtained by summing the four items (range: from 4 to
20). In prior research, scores on the CERQ reappraisal scale were
prospectively predictive of lower levels of future affective symp-
toms (Garnefski & Kraaij, 2007), and changes in CERQ reap-
praisal scores mediated the stress-reductive effects of mindfulness
(Garland, Gaylord, & Fredrickson, 2011).
Affective and somatic symptoms of stress. The 56-item Cal-
gary Symptoms of Stress Inventory (C–SOSI; Carlson & Thomas,
2007) was used to assess affective and somatic symptoms of stress.
This scale, composed of eight internally consistent subscales with
adequate convergent and discriminant validity (Carlson &
Thomas, 2007), taps depression (␣⫽.89), sympathetic arousal
(␣⫽.75), anger (␣⫽.91), and cognitive disorganization (␣⫽
.84), as well as muscle tension (␣⫽.84), cardiopulmonary (␣⫽
.91), neurological (␣⫽.84), and upper respiratory stress symp-
toms (␣⫽.80).
Treatment credibility. We assessed participants’ perceptions
of the credibility of the treatment to which they were allocated
using three items based on the Attitudes Towards Treatment mea-
sure by Borkovec and Nau (1972). The measure was administered
at the end of Session 3 of each intervention condition, and a total
perceived credibility score was computed (␣⫽.86).
Analyses
We conducted per-protocol (PP) analyses as primary analyses
and used an additional intention-to-treat (ITT) approach for sen-
sitivity analyses. The PP sample consisted of participants who
attended at least five of the eight MORE or SG sessions and who
completed posttreatment assessments. Hypothesis testing in the PP
sample was conducted via an analysis of covariance (ANCOVA)
strategy (Frison & Pocock, 1992) for continuous outcomes (i.e.,
pain severity, pain interference, desire for opioids, and symptoms
of stress) and chi-square analysis for differences in proportions in
categorical outcomes (i.e., opioid use disorder status). In the case
of continuous outcomes, we controlled for pretreatment differ-
ences using the prerandomization measures as covariates. In ac-
cordance with the classical ANCOVA approach endorsed by
Frison and Pocock (1992) for analyzing clinical trial outcomes,
covarying baseline values performs statistical matching on the
prerandomization scores and ensures that comparisons of postran-
domization values by treatment group are independent of baseline
differences. In ANCOVA models, posttreatment values of out-
come variables were regressed on intervention group (MORE
vs. SG) after covarying pretreatment values. A similar set of
ANCOVA models was conducted by regressing 3-month
follow-up values on intervention group after covarying pretreat-
ment values. For our categorical outcome, we used a chi-square
analysis to determine whether there was a significant difference in
the proportion of participants who met opioid use disorder criteria
at baseline but no longer met clinical criteria for opioid use
disorder at posttreatment and 3-month follow-up. Because of miss-
ing data, the Nfor PP analyses for pre-to-posttreatment data ranged
from 65 to 67 and for follow-up data ranged from 50 to 51,
depending on the variable.
ITT analyses were conducted on the entire randomized sample
(N115). Of the 115 participants who were assessed at prein-
tervention and randomized to intervention conditions, 88 (76.5%)
attended one or more sessions, and 72 (62.6% of the randomly
allocated sample, 81.2% of those who attended one or more
sessions) completed the treatments. Three participants were lost to
the posttreatment assessment. The majority (93.0%) of nonstarters
cited their inability to meet the time commitment required by study
involvement as a reason for leaving the trial prior to the beginning
of treatment. Nonsignificant ttests and chi-square statistics indi-
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5
MORE FOR CHRONIC PAIN AND OPIOID MISUSE
cated there were no significant differences between participants
who dropped out versus those who completed the study across
demographic or clinical variables, including major depressive dis-
order and other psychiatric diagnoses. Similarly, there were no
significant differences in numbers of participants who met criteria
for opioid use disorder at baseline and then dropped out of MORE
and SG.
To analyze patterns of missing data, we performed Little’s
missing completely at random (MCAR) test (Little, 1988). The
pattern of missing data was consistent with being missing com-
pletely at random; thus, maximum-likelihood estimation was em-
ployed to handle missing data. To reduce potential bias resulting
from listwise deletion or last-observation-carried-forward tech-
niques, maximum-likelihood estimation procedures estimate the
variance-covariance matrix for all available data, including data
from cases assessed at only one time point (e.g., treatment non-
completers or nonstarters). For the ITT sample, hypothesis testing
was conducted using an ANCOVA strategy with maximum-
likelihood estimation conducted within the Analysis of Moment
Structures Version 17.0 (AMOS 17.0) software package, a method
that has been employed previously to assess clinical trial outcomes
in biomedical (Hurwitz et al., 2007) and psychotherapy (Durham,
Chambers, MacDonald, Power, & Major, 2003) studies. Addi-
tional ITT sensitivity analyses were conducted controlling for age,
gender, education, income level, and baseline self-reported opioid
misuse. For effect size estimates, we reported Cohen’s d, corre-
sponding to the magnitude of differences among the treatment
groups after controlling for baseline levels in the variable of
interest. Study sample size was determined a priori based on a
power analysis conducted with G
Power software (Version 3.1;
Erdfelder, Faul, & Buchner, 1996) using medium—large effect
size estimates derived from earlier trials demonstrating the effects
of MORE on clinical outcomes in alcohol-dependent individuals
(Garland, Gaylord, et al., 2010) and effects of mindfulness training
in chronic pain patients (Gaylord et al., 2011).
Results
Participant Characteristics
More than two thirds (68%) of participants were female (mean
age 48 years, SD 14), and the majority came from lower or
middle socioeconomic strata. The most common current chronic
pain diagnosis reported by participants across both intervention
conditions was lumbago (56.5%), followed by fibromyalgia
(20.0%), arthritis (7.0%), cervicalgia (6.0%), or “other” pain con-
ditions (10.5%). The most prevalent comorbid current psychiatric
condition was major depressive disorder (68.3%), followed by
generalized anxiety disorder (30.7%), alcohol use disorder
(12.8%), posttraumatic stress disorder (11.9%), and substance use
disorder (9.0%). Other less common comorbid conditions included
obsessive– compulsive disorder and social phobia. Using the es-
tablished cut point on the COMM, 72.2% of the total randomized
sample met criteria for prescription opioid use disorder.
There were no significant differences between MORE and SG
participants at baseline on any demographic, clinical, or outcome
variable for the PP or ITT sample (Table 1). MORE participants
had nonsignificantly higher incomes than SG participants.
Pre–Posttreatment Analyses
Pain severity and functional interference. Table 2 displays
the baseline, posttreatment, and follow-up means for MORE and
SG participants. For the primary analyses (per-protocol analyses),
the ANCOVA comparing the BPI pain severity score at posttreat-
ment for MORE and SG participants and including pretreatment
pain severity as a covariate revealed a statistically significant
effect of treatment condition, ␤⫽0.77, SE 0.36, 95% confi-
dence interval (CI) [0.05, 1.49], p.038, d0.50, with MORE
participants showing significantly lower levels of pain severity at
posttreatment than SG participants. The 10% baseline adjusted
mean pain reduction by posttreatment in the MORE group met the
threshold for minimally clinically significant change (Dworkin et
al., 2008). Similarly, the ANCOVA comparing the BPI pain func-
tional interference score at posttreatment for MORE and SG par-
ticipants and including pretreatment functional interference as a
covariate revealed a significant effect of treatment condition, with
MORE participants showing significantly lower levels of func-
tional interference at posttreatment than SG participants, ␤⫽1.24,
SE 0.40, 95% CI [.44, 2.03], p.003, d0.78.
Affective and somatic symptoms of stress. In per-protocol
analyses, the ANCOVA comparing the sympathetic arousal score
at posttreatment for MORE and SG participants controlling for
pretreatment sympathetic arousal revealed a statistically signifi-
cant effect of treatment condition, with MORE participants report-
ing significantly lower levels of sympathetic arousal at posttreat-
Table 1
Demographic and Clinical Characteristics of the Randomized
Chronic Pain Sample (N115)
Measure
MORE
(n57)
Support group
(n58)
Female, n(%) 40 (70) 38 (66)
Age (years) 49.3 13.68 47.4 13.56
Work status, full time, n(%) 15 (26) 14 (24)
Race
No response 7 (12) 4 (7)
American Indian 2 (4) 2 (3)
African American 10 (18) 11 (19)
White 36 (63) 39 (67)
Other 2 (4) 2 (3)
Income level
No response 16 (28) 18 (31)
Less than $20,000 12 (21) 15 (26)
$20,000–$39,999 11 (19) 16 (28)
$40,000–$59,999 7 (12) 3 (5)
$60,000–$79,999 6 (11) 3 (5)
More than $80,000 5 (9) 3 (5)
Education, some college, n(%) 40 (70) 41 (71)
Primary pain condition, n(%)
Lumbago 30 (53) 35 (60)
Fibromyalgia 11 (19) 12 (21)
Arthritis 4 (7) 4 (7)
Cervicalgia 5 (9) 2 (3)
Other 7 (12) 5 (9)
Opioid use disorder status, n(%) 41 (72) 42 (72)
Note. There were no significant between-groups differences on any of
these variables. Positive opioid use disorder status was determined by
exceeding a cut point of 13 on the Current Opioid Misuse Measure.
MORE Mindfulness-Oriented Recovery Enhancement; SG support
group.
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6GARLAND, MANUSOV, FROELIGER, KELLY, WILLIAMS, AND HOWARD
ment than SG participants, ␤⫽3.02, SE 1.40, 95% CI [.24,
5.81], p.034, d0.45. Similarly, with pretreatment values
controlled, MORE participants endorsed lower levels of self-
reported neurological symptoms of stress at posttreatment than SG
patients, ␤⫽1.84, SE 0.94, 95% CI [–.04, 3.73], p.055, d
0.41. No other between-groups differences were observed on the
remaining subscales of the C–SOSI.
Desire for opioids. In per-protocol analyses, the ANCOVA
comparing the desire for opioids score at posttreatment for MORE
and SG participants and including pretreatment desire for opioids
as a covariate revealed a statistically significant effect of treatment
condition, with MORE participants showing significantly less de-
sire for opioids at posttreatment than SG patients, ␤⫽1.39, SE
0.62, 95% CI [0.15, 2.63], p.027, d0.50. MORE patients
continued to exhibit significantly less desire for opioids at post-
treatment, even after controlling for pre–post change in pain se-
verity, ␤⫽1.31, SE 0.63, 95% CI [0.05, 2.57], p.043, d
0.46, suggesting that this decrease in desire for opioids was par-
tially independent from the overall pain reduction resulting from
participation in MORE. Indeed, change in desire for opioids was
not significantly correlated with change in pain severity, r.07,
p.60, or pain interference, r.19, p.11.
Opioid use disorder. Though inspection of opioid misuse
means revealed that participants in both MORE and SG exhibited
decreased self-reported opioid misuse scores over the course of
treatment, we wanted to know whether significantly fewer partic-
ipants continued to meet criteria for disordered opioid use follow-
ing treatment with MORE than with the SG. Using a validated cut
point on the COMM (Meltzer et al., 2011), we identified individ-
uals who met criteria for opioid use disorder at baseline. Chi-
square analysis revealed that relative to those in the SG, a signif-
icantly greater proportion of individuals meeting opioid use
disorder criteria at baseline who participated in MORE no longer
met opioid use disorder criteria following treatment. There was a
63% reduction in opioid use disorders in the MORE group, com-
pared with a 32% reduction in the SG,
2
3.74, p.05.
Sensitivity analyses. Results of sensitivity analyses (ITT
analyses) supported the PP findings on acute effects of treatment.
ANCOVAs conducted with maximum-likelihood estimation of
missing data revealed a significant main effect for treatment con-
dition for pain severity (␤⫽0.74, SE 0.35, 95% CI [0.05, 1.43],
p.034, d0.54), functional interference (␤⫽1.21, SE .36,
95% CI [0.50, 1.92], p.001, d0.75), sympathetic arousal
(␤⫽3.02, SE 1.34, 95% CI [0.40, 5.62], p.02, d0.54),
neurological stress symptoms (␤⫽1.84, SE 0.90, 95% CI [0.08,
3.60], p.04, d0.47), and desire for opioids (␤⫽1.39, SE
0.59, 95% CI [0.22, 2.56], p.02, d0.57), with outcomes
favoring the MORE group. These main effects for treatment re-
mained significant even after controlling for age, gender, educa-
tion, income level, and baseline opioid use disorder status. Simi-
larly, in an ITT analysis controlling for the same set of covariates,
participation in MORE was associated with significantly lower
rates of opioid use disorder at posttreatment.
Follow-Up Analyses
PP and ITT ANCOVAs of data at the 3-month follow-up re-
vealed a statistically significant effect of treatment condition, with
MORE patients showing significantly lower levels of pain severity
(PP results: ␤⫽0.92, SE 0.44, 95% CI [0.03, 1.80], p.04,
d0.56; ITT results: ␤⫽1.06, SE 0.43, 95% CI [0.21, 1.91],
p.014, d0.63) and significantly less pain interference (PP
results: ␤⫽1.82, SE .62, 95% CI [0.57, 3.06], p.005, d
0.78; ITT results: ␤⫽1.82, SE 0.58, 95% CI [0.67, 2.97], p
.002; d0.84) at follow-up than SG patients. The 22% baseline
adjusted mean interference reduction by follow-up in the MORE
Table 2
Mean (SD) Value of Outcome and Mediation Variables at Baseline (T1), Posttreatment (T2), and 3-Month Follow-Up (T3) by
Treatment Condition (Mindfulness-Oriented Recovery Enhancement vs. Support Group)
Variable
Time 1 Time 2 Time 3
MORE
M (SD)
SG
M (SD)
MORE
M (SD)
SG
M (SD)
MORE
M (SD)
SG
M (SD)
Primary outcomes
Pain severity 5.44 (1.40)
a
5.49 (1.54)
a
4.86 (1.38)
b
5.71 (1.58)
a
4.77 (1.95)
b
6.10 (1.48)
a
Pain interference 5.87 (2.15)
a
6.37 (2.02)
a
5.22 (1.88)
b
6.90 (1.50)
a
4.60 (2.66)
b
6.75 (1.86)
a
Opioid craving 4.36 (3.00)
a
5.03 (3.44)
a
2.60 (1.61)
b
4.32 (3.35)
a
3.82 (3.15)
a
4.45 (2.91)
a
Opioid misuse 17.19 (7.90)
a
18.62 (11.24)
a
11.27 (7.67)
b
15.68 (9.56)
b
13.90 (6.91)
a
16.44 (8.28)
a
Secondary outcomes
Sympathetic arousal symptoms 17.84 (5.58)
a
18.76 (6.64)
a
14.65 (7.52)
b
18.89 (5.96)
a
——
Depression symptoms 10.63 (6.82)
a
11.50 (7.37)
a
8.20 (7.09)
a
10.76 (6.44)
a
——
Anger symptoms 10.36 (6.48)
a
9.00 (6.11)
a
9.91 (6.39)
a
9.10 (5.47)
a
——
Cognitive symptoms 7.57 (4.59)
a
8.94 (5.38)
a
5.80 (3.54)
a
7.55 (5.19)
a
——
Muscle tension symptoms 17.87 (6.56)
a
20.24 (7.30)
a
16.50 (7.42)
a
18.26 (6.86)
a
——
Cardiopulmonary symptoms 5.45 (4.42)
a
8.46 (6.62)
a
4.00 (4.06)
a
7.68 (6.24)
a
——
Neurological symptoms 6.26 (5.07)
a
8.08 (5.80)
a
3.90 (3.58)
b
6.68 (5.20)
a
——
Upper respiratory symptoms 5.43 (5.08)
a
5.96 (4.72)
a
5.20 (5.11)
a
7.47 (4.70)
a
——
Potential mediators
Nonreactivity 21.23 (4.58)
a
22.16 (5.70)
a
23.34 (3.55)
b
22.18 (4.17)
a
——
Reappraisal 13.09 (3.82)
a
13.22 (4.25)
a
16.31 (6.89)
b
13.47 (4.17)
a
——
Reinterpretation of pain sensations 8.01 (6.85)
a
9.29 (8.52)
a
12.40 (7.81)
b
8.28 (8.21)
a
——
Note. Per row, variables that do not share the same subscript significantly differ at p.05. MORE Mindfulness-Oriented Recovery Enhancement;
SG support group. Because of missing data, ns ranged from 113 to 115 at Time 1, 65 to 67 at Time 2, and 50 to 51 for Time 3, depending on the variable.
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7
MORE FOR CHRONIC PAIN AND OPIOID MISUSE
group met threshold for minimally clinically significant change
(Dworkin et al., 2008). However, there was no significant effect of
treatment condition on desire for opioids or opioid use disorder
status at 3-month follow-up.
Therapeutic Mechanisms
Statistically significant changes from pre- to posttreatment were
observed in all three potential mediating variables (see Table 2).
To explore the therapeutic mechanisms of MORE on pain severity,
we conducted a multivariate path analysis on the ITT sample (see
Figure 2). Path analysis revealed that residualized change (pre–
post) in reinterpretation of pain sensations and residualized change
(pre–post) in nonreactivity significantly predicted follow-up levels
of pain severity, controlling for baseline levels of pain severity,
baseline opioid use disorder status, age, gender, education, and
income level. Change in reappraisal did not predict pain severity.
Model fit statistics were adequate,
2
/df 1.42; incremental fit
index (IFI) .92; root-mean-standardized error of approximation
(RMSEA) .06, 95% CI [0.00, 0.11]); the indirect effects of
reinterpretation of pain sensations (Sobel-Goodman test 2.17,
SE 0.18, p.03), and nonreactivity (Sobel–Goodman test
1.97, SE 0.18, p.049) were both significant.
To elucidate correlates of change in opioid use disorder status,
we evaluated three logistic regression models with treatment group
and residualized change (pre–post) in each potential mediating
variable as predictors of posttreatment opioid use status and base-
line opioid use disorder status as a covariate. Residualized change
in nonreactivity significantly predicted opioid use disorder status
at posttreatment, ␤⫽– 0.24, SE 0.13, p.03, odds ratio
(OR) .73, 95% CI [0.63, 0.98], such that greater increases in
nonreactivity were associated with reduced odds of meeting opioid
use disorder criteria following treatment. In contrast, changes in
reinterpreting pain sensations and reappraisal did not predict opi-
oid use disorder status.
Additionally, because unauthorized opioid use and increased
wanting for opioids can arise as a result of undertreated pain (i.e.,
pseudoaddiction; Jamison et al., 2011), we conducted an explor-
atory multivariate path analysis on the ITT sample to examine
whether reduced desire for opioids mediated the relation between
treatment-related decreases in pain severity on residualized change
in opioid misuse at posttreatment. Results from this path model
(
2
/df 1.48; IFI .92; RMSEA .07, 95% CI [0.00, 0.12])
indicated that desire for opioids was not significantly associated
with reductions in pain and opioid misuse at posttreatment.
Last, we examined whether participation in MORE modulated
the strength of the relationship between desire for opioids and
self-reports of opioid misuse. We found that prior to treatment,
desire for opioids was significantly associated with opioid misuse
among participants randomly assigned to the SG (r.32, p.02)
and MORE (r.53, p.001) treatments. At posttreatment,
desire for opioids was significantly associated with opioid misuse
among SG participants (r.51, p.001) but was uncorrelated
with opioid misuse among MORE participants (r–.00, p.99).
Using Fisher’s r-to-ztransformation, we found that these two
correlation coefficients were significantly different, z2.17, p
.01, suggesting that MORE significantly decreased the strength of
the relationship between desire for opioids and self-reported opioid
misuse.
Treatment Credibility
Analysis of the credibility scale revealed no significant differ-
ence in credibility between treatment groups, F(1, 61) 3.15, p
.08 (MORE M21.37, SD 4.03; SG M19.31, SD 4.87).
Perceived credibility was not significantly correlated with any
treatment outcomes.
Adherence to At-Home Practice
Adherence to at-home practice exercises during active treatment
was assessed via daily homework logs: 73.1% of the PP sample
complied and recorded their homework practice on these logs.
There was no significant between-groups difference in duration of
weekly homework practice, F(1, 48) 2.13, p.15; the average
number of minutes practiced a week by MORE group participants
was 166.9 (SD 93.4), whereas the average number of minutes
practiced a week by SG participants was 114.7 (SD 149.6).
Discussion
Study results indicate that MORE significantly reduced symp-
toms associated with chronic pain and prescription opioid misuse
among a sample of patients receiving long-term opioid analgesic
pharmacotherapy. Specifically, MORE led to greater posttreatment
reductions in pain severity and pain-related functional interference
than did participation in a SG, which were maintained for 3 months
following the end of treatment. MORE also decreased symptoms
of self-reported sympathetic stress arousal by posttreatment. In
addition, by the posttreatment assessment point, MORE led to
short-term reductions in desire for opioid medication and amelio-
rated disordered opioid use in nearly two thirds of patients who
completed treatment.
The observed therapeutic effect of MORE on pain severity and
interference was modest yet clinically significant at 3-month
follow-up according to benchmarks for chronic pain treatment
RCTs established by Dworkin et al. (2008). This finding is notable
given that many participants were taking prescription opioids in
Figure 2. Multivariate path model of therapeutic mechanisms of
Mindfulness-Oriented Recovery Enhancement (MORE) on pain severity
(N115). Model parameters reflect adjustment for the following covari-
ates: age, gender, education, income level, and baseline opioid use disorder
status.
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8GARLAND, MANUSOV, FROELIGER, KELLY, WILLIAMS, AND HOWARD
large doses and that many participants reported a discrete site of
pain and symptoms indicative of a specific anatomical abnormality
or degeneration suggestive of organic etiology (e.g., arthritis,
degenerative joint disease). Thus, MORE may have not been
merely treating a psychological overlay but also modulating the
impact of chronic injury or disease. Our prior path analytic re-
search indicated that mindfulness training may alleviate chronic
pain by enhancing nonreactivity toward distressing thoughts and
emotions, as well as by promoting a shift from affective to sensory
processing of pain sensations (Garland et al., 2012). Congruent
with this prior research, in the present trial, we observed signifi-
cant increases in nonreactivity and reinterpretation of pain sensa-
tions that statistically mediated the pain-reductive effects of
MORE; replication of these findings across two distinct samples
suggests that these factors may indeed be important therapeutic
mechanisms of action underpinning the effect of mindfulness on
chronic pain. A recent study also demonstrated that MORE led to
significant reductions in pain attentional bias coupled with im-
proved perceived control over pain (Garland & Howard, 2013).
Additional research is needed to elucidate the pathways by which
mindfulness modulates chronic pain symptoms and pain-related
impairment.
Immediately following treatment (i.e., posttreatment assess-
ment), participants receiving MORE reported significant reduc-
tions in their desire for opioids; it is important to note that this
therapeutic effect was statistically independent from pain reduc-
tion. Given that a subjective “wanting” for opioids is characteristic
of dopaminergically mediated craving responses (Robinson &
Berridge, 2008), this reduction in desire for opioid medication may
be reflective of a decrease in craving. In that regard, mindfulness-
based relapse prevention has been shown to reduce substance
craving (Bowen et al., 2009). Notably, participation in MORE was
associated with decreased correlation strength between desire for
opioids and self-reported opioid misuse, suggesting that MORE
may have decoupled craving responses from addictive behaviors.
This interpretation is consistent with models suggesting that mind-
fulness facilitates awareness, acceptance, and nonjudgment of
craving without engaging in addictive responses (Garland, Fro-
eliger, & Howard, 2013; Witkiewitz, Bowen, Douglas, Tsu, 2013).
Nonetheless, given the multidimensionality of craving, our ability
to measure this construct may have been constrained by our use of
a single question item. Effects on desire for opioids waned by the
3-month follow-up, suggesting that booster sessions might be
necessary to sustain this effect over time. After the conclusion of
the MORE intervention, participants may have practiced mindful-
ness skills less frequently (e.g., the 3-min mindful breathing ex-
ercise prior to taking opioids), resulting in a loss of this treatment
benefit. Unfortunately, we did not collect measures of mindfulness
practice during the follow-up period to verify this hypothesis.
Future studies should carefully measure adherence to home prac-
tice during the follow-up period.
Though participation in both study interventions was associated
with decreased self-reported opioid misuse, MORE led to a sig-
nificantly greater reduction in the proportion of patients who
continued to meet criteria for prescription opioid use disorder by
the posttreatment assessment point. MORE also led to increased
nonreactivity, which was associated with reduced odds of meeting
opioid use disorder criteria following treatment. These findings
may be of direct relevance to clinicians who must make dichoto-
mous judgments in practice (e.g., whether a treatment can promote
remission from disordered opioid use or a high-risk patient can be
continued on opioid pharmacotherapy). Though promising, these
results are derived from a self-report instrument (COMM) used to
determine the presence of opioid use disorder. Future studies
should employ structured diagnostic evaluations both pre- and
posttreatment to determine whether participation in MORE is
associated with greater occurrence of remission from prescription
opioid use disorder.
The primary limitation of the present study was our inability to
quantify differences in opioid dosing. While we asked open-ended
questions about opioid dosing, missing data and the extreme vari-
ability in quality of responses made it impossible to quantify this
variable for use as a covariate in the current study. Theoretically,
randomization equated these two groups with regard to opioid
dosing—this is likely because there were no other significant
between-groups differences observed at baseline. For a pilot study
of this nature, focusing on reduced opioid dosing as a study
outcome was not appropriate because it may not have been med-
ically warranted, it could have made recruitment difficult, and the
prescribing physicians were not members of the investigative
team. We are currently implementing a larger and longer term
RCT to assess opioid dosing in a fine-grained manner prior to,
during, and following treatment with MORE to examine changes
in dose over time. Among other study aims, we specifically assess
the extent to which chronic pain patients participating in MORE
are able to reduce their opioid doses over time relative to chronic
pain patients in an active control SG condition similar to the one
used in this study. In addition, though we qualitatively monitored
therapist adherence continuously throughout the trial, this study
was also limited by lack of quantitative tracking of nonadherence
and assessment of the relationship between treatment fidelity and
outcome. The study was also limited by the use of different
therapists for the MORE and SG interventions, which, despite the
fact they had comparable levels of clinical experience with the
study population, may have resulted in therapist effects that could
have confounded study outcomes. Also, there were substantial
numbers of attriters and nonstarters in the study, although the
attrition rate was comparable to that in other intervention studies of
individuals with prescription opioid use disorders (Weiss et al.,
2011). The time demands required by study participation, the
transient nature of the study sample, and the possibility that prior
to the study interventions some participants might have experi-
enced an unreported change in medical status or engaged in
medical procedures requiring convalescence may have precluded
full participation in the trial.
Finally, although MORE is founded on a conceptual framework
that incorporates a number of interconnected and complex mech-
anisms (for reviews, see Garland, Boettiger, & Howard, 2011;
Garland, Froeliger, & Howard, 2013a; Garland, Froeliger, Zeidan,
Partin, & Howard, 2013), the present study was limited in its
measurement of a circumscribed subset of these manifold treat-
ment targets. Prior research identified significant effects of MORE
on attentional bias for substance-related cues and autonomic re-
covery from stress-primed cue exposure (Garland, Gaylord, et al.,
2010), and ongoing research in our lab is currently assessing the
effects of MORE on habit responses, natural reward processing,
and opioid cue-reactivity (Garland, Froeliger, & Howard, 2013b).
Taken together, these studies are beginning to outline the multiple
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9
MORE FOR CHRONIC PAIN AND OPIOID MISUSE
pathways by which MORE may exert salutary effects. Nonethe-
less, additional research is needed. Future investigations should
carefully assess the reasons for nonstarting and attrition, use mul-
tiple therapists in each treatment condition, carefully monitor
opioid dosing (including use of urine toxicology screens), quanti-
tatively evaluate treatment fidelity, and employ a wider set of
self-report measures coupled with psychophysiological and neu-
roimaging paradigms to comprehensively probe the therapeutic
mechanisms of MORE and predictors of treatment response.
In conclusion, study results indicate that among patients suffer-
ing from chronic pain, MORE reduces pain severity and functional
interference for up to 3 months following treatment and decreases
sympathetic stress arousal, desire for opioids, and disordered opi-
oid use at the end of treatment. These outcomes appear to be linked
with key therapeutic mechanisms, including mindful disengage-
ment from negative appraisals and reorienting of attention onto
interoceptive data with less affective bias. By strengthening these
and other cognitive–affective processes, MORE may facilitate the
generation of adaptive reappraisals and modulate intervention tar-
gets implicated in distress intolerance and addictive behavior.
Findings from this early-stage RCT demonstrate preliminary fea-
sibility and efficacy of MORE as a treatment for co-occurring
prescription opioid misuse and chronic pain, a vexing problem of
increasing medical and social significance.
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Received August 5, 2013
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Accepted December 23, 2013
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Full-text available
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Prominent neuroscience models suggest that addictive behavior occurs when environmental stressors and drug-relevant cues activate a cycle of cognitive, affective, and psychophysiological mechanisms, including dysregulated interactions between bottom-up and top-down neural processes, that compel the user to seek out and use drugs. Mindfulness-based interventions (MBIs) target pathogenic mechanisms of the risk chain linking stress and addiction. This review describes how MBIs may target neurocognitive mechanisms of addiction at the attention-appraisal-emotion interface. Empirical evidence is presented suggesting that MBIs ameliorate addiction by enhancing cognitive regulation of a number of key processes, including: clarifying cognitive appraisal and modulating negative emotions to reduce perseverative cognition and emotional arousal; enhancing metacognitive awareness to regulate drug-use action schema and decrease addiction attentional bias; promoting extinction learning to uncouple drug-use triggers from conditioned appetitive responses; reducing cue-reactivity and increasing cognitive control over craving; attenuating physiological stress reactivity through parasympathetic activation; and increasing savoring to restore natural reward processing. Treatment and research implications of our neurocognitive framework are presented. We conclude by offering a temporally sequenced description of neurocognitive processes targeted by MBIs through a hypothetical case study. Our neurocognitive framework has implications for the optimization of addiction treatment with MBIs.
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Context: Although drug cues reliably activate the brain's reward system, studies rarely examine how the processing of drug stimuli compares with natural reinforcers or relates to clinical outcomes. Objectives: To determine hedonic responses to natural and drug reinforcers in long-term heroin users and to examine the utility of these responses in predicting future heroin use. Design: Prospective design examining experiential, expressive, reflex modulation, and cortical/attentional responses to opiate-related and affective stimuli. The opiate-dependent group was reassessed a median of 6 months after testing to determine their level of heroin use during the intervening period. Setting: Community drug and alcohol services and a clinical research facility. Participants: Thirty-three opiate-dependent individuals (mean age, 31.6 years) with stabilized opiate-substitution pharmacotherapy and 19 sex- and age-matched healthy non-drug users (mean age, 30 years). Main Outcome Measures: Self-ratings, facial electromyography, startle-elicited postauricular reflex, and event-related potentials combined with measures of heroin use at baseline and follow-up. Results: Relative to the control group, the opiate-dependent group rated pleasant pictures as less arousing and showed increased corrugator activity, less postauricular potentiation, and decreased startle-elicited P300 attenuation while viewing pleasant pictures. The opiate-dependent group rated the drug-related pictures as more pleasant and arousing, and demonstrated greater startle-elicited P300 attenuation while viewing them. Although a startle-elicited P300 amplitude response to pleasant (relative to drug-related) pictures significantly predicted regular (at least weekly) heroin use at follow-up, subjective valence ratings of pleasant pictures remained the superior predictor of use after controlling for baseline craving and heroin use. Conclusions: Heroin users demonstrated reduced responsiveness to natural reinforcers across a range of psychophysiological measures. Subjective rating of pleasant pictures robustly predicted future heroin use. Our findings highlight the importance of targeting anhedonic symptoms within clinical treatment settings.
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Prescription opioid misuse and addiction among chronic pain patients are emerging public health concerns of considerable significance. Estimates suggest that more than 10% of chronic pain patients misuse opioid analgesics, and the number of fatalities related to nonmedical or inappropriate use of prescription opioids is climbing. Because the prevalence and adverse consequences of this threat are increasing, there is a pressing need for research that identifies the biobehavioral risk chain linking chronic pain, opioid analgesia, and addictive behaviors. To that end, the current manuscript draws upon current neuropsychopharmacologic research to provide a conceptual framework of the downward spiral leading to prescription opioid misuse and addiction among chronic pain patients receiving opioid analgesic pharmacotherapy. Addictive use of opioids is described as the outcome of a cycle initiated by chronic pain and negative affect and reinforced by opioidergic-dopamingeric interactions, leading to attentional hypervigilance for pain and drug cues, dysfunctional connectivity between self-referential and cognitive control networks in the brain, and allostatic dysregulation of stress and reward circuitry. Implications for clinical practice are discussed; multimodal, mindfulness-oriented treatment is introduced as a potentially effective approach to disrupting the downward spiral and facilitating recovery from chronic pain and opioid addiction.