A Trial of A Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) For Chronic Pain in General Practice - Pilot Outcome and Process Results

3/4/2020 A Trial of a Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) for Chronic Pain in General Practice:
actice: Pilot Outco…
S D
T J
P
J Pain. 2013 Nov; 14(11): 1398–1406. PMCID: PMC3824075
doi: 10.1016/j.jpain.2013.06.011: 10.1016/j.jpain.2013.06.011 PMID: 24035351
A Trial of a Brief Group-Based Form of Acceptance and Commitment

Therapy (ACT) for Chronic Pain in General Practice: Pilot Outcome
and Process Results
Lance M. McCracken,∗†∗ Ayana Sato,‡ and Gordon J. Taylor‡
∗Health Psychology Section, Psychology Department, King's College London, London, United Kingdom
†INPUT Pain Management, Guy's and St Thomas' Hospitals, London, United Kingdom
‡Centre for Pain Research, University of Bath, Bath, United Kingdom
Lance M. McCracken: Lance.McCracken@kcl.ac.uk

∗Address reprint requests to Lance M. McCracken, PhD, Health Psychology Section, Psychology Department,
King's College London, Guy's Campus, London SE1 9RT, United Kingdom. Lance.McCracken@kcl.ac.uk
Received 2013 Mar 8; Revised 2013 May 31; Accepted 2013 Jun 28.
Copyright © 2013 Elsevier Inc.
This document may be redistributed and reused, subject to certain conditions.
Abstract
Acceptance and commitment therapy (ACT) is a developing approach for chronic pain. The current study
was designed to pilot test a brief, widely inclusive, local access format of ACT in a UK primary care
setting. Seventy-three participants (68.5% women) were randomized to either ACT or treatment as usual
(TAU). Many of the participants were aged 65 years or older (27.6%), were diagnosed with fibromyalgia
(30.2%) and depression (40.3%), and had longstanding pain (median = 10 years). Standard clinical
outcome measures included disability, depression, physical functioning, emotional functioning, and rated
improvement. Process measures included pain-related and general psychological acceptance. The
recruitment target was met within 6 months, and 72.9% of those allocated to ACT completed treatment.
Immediately post treatment, relative to TAU, participants in ACT demonstrated lower depression and
higher ratings of overall improvement. At a 3-month follow-up, again relative to TAU, those in ACT
demonstrated lower disability, less depression, and significantly higher pain acceptance; d = .58, .59, and
.64, respectively. Analyses based on intention-to-treat and on treatment “completers,” perhaps predictably,
revealed more sobering and more encouraging results, respectively. A larger trial of ACT delivered in
primary care, in the format employed here, appears feasible with some recommended adjustments in the
methods used here (Trial registration: ISRCTN49827391).
Perspective
This article presents a pilot randomized controlled trial of ACT for chronic pain in a primary care setting in
the United Kingdom. Both positive clinical outcomes and ways to improve future trials are reported.
Key words: Acceptance and commitment therapy, cognitive behavioral therapy, psychological flexibility,
chronic pain, randomized controlled trial, pilot
Broadly, cognitive behavioral approaches to chronic pain, including cognitive behavioral therapy (CBT),
have been the predominant psychological treatment for most of the past 30 years.12,21 These approaches,
as the name implies, focus on creating cognitive and behavioral change to help people who have chronic
pain to suffer less, function better, and use fewer medical services for their pain. Generally the evidence for
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3824075/?report=printable 1/15
3/4/2020 A Trial of a Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) for Chronic Pain in General Practice: Pilot Outco…
CBT for chronic pain is supportive.4,22 However, the benefits of CBT for chronic pain are not as large and
general as they could or should be, including only small effects on disability.37 Some improvement in the
CBT approach may be needed.
It is has been suggested that researchers stop testing package treatments that essentially attempt to treat the
many problems of chronic pain with many methods in combination.4 There are calls to focus on
therapeutic mechanisms, or processes, and moderators, the answers to the questions of how treatment
works and for whom.4,15,23,37 There are also calls for approaches that include more comprehensive and
integrative theoretical modes.9,11
Acceptance and commitment therapy (ACT)7 is a form of CBT that may help advance the field of chronic
pain management. ACT is not a package-based approach—it is process focused, primarily including a
therapeutic process called psychological flexibility. Psychological flexibility is the ability to either engage
in a behavior pattern or change a behavior pattern depending on one's goals and what the situation affords,
in a context of interacting cognitive and direct, noncognitive, influences on behavior.6 Psychological
flexibility includes 6 constituent processes: acceptance, present-focused awareness, values, cognitive
defusion, self-as-observer, and committed action. ACT is comprehensive, encompassing both healthy and
unhealthy psychological processes; integrative; and theoretically based. It focuses on behavior change and
on any manipulable influences that can be applied in changing behavior, incorporating influences based in
emotional experiences, thoughts, beliefs, and social context. ACT is based on an extension of operant
theory that includes a model of cognition and cognitive regulation of behavior, called relational frame
theory, and on a philosophy of science called functional contextualism.8
There are now at least 5 randomized controlled clinical trials (RCTs) of ACT related to chronic pain that
support its efficacy.2,27,34-36 A wide variety of formats of delivery have been tested but none of these
were specifically designed for high-efficiency screening and wide inclusion, for recruitment and delivery
in primary care in the UK, over a short time frame, and in a group treatment context. The only ACT-based
treatment tested within the UK National Health Service is a high-intensity interdisciplinary model,
including more than 90 hours of treatment time, delivered in a specialty hospital setting.20
The purpose of this study was to pilot test a brief version of ACT for chronic pain in a primary care
setting, in a small RCT. The treatment tested here was designed to be broadly accessible, with highly
inclusive recruitment criteria, and efficient to deliver, including just 4 sessions over 2 weeks.18 An array
of potential primary outcome and treatment process variables were collected, including disability,
depression, physical functioning, pain, and acceptance, to determine a best primary outcome and process
measures for a larger trial of the same treatment. Specific power calculations were not a part of the
planning of the study; hence, the primary focus was not on testing predictions for specific, significant
outcome effects. The overall objective here was to test key trial methods to plan for a larger study, to
gather data for future power calculations, and to consider ways to enhance the treatment or the methods for
studying it.
Method
Trial Design
This study included a randomized pilot trial of group treatment for people with chronic pain recruited from
general practice. After baseline assessment, participants were randomized to ACT plus treatment-as-usual
(TAU) or TAU alone (1:1) based on computer-generated random numbers. The allocation was not
concealed from the participants, treatment providers, or the researcher; however, assessment and data entry
were conducted blind to allocation. Posttreatment assessment was conducted within 2 weeks of treatment
completion (with parallel assessment of those in the TAU group) and at a 3-month follow-up. Sample size
was determined on a plan to recruit between 8 and 12 participants for each of 3 ACT groups. A total
sample of 60 participants was the target. This study was approved by the regional research ethics
committee (reference: 09/H0107/99) and National Health Service Research and Development committee at
the Royal National Hospital for Rheumatic Diseases in Bath.
Recruitment
Participants for this study were recruited from general medical practices in the southwest of England.
These practices were recruited through the regional Primary Care Research Network. The practices
expressing interest included 119,000 registered patients, and the individual practice list sizes ranged from
5,300 to 13,000. Recruitment was conducted over a period of 2 months in each of 3 separate areas in the
southwest primarily during the first quarter of 2012.
Potential participants at each of the practices were identified through record searches applying the
inclusion criteria. Inclusion in the study required persistent pain of longer than 3 months' duration, a pain-
related consultation with the general practitioner (GP) in the past 6 months, significant pain-related distress
and disability, consistent analgesic medications use, ability to communicate in English, and age 18 years or
older. Those needing further medical tests or procedures, or with conditions expected by the GP to
interfere with participation in the treatment, were excluded.
Potential participants meeting eligibility criteria were sent an invitation letter, trial information sheet,
consent form, and screening questionnaire by their GPs (N = 481). Participants who wished to take part
returned their signed consent forms and the screening questionnaire to the research team by post and were
screened for eligibility (n = 102). Twenty-nine potential participants were excluded at this stage, 22 for not
meeting criteria. Seven did not provide consent. Seventy-three potential participants were randomized to
ACT (n = 37) or treatment as usual (n = 36). A consort diagram is included in Fig 1.
Part of the screening process was based on the disability rating portion of the chronic pain grading
questionnaire by Von Korff and colleagues.28 Eligible participants needed to rate the level of interference
with their daily activities from pain a 4 or higher on a scale from 0 = no interference to 10 = unable to
carry on any activities.
Participants
The 73 participants randomized ranged from 23 to 86 years old (mean = 58.0, standard deviation
[SD] = 12.8 years), and 27.6% were 65 or older. Most were women (68.5%) and white British (97.3%).
Most were married or living with a partner (65.7%); 12.3% were unmarried, 11.0% divorced, 11.0%
widowed. They had completed a mean of 12.4 years of education (SD = 4.2). The median pain duration
was 10.0 years, range 1.5–50.0 years. The primary locations of pain included low back (37.0%); lower
extremity (23.3%); neck (15.1%); all over (13.7%); or other (10.9%). Participants reported wide-ranging
and mostly multiple pain-related diagnoses. The most frequently mentioned diagnosis was fibromyalgia
(32.0%). Only 9.6% were working full time outside the home. The largest proportion of participants
(31.0%) was not working because of pain, and another 8.2% were working part time because of pain. The
remaining participants were retired (27.4%); working as homemakers (16.4%); or other (7.4%). At the
initial screening phase, all participants completed a measure of medical comorbidities, including 13 health
conditions.25 Excluding back pain from the list, 80.9% of participants reported at least 1 of these; 38.2%
reported 2 or more; and 17.6% reported 3 or more. The most commonly reported conditions included
osteoarthritis (30.6%); depression (40.3%); and hypertension (30.6%).
Treatment Outcome and Process Measures

The baseline, posttreatment, and follow-up measures included the key domains of patient functioning
deemed appropriate for chronic pain treatment trials,26 are well validated and standardized, and are
frequently used in other treatment studies.3 All measures were administered and returned through the mail.
Participants who did not initially return completed measures were contacted once by mail and once by
telephone to encourage them to provide their data.
Primary clinical outcome measures included the disability score from the Roland and Morris Disability
Questionnaire,24 depression severity from the Patient Health Questionnaire–9,13 the physical functioning
score of the Short Form Health Survey (SF-36),33 and a 0 to 10 numerical rating of average pain intensity
in the past week.
Secondary outcome measures included the emotional functioning score from the SF-36; a patient global
impression of change (PGIC) score, a 7-point numerical rating from 1 = very much improved to 7 = very
much worse5; and a question about changes in medication, administered at posttreatment and follow-up
only. Health care visits for pain were also tracked through patient report, including GP visits, other visits to
physicians, and accident and emergency visits during the previous 3-month period. These items were
administered before treatment and at follow-up only.
Treatment process measures included a measure of pain acceptance, the 20-item Chronic Pain Acceptance
Questionnaire,19 and a measure of general psychological acceptance, the 7-item Acceptance Action
Questionnaire II.1 The Chronic Pain Acceptance Questionnaire assesses the capacity to engage in activities
that include pain without struggling with the pain. The Acceptance Action Questionnaire II assesses
processes of avoidance or being blocked in functioning from unwanted psychological experiences. When
the items are reversed for scoring, they are considered a reflection of general psychological acceptance.
Treatment
The group treatment program was an adaptation of ACT principles and treatment methods for chronic
pain.7,15 The format, setting, and scheduling were designed with local input from people with chronic
pain, from GPs and practice nurses, and from health care commissioners, based on group discussion and a
combination of qualitative and quantitative analyses.32 The treatment includes a combination of methods
to promote psychological flexibility, including acceptance, cognitive defusion, and values-based and
committed action. It emphasizes experience-based methods, metaphor, and exposure and de-emphasizes
lecturing and information-giving. Before the start of treatment, all participants were telephoned by the
treatment provider for a very brief introduction and to begin to build some rapport. Treatment was
provided by 1 of 2 trained clinical psychologists (L.M.M. and another), each with more than 5 years of
experience in treatment for chronic pain and ACT. The format of treatment included 4 sessions, each 4
hours long, delivered 3 sessions one week and 1 session a week later. The content of the treatment was
designed so that all of the primary treatment processes were introduced during the first 3 sessions and
session 4 was focused on review and further enhancing the processes. Hence, any participant attending at
least 3 sessions was considered to have had exposure to all of the key processes. The actual allocated
group sizes at the 3 separate locations were the treatment was provided were 12, 12, and 13 participants.
All sessions were conducted during afternoon hours in GP practices that were local to the participants.
Treatment consistency and fidelity were maintained by use of a treatment manual, and all sessions were
audiotaped for later analysis (not reported here).
Treatment as Usual
Participants in the control arm were asked to follow their usual treatments, including any new treatments
their GP or their other doctors might wish, during their time in the study. Medication changes and medical
visits were then assessed at follow-up.
Analyses
Initial data analyses examined the participants in the 2 treatment conditions for baseline differences on
background, treatment outcome, and treatment process variables. Then a series of analyses of covariance
were calculated, with the outcome and process variables at posttreatment and follow-up as the dependent
variables and the baseline values as covariates. To assess whether there was some influence tied to the 3
varying locations where recruitment and treatment were done, the location of treatment (and therefore
treatment groups) was included as a factor to test whether there was such an effect in the data. Following
the significance tests, for each of the mean comparisons at posttreatment and follow-up, between-group
effect sizes, Cohen's d, were calculated based on posttreatment and follow-up means and pooled SDs.
Group outcome differences in the categorical PGIC and medication use variables were examined with chi-
square. The clinical outcome and process measures were analyzed in 3 separate ways. First, all available
data were submitted to the between-group analyses, regardless of number of treatment sessions attended.
Next, an intention-to-treat (ITT) approach to these same analyses was used with imputation of missing
data by last value carried forward. Finally, only those who were regarded as receiving a full treatment
experience were compared, again, to the control condition. All significance tests were 2-tailed and alpha
was set at P < .05, given the pilot nature of this project.
Results
Attendance and Data Adherence

Thirty-three (89.2%) of the 37 participants allocated to the ACT condition attended at least 1 session.
Those who did not attend treatment were unable to do so because of illness (n = 2); another obligation
(n = 1); or unknown (n = 1). Twenty-seven participants (72.9%) attended 3 or 4 sessions and were
regarded as having a complete treatment experience. Eighteen participants (48.6% of those allocated to
ACT) attended all 4 sessions of ACT. Thirty-one (83.8% of the 37 participants allocated to ACT) provided
data at posttreatment, and 28 (75.7% of those allocated) provided data at follow-up. In the TAU condition,
27 participants (75.0% of those allocated to TAU) provided data conjointly with the completion of the
ACT treatment, and 28 (77.7%) provided data at the 3-month follow-up.
Preliminary Analyses
Comparisons using independent groups t-tests of those who provided outcome data showed that the ACT
and TAU conditions did not differ on age, education, duration of pain, number of comorbid medical
conditions, number of physicians seen in the past due to their pain, or number of times they had seen their
GP for pain in the past 3 months, as assessed at baseline. They also did not differ on baseline disability,
depression, physical or emotional functioning from the SF-36, acceptance of pain, or psychological
acceptance, all P > .05.
Analyses of the group and location effect, across the 14 posttreatment and follow-up analyses involving
mean comparisons, revealed 2 significant interactions of the treatment condition effect and this location
effect. One of these involved immediate posttreatment disability, F(2, 50) = 3.57, P = .036, and the other
involved depression at follow-up, F(2, 48) = 3.31, P = .045. In the first case, inspection of the data showed
that 1 of the locations yielded both a relatively high disability score in the TAU group and a relatively low
score for the ACT group at posttreatment. The direction of differences between the TAU versus ACT
conditions did not differ across locations, nor did the magnitude of posttreatment disability scores across
the 3 ACT groups, F(2, 28) = 1.71, P = .20. An analogous situation was observed for the depression result
at follow-up but for a separate group/location. Once again, no difference between the ACT groups on
depression at follow-up was observed, F(2, 28) = .03, P = .97. Because these were unsystematic, minority
issues, and possibly spurious, it was elected to conduct all subsequent analyses with the combined ACT
treatment group data.
Posttreatment Outcome Results

Table 1 includes means, SDs, analysis of covariance results, and effect sizes from posttreatment and
follow-up. Immediately post treatment, there were significant group differences in favor of ACT for
depression but no significant changes for disability, physical functioning as measured by the SF-36, or
pain. The effect sizes for depression was small, d = .46. In terms of secondary outcomes, there was a
significant posttreatment effect on PGIC, with 53.3% of those in the ACT condition reporting overall
improvement whereas in the TAU group the number was 25.0%. There was no significant group difference
on emotional functioning from the SF-36. Most patients' pain medication stayed the same in both groups
during the treatment interval. One participant in the TAU condition and 3 in the ACT condition reported a
decrease in their medication. Six participants in the TAU condition and 4 in the ACT condition reported
increases. The difference between groups was not significant.
Follow-Up Outcome Results

At the 3-month follow-up, there were significant treatment group differences in outcome in favor of ACT
for disability and depression. There were no significant group differences for the measures of physical
functioning or pain. The effects at follow-up for disability, d = .59, and depression, d = .58, were medium.
There remained roughly twice as many participants in the ACT condition compared to the TAU condition
who rated themselves as improved at follow-up; however, this effect marginally missed statistical
significance, P = .064. Once again, as at posttreatment, there were no significant group differences in the
emotional functioning score from the SF-36 or in pain medication changes.
Treatment Process Results
Contrary to predictions, there were no significant group differences in either acceptance of pain or general
psychological acceptance immediately at the completion of the 2-week ACT treatment phase. The
difference in acceptance of pain marginally missed significance, P = .063. At follow-up, there remained no
significant group difference for general psychological acceptance; however, the group difference in
acceptance of pain at this point did reach significance and the effect size was medium, d = .64.
ITT Analyses
Using the last-value-carried-forward method for imputing missing values, ITT analyses on all of those
randomized to either ACT or TAU showed a significant effect immediately post treatment for disability,
F(1, 70) = 4.43, P < .05, d = .36; depression, F(1, 70) = 5.91, P < .05, d = .46; and marginally significant
effects for acceptance of pain, F(1, 70) = 3.91, P = .05, d = .23; and emotional functioning, F(1, 70) = 3.93,
P = .05, d = .69. There were no significant effects immediately following treatment for physical
functioning, pain, or general psychological acceptance. At follow-up, there was a marginal effect for
disability, F(1, 70) = 3.38. P = .07, d = .37, but no significant effects for depression, physical functioning,
pain, acceptance of pain, general acceptance, or emotional functioning.
Treatment Completer Analyses

There were 27 participants of those who were allocated to ACT who attended 3 or 4 sessions, 6 who
attended 1 or 2 sessions, and 4 who attended none. Three sessions was regarded as the minimum number
for being regarded as having completed treatment. Based on analysis of covariance, comparing these
treatment completers with the TAU condition, there were significant effects in favor of ACT immediately
post treatment for disability, F(1, 49) = 8.39, P < .01, d = .45; depression, F(1, 49) = 8.72, P < .01, d = .53;
acceptance of pain, F(1, 49) = 4.59, P < .05, d = .51; and emotional functioning, F(1, 49) = 4.07, P < .05,
d = .71. There were no significant effects immediately post treatment for physical functioning, pain, or
general acceptance. At follow-up, there were significant effects for disability, F(1, 51) = 5.43, P < .05,
d = .55; depression, F(1, 50) = 5.82, P < .05, d = .59; and acceptance of pain, F(1, 48) = 4.87, P < .05,
d = .59. There were no significant effects at follow-up for physical functioning, pain, general acceptance,
or emotional functioning.
In the completer analyses, as in the analyses of all those providing data, global ratings of improvement
immediately following treatment again significantly favored the ACT condition, χ2(1, n = 48) = 4.87,
P < .05. Global ratings of improvement at follow-up did not show a significant difference, P = .067.
Additional Post Hoc Analyses

In general, there was not a high rate of health care use in the treatment groups during 3-month period
before the start of treatment and at follow-up. The modal number of GP visits was 1 and the modal number
of other doctor and accident and emergency visits was zero in both groups at both time points. At follow-
up, there were just 20.4% of participants who saw their GP more than 2 times. Eight of these 11 people
(72.5%) reported 3 or 4 visits, 1 reported 5 visits, and 2 reported weekly visits, a pattern that had carried
on from pretreatment. There were no significant follow-up differences between the treatment conditions in
GP visits, other doctor visits, accident and emergency visits, or total visits during the 3-month follow-up
interval, all t < 1.67, all P > .10.
Discussion
The current study was developed as a pilot RCT of ACT in comparison to treatment as usual for chronic
pain in a general practice setting in the United Kingdom. The setting, recruitment strategy, and the brief
treatment format had not been previously tested and the present study was designed to see if an RCT could
be conducted with these elements. In this trial, we demonstrated successful recruitment of the targeted
number of participants, greater than 60, in a short period of 2 months at each of 3 locations; 73% in the
ACT condition were regarded as having received the complete treatment, and more than 75% of the total
sample randomized were retained at follow-up.
Power calculations were not done nor were formal predictions of significant treatment effects made during
the design of this study. With this proviso in mind the ACT condition did produce a number of significant
treatment effects compared to the TAU condition, on depression and patient-rated improvement at
posttreatment and on disability, depression, and pain acceptance at the 3-month follow-up. Effect sizes for
the significant effects were small for depression immediately post treatment, and medium for disability,
depression, and acceptance of pain at follow-up.
Analyses done on an ITT basis or focused only on those who were regarded as completing treatment
provide distinctly differing views of the trial results. The ITT analyses showed significant effects in favor
of ACT for disability and depression but only nonsignificant marginal effects for acceptance of pain and
emotional functioning. Only a marginal nonsignificant effect for disability remained at follow-up.
Analyses excluding participants who missed 2 or more of the 4 sessions, so-called completer analyses,
showed more positive results, including significantly better results for the ACT condition in comparison to
the TAU condition on disability, depression, pain acceptance, and emotional functioning at posttreatment,
and disability, depression, and pain acceptance at follow-up. Significant between-group effect sizes were
small to medium at posttreatment and medium at follow-up. It should be clarified that the sample size of
this RCT is small compared to trials designed to produce more definitive results.14 These results ought to
be seen as preliminary. The positive results from the completer analyses compared to ITT particularly call
for further investigation of the variables that identify who completes and who does not complete treatment,
how to improve engagement, and whether it is possible to identify those who achieve poor results
regardless.
There are a number of other preliminary RCTs of ACT for chronic pain,2,27,35,36 and at least 1 larger
trial comparing ACT to more traditional CBT (N = 114).34 There are also nonrandomized, partly
controlled, or pilot studies,10,20,31 a reanalysis of treatment outcome focused on older adults,17 and
several effectiveness studies,16,29 including 1 showing good outcomes at 3 years posttreatment.30 The
present study is consistent with the previous ones in providing support for ACT and in providing a basis
for more ambitious or more focused studies. It differed from the earlier studies in that it was conducted
exclusively within primary care in the United Kingdom, with very liberal inclusion criteria, with no face-
to-face assessment or screening, and unlike some of the earlier RCTs it included group delivery. It was also
significantly briefer in the number of sessions and in total treatment hours compared with some previous
group-based treatments, particularly those conducted in the United Kingdom.16,20
It may appear unnecessary to conduct or present more preliminary trials of ACT. However, the planning
and application for funding the current study began in 2008, a time when there were significantly fewer
publishes studies. Certainly the unique features in the design of the current treatment represent, including
its base in UK primary care, its 4-session format, and its minimal screening, provide a way to examine the
robustness and generality of the treatment model.
There are some inconsistencies in our current results that may provide a basis for improvement in later
trials. Unexpectedly, participants in the TAU condition demonstrated increases in disability and depression,
especially at follow-up. These changes contribute to the observed between-group effects on these
outcomes. Perhaps even more unexpectedly, they also demonstrated a remarkable increase in acceptance of
pain, a change that reduced the between-group effect. The posttreatment effect on acceptance of pain was
small. This is inconsistent with our previous studies, where effects on acceptance of pain were large and
among the largest achieved in comparison to other outcome and process variables.16,29 Likewise, we
produced only small nonsignificant effects on our measure of general psychological acceptance, among the
smallest of all those observed, and small or inconsistent effects on the physical and emotional functioning
scales of the SF-36. In future studies, with treatment formats similar to the one used here, treatment
providers may need to intensify the methods applied to pain-related and psychological acceptance or
devote more time to these.
The sample of participants encountered in this study was more chronic, more complex, and more diverse
than expected. There were highly disabled participants who had failed previous psychological treatments
with a higher intensity than the treatment provided here. It is clear that the SF-36 scales in particular
produced highly variable scores. There were some participants with extremely limited mobility—2
participants attended in wheelchairs. In the future, it may improve the outcome of trials of a similar
treatment format to narrow the range of disability among the participants, add a physical rehabilitation
piece to the psychology treatment methods for those with higher physical disability, and perhaps to screen
out those who had already failed higher-intensity treatments of a similar type. A screening visit with a
treatment provider, rather than solely paper-based screening as done here, could certainly help to screen
out some cases where there is a high likelihood that the treatment will not meet their needs. This is normal
in actual clinical practice. Finally, there were engagement challenges, particularly in the 27% of
participants in the ACT condition who did not participate in a full treatment experience. This trial was not
resourced to address engagement as is sometimes done in specialty treatment centers, such as with
additional one-to-one sessions with some participants. On the other hand, this treatment was designed for
high accessibility and for efficient delivery, and this was achieved, albeit with the result that some
individuals may have received less than optimal results.
In previous results from this same sample, it was shown that participants in the ACT groups found the
treatment credible and found participating in the study acceptable.18 It was also found that some
participants experienced greater pain or fatigue, or found the sessions too lengthy. Even though this was
not the majority, it was nonetheless a significant minority. This is somewhat a conundrum as ACT actually
operates by including unwanted psychological experiences in treatment delivery so that the ways that these
can create barriers to daily functioning can be examined directly and so that new patterns of behavior can
be shaped and rehearsed in the context of treatment. Certainly the group delivery mode and the limited
one-to-one relationship between the therapist and each participant place some limits on how a treatment
provider can reverse avoidance patterns that occur in treatment sessions, and seek to loosen the grip of
thoughts and beliefs that participants hold tightly. Finally, even though we attempted to ease the burden of
participation by designing a 4-session treatment, the 4-hour session length and the total treatment time
remain a considerable burden and certainly will not suit some people's circumstances. These are challenges
for continuing treatment development.
The present study obviously has a number of limitations both as a pilot and especially as a test of ACT.
First, it is no more than a pilot for a pragmatic trial, as there was no active treatment comparison condition.
This type of design does not allow specific statements about the efficacy of ACT. The region of the
country and the specific GP practices involved represent a selected sample, and it is not clear that similar
results will be obtained in other regions and other practices. The clinical outcome results for disability and
depression were not echoed in effects on physical and emotional functioning. Even given the limited
statistical power here, this means that either the treatment is failing in some specific way or the SF-36 is
not sensitive to specific treatment results. We did learn that some of the participants struggled with the
wording in some of the items of the SF-36, particularly the distance implied by a “block,” a concept not
commonly used in the United Kingdom, and the notion of “full of pep.” In the future, a change in this
measure or in the treatment is advisable. Finally, as a small RCT without registered trial unit support, it
was not powered for a definitive result and certainly there are potential sources of bias that are
uncontrolled. Although data were gathered and entered blind and analyses were supervised by a statistician
(G.J.T.), they were not all conducted blind to treatment condition, for example.
In summary, further larger-scale trials of ACT for chronic pain, such as in primary care and in the United
Kingdom, appear feasible and are recommended, with a few adjustments from the methods used here.
Significant treatment effects for disability, depression, and pain acceptance may be achievable, including
perhaps medium-sized effects after a short follow-up interval of 3 months. We hypothesize that a number
of factors may have reduced treatment impact, and perhaps greater attention to these can be incorporated in
future trials. It seems possible, based on comparisons with previous results, that 1 or more of the following
modifications could improve outcomes: intensifying the methods to produce results on acceptance,
especially general psychological acceptance; recruiting a more homogeneous sample in their current
functioning; excluding those who failed previous treatments; including a face-to-face assessment prior to
the start of treatment; including a physical exercise component; and/or allowing one-to-one sessions for
patients with engagement difficulties.
Acknowledgments
This paper presents independent research funded by the National Institute for Health Research (NIHR)
under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0808-16156).
The views expressed are those of the author(s) and not necessarily those of the National Health Service,
the NIHR or the Department of Health. The authors thank Dr Miles Thompson for his help during
treatment delivery on this project.
Footnotes
This research was funded by the UK National Institute for Health Research (NIHR) under its Research for Patient
Benefit (RfPB) Programme.
The authors report no conflict of interests.
References
1. Bond F.W., Hayes S.C., Baer R.A., Carpenter K.C., Guenole N., Orcutt H.K., Waltz T., Zettle R.D.
Preliminary psychometric properties of the Acceptance and Action Questionnaire–II: A revised measure of
psychological flexibility and acceptance. Behav Ther. 2011;42:676–688. [PubMed: 22035996]
2. Dahl J., Wilson K.G., Nilsson A. Acceptance and commitment therapy and the treatment of persons at
risk for long-term disability resulting from stress and pain symptoms: A preliminary randomized trial.
Behav Ther. 2004;35:785–801.
3. Dworkin R.H., Turk D.C., Farrar J.T., Haythornthwaite J.A., Jensen M.P., Katz N.P., Kerns R.D., Stucki
G., Allen R.R., Bellamy N., Carr D.B., Chandler J., Cowan P., Dionne R., Galer B.S., Hertz S., Jadad A.R.,
Kramer L.D., Manning D.C., Martin S., McCormick C.G., McDermott M.P., McGrath P., Quessy S.,
Rappaport B.A., Robbins W., Robinson J.P., Rothmar M., Royal M.A., Simon L., Stauffer J.W., Stein W.,
Tollett J., Wernicke J., Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT
recommendations. Pain. 2005;113:9–19. [PubMed: 15621359]
4. Eccleston C., Williams A.C., Morley S. Psychological therapies for the management of chronic pain
(excluding headache) in adults (Review) Cochrane Database Syst Rev. 2009;(2):CD007407. [PubMed:
19370688]
5. Guy W. US Government Printing Office; Washington, DC: 1976. ECDEU Assessment Manual for
Psychopharmacology (DHEW Publication No. ADM 76-338)
6. Hayes S.C., Luoma J.B., Bond F.W., Masuda A., Lillis J. Acceptance and commitment therapy: Model,
processes, and outcomes. Behav Res Ther. 2006;44:1–25. [PubMed: 16300724]
7. Hayes S.C., Strosahl K., Wilson K.G. Guildford Press; New York: 1999. Acceptance and Commitment
Therapy: An Experiential Approach to Behavior Change.
8. Hayes S.C., Strosahl K.D., Wilson K.G. Guilford Press; London: 2012. Acceptance and Commitment
Therapy: The Process and Practice of Mindful Change.
9. Jensen M.P. Psychosocial approaches to pain management: An organizational framework. Pain.

2011;152:717–725. [PubMed: 21168972]
10. Johnson M., Foster M., Shennan J., Starkey N.J., Johnson A. The effectiveness of an acceptance and
commitment therapy self-help intervention for chronic pain. Clin J Pain. 2010;26:393–402. [PubMed:
20473046]
11. Keefe F.J., Rumble M.E., Scipio C.D., Giordano L.A., Perri L.M. Psychological aspects of persistent
pain: Current state of the science. J Pain. 2004;5:195–211. [PubMed: 15162342]
12. Kerns Rd, Sellinger J., Goodin B.R. Psychological treatment of chronic pain. Annu Rev Clin Psychol.
2011;7:411–434. [PubMed: 21128783]
13. Kroenke K., Spitzer R.L., Williams J.B.W. The PHQ-9. Validity of a brief depression severity measure.
J Gen Intern Med. 2001;16:606–613. [PMCID: PMC1495268] [PubMed: 11556941]
14. Lamb S.E., Lall R., Hansen Z., Castelnuovo E., Withers E.J., Nichols V., Griffiths F., Potter R.,
Szczepura A., Underwood M. A multicentred randomized controlled trial of a primary care-based
cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health
Technol Asssess. 2010;14:1–253. [PubMed: 20807469]
15. McCracken L.M. IASP Press; Seattle, WA: 2005. Contextual Cognitive-Behavioral Therapy for
Chronic Pain.
16. McCracken L.M., Gutiérrez-Martínez O. Processes of change in psychological flexibility in an

interdisciplinary group-based treatment for chronic pain based on acceptance and commitment therapy.
Behav Res Ther. 2011;49:267–274. [PubMed: 21377652]
17. McCracken L.M., Jones R. Treatment for chronic pain for adults in the seventh and eighth decades of
life: A preliminary study of acceptance and commitment therapy (ACT) Pain Med. 2012;13:861–867.
[PubMed: 22680627]
18. McCracken L.M., Sato A., Wainwright D., House W., Taylor G.J. A feasibility study of brief group-
based acceptance and commitment therapy (ACT) for chronic pain in general practice: Recruitment,
attendance, and patient views. Prim Health Care Res Dev. 2013:1–12. [PubMed: 23866920]
19. McCracken L.M., Vowles K.E., Eccleston C. Acceptance of chronic pain: Component analysis and a
revised assessment method. Pain. 2004;107:159–166. [PubMed: 14715402]
20. McCracken L.M., Vowles K.E., Eccleston C. Acceptance-based treatment for persons with complex
longstanding chronic pain: A preliminary analysis of treatment outcome in comparison to a waiting phase.
Behav Res Ther. 2005;43:1335–1346. [PubMed: 16086984]
21. Morley S. Efficacy and effectiveness of cognitive behaviour therapy for chronic pain: Progress and
some challenges. Pain. 2011;152:S99–S106. [PubMed: 21159433]
22. Morley S., Eccleston C., Williams A. Systematic review and meta-analysis of randomized controlled
trials of cognitive behaviour therapy and behaviour therapy for chronic pain in adults, excluding headache.
Pain. 1999;80:1–13. [PubMed: 10204712]
23. Morley S., Keefe F.J. Getting a handle on process and change in CBT for chronic pain. Pain.
2007;127:197–198. [PubMed: 17182182]
24. Roland M., Morris R. A study of the natural history of back pain. Part I. Development of a reliable and
sensitive measure of disability in low-back pain. Spine. 1983;8:141–144. [PubMed: 6222486]
25. Sangha O., Stucki G., Liang M.H., Fossel A.H., Katz J.N. The self-administered comorbidity
questionnaire: A new method to assess comorbidity for clinical and health services research. Arthritis
Rheum (Arthritis Care Res) 2003;49:156–163. [PubMed: 12687505]
26. Turk D.C., Dworkin R.H., Allen R.R., Bellamy N., Brandenburgh N., Car D.B., Cleeland C., Dionne
R., Farrar J.T., Galer B.S., Hewitt D.J., Jadad A., Katz N.P., Kramer L.D., Manning D.C., McCormick
C.G., McDermott M., McGrath P., Quessy S., Rappaport B.A., Robinson J.P., Royal M.A., Simon L.,
Stauffer J.W., Stein W., Tollett J., Witter J. Core outcome domains for chronic pain clinical trials:
IMMPACT recommendations. Pain. 2003;106:337–345. [PubMed: 14659516]
27. Thorsell J., Finnes A., Dahl J., Lundgren T., Gybrant M., Gordh T., Buhrman M. A comparative study
of 2 manual-based self-help interventions, acceptance and commitment therapy and applied relaxation, for
persons with chronic pain. Clin J Pain. 2011;27:716–723. [PubMed: 21540740]
28. Von Korff M., Ormel J., Keefe F.J., Dworkin S.F. Grading the severity of chronic pain. Pain.
1992;50:133–149. [PubMed: 1408309]
29. Vowles K.E., McCracken L.M. Acceptance and values-based action in chronic pain: A study of
treatment effectiveness and process. J Consult Clin Psychol. 2008;76:397–407. [PubMed: 18540733]
30. Vowles K.E., McCracken L.M., Zhao-O'Brien J. Acceptance and values-based action in chronic pain:
A three year follow-up analysis of treatment effectiveness and process. Behav Res Ther. 2011;49:748–755.
[PubMed: 21885034]
31. Vowles K.E., Wetherell J.L., Sorrett J.T. Targetting acceptance, mindfulness, and values-based action
in chronic pain: Findings of two preliminary trials of an outpatient group-based intervention. Cogn Behav
Prac. 2009;16:49–58.
32. Wainwright D., Boichat C., McCracken L. Using the nominal group technique to engage people with
chronic pain in health service development. Int J Health Plann Manage. 2013 [PubMed: 23319399]
33. Ware J.E., Sherbourne C.D. The MOS 36-item Short-Form Health Survey (SF-36) Med Care.
1992;30:473–483. [PubMed: 1593914]
34. Wetherell J.L., Afari N., Rutledge T., Sorrell J.T., Stoddard J.A., Petkus A.J., Solomon B.C., Lehman
D.H., Liu L., Lang A.J., Atkinson J.H. A randomized, controlled trial of acceptance and commitment
therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011;152:2098–2107. [PubMed:
21683527]
35. Wicksell R.K., Ahlqvist J., Bring A., Melin L., Olsson G. Can exposure and acceptance strategies
improve functioning and life satisfaction in people with chronic pain and whiplash-associated disorders
(WAD)? A randomized controlled trial. Cogn Behav Ther. 2008;37:169–182. [PubMed: 18608312]
36. Wicksell R.K., Kemani M., Jensen K., Kosek E., Kadetoff D., Sorjonen K., Ingvar M., Olsson G.L.
Acceptance and commitment therapy for fibromyalgia: A randomized controlled trial. Eur J Pain.
2012;17:599–611. [PubMed: 23090719]
37. Williams A.C.D.C., Eccleston C., Morley S. Psychological therapies for the management of chronic
pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012;11:CD007407.
[PMCID: PMC6483325] [PubMed: 23152245]
Figures and Tables
Figure 1
Open in a separate window

CONSORT flow diagram. *One participant in the TAU condition was uncontactable at posttreatment but contactable at
follow-up.
Table 1
Results Including All Those Providing Data (n = 58 at Posttreatment, n = 54 at 3-Month Follow-
Up)
GROUP MEAN (SD) BETWEEN-GROUP BETWEEN-G

ANCOVA: F SIZ
PRETREATMENT POSTTREATMENT FOLLOW- POSTTREATMENT FOLLOW- POSTTREATME

UP UP
Primary outcomes measures
∗
Disability ACT 12.23 (4.53) 9.96 (4.85) 10.82 3.16 6.10 .32
(5.55)
TAU 12.19 (4.84) 12.58 (6.02) 14.14
(5.19)
∗ ∗
Depression ACT 11.58 (5.81) 9.53 (6.84) 9.95 5.60 4.45 .46
(7.01)
TAU 12.44 (7.03) 13.04 (8.31) 14.08
(6.68)
Physical ACT 30.35 (22.16) 31.13 (19.99) 31.51 <1 1.60 .17
functioning (23.28)
TAU 29.18 (27.76) 27.32 (24.44) 22.61
(21.19)
Pain ACT 6.51 (1.92) 6.45 (1.92) 6.54 1.41 <1 .44
(2.10)
TAU 7.00 (1.64) 7.27 (1.73) 7.19
(2.03)
Treatment process measures
∗
Pain ACT 54.87 (14.39) 64.97 (15.13) 71.11 3.60 5.83 .26
acceptance (8.86)
TAU 56.92 (16.14) 54.92 (17.04) 64.89
(11.72)
Psychological ACT 23.83 (10.77) 23.60 (11.16) 23.19 <1 <1 .20
acceptance (12.00)
TAU 24.72 (9.81) 25.77 (10.75) 25.55
(9.55)
Secondary outcomes
Emotional ACT 52.02 (25.43) 65.55 (16.93) 64.21 3.70 1.08 .68
functioning (21.84)
Open in a separate window
Abbreviation: ANCOVA, analysis of covariance.
NOTE. Disability was measured with the Roland and Morris Disability Questionnaire, depression with the Patient
Health Questionnaire–9, pain with a 0 to 10 scale of average pain in the past week, physical and emotional
functioning with the SF-36, pain acceptance with the Chronic Pain Acceptance Questionnaire, psychological
acceptance with the Acceptance and Action Questionnaire–II, rating of change with the 1 to 7 Patient Global
Impression of Change scale, and medication reduction with a single self-report item asking whether medication was
increased, decreased, or stayed the same. Because of missing data, the actual n in the ACT condition varies from 28
to 31 and in the control condition from 26 to 27, including both posttreatment and follow-up time points.
∗
P < .05. d > .20, small; >.50, medium; >.80, large.

A Trial of A Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) For Chronic Pain in General Practice - Pilot Outcome and Process Results

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

A Trial of A Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) For Chronic Pain in General Practice - Pilot Outcome and Process Results

Uploaded by

Copyright:

Available Formats

3/4/2020 A Trial of a Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) for Chronic Pain in General Practice:

actice: Pilot Outco…

A Trial of a Brief Group-Based Form of Acceptance and Commitment

Lance M. McCracken: Lance.McCracken@kcl.ac.uk

Copyright © 2013 Elsevier Inc.

This document may be redistributed and reused, subject to certain conditions.

Treatment Outcome and Process Measures

Attendance and Data Adherence

Posttreatment Outcome Results

Follow-Up Outcome Results

Treatment Process Results

Treatment Completer Analyses

Additional Post Hoc Analyses

The authors report no conflict of interests.

9. Jensen M.P. Psychosocial approaches to pain management: An organizational framework. Pain.

16. McCracken L.M., Gutiérrez-Martínez O. Processes of change in psychological flexibility in an

Figures and Tables

Open in a separate window

GROUP MEAN (SD) BETWEEN-GROUP BETWEEN-G

PRETREATMENT POSTTREATMENT FOLLOW- POSTTREATMENT FOLLOW- POSTTREATME

Open in a separate window

Abbreviation: ANCOVA, analysis of covariance.

You might also like