Managing Chronic Pain Through Self-Help: A Randomized Controlled Trial Comparing Guided Self-Help Programs Based on Acceptance and Commitment Therapy (ACT) to Education
Phase: NA
Conditions: Chronic Pain
Sponsor: Université du Québec à Trois-Rivières

 
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Managing Chronic Pain Through the Web:  
Evaluating the Efficacy of a Web-based Acceptance and Commitment Therapy (ACT) 
Intervention   
 
 
 
 
 
 
 
 
 
 
 
 
2018-10-15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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One in five Canadians currently lives with chronic pain (CP; Reitsma et al., 2011) and the prevalence is 
expected to increase 70% by 2025 due to the aging population (Schopflocher, 2003). The daily 
experience of pain is often accompanied by important psychosocial changes. For example, CP has been 
associated with the onset of anxiety and depressive disorders (Gerrits et al., 2014) as well as feelings of 
anger and injustice (Scott et al., 2013). Research has also shown that a person with CP is twice more 
likely to commit suicide than a person without CP (Tang & Crane, 2006), which demonstrates the extent 
of suffering that people with this condition can experience.  
At present, access to treatment for CP in Canada is limited (Lynch et al., 2011) and is considered a major 
challenge. For example, the average wait-list time for access to care is over a year in more than one third 
of publicly funded centres for pain and some could even go up to five years (Lynch et al., 2011; Peng et 
al., 2007). Furthermore, many areas of the country do not have interdisciplinary pain management 
centres (Lynch et al., 2011). Yet, access to pain management is a fundamental human right as stated in 
the Declaration of Montreal (Brennan et al., 2007; IASP, 2017). In addition to challenges associated to 
access to treatment for pain, medical/physical treatments are often not entirely effective in reducing one's 
pain when it is chronic. For example, only 30% of people who take pain-relief medication would see an 
improvement in their condition, while 70% of people continue to experience pain on a daily basis (Stahl, 
2013).  
Acceptance and Commitment Therapy ("ACT"; Hayes et al., 2012) is an empirically supported treatment 
with "strong research support" for CP by the American Psychological Association (APA, 2013). The 
experience of injustice has recently been conceptualized within the ACT psychological flexibility model 
(Scott et al., 2013b). ACT has been shown to help improve functioning and quality of life despite pain, 
and could potentially help mitigate the impact of perceived injustice on adverse pain outcomes (e.g. 
disability, depressive symptoms). Given the evidence of the effectiveness of ACT with CP, there are 
increasing efforts to improve the accessibility of this type of treatment. In particular, internet-delivered 
versions of ACT for CP are promising because they offer a cost-effective treatment option that usually 
requires little support from a therapist, and can be widely accessed.  
Despite promising results (Bring, Åsenlöf, & Söderlund, 2016; Trompetter et al., 2016), further studies 
are needed to evaluate the effects of self-help interventions like ACT, including on physical and emotional 
functioning (Brown et al., 2016, Eccleston et al., 2014). Given the recent nature of self-help interventions 
in a population with chronic pain, other studies need to support their effectiveness. In addition, there are 
no studies that compared a self-help Web-based ACT intervention to a bibliotherapy intervention (French, 
Golijani-Moghaddam, & Schröder, 2017). 
 
Objectives: 
Evaluate the effectiveness and change processes of a web-based intervention program with minimal 
therapeutic contact, compared to a bibliotherapy and an education program based on brochures in adults 
with suffering of chronic pain. 
 
Hypothesis 1: It is expected that the web-based self-help intervention generates a significant reduction 
in pain-related disability greater than the control group (education). 

 
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Hypothesis 2: It is expected that the bibliotherapy self-help intervention by bibliotherapy will result in a 
significant reduction in pain-related disability (primary variable) greater than the control group 
(education). 
Hypothesis 3: It is expected that a web-based intervention will be associated with a greater reduction 
in pain-related disability (the primary variable) than bibliotherapy. 
Hypothesis 4: It is expected that self-help Web-based interventions will lead to a significant 
improvement in the quality of life above the control (education) group. 
Hypothesis 5: It is expected that bibliotherapy will significantly improved the quality of life superior to 
the control group (education). 
Hypothesis 6: Self-help interventions are expected to result in a significant reduction in anxiety and 
depressive symptoms compared to the control (education) group. 
Hypothesis 7: Self-help interventions with bibliotherapy are expected to result in a significant reduction 
in anxiety-depressive symptoms compared to the control (education) group. 
Hypothesis 8: Results on primary (incapacity) and secondary variables (quality of life, anxiety-
depression) will remain at 3 and 6 months and will be superior to education brochure (control group). 
Hypothesis 9: The flexibility process is expected to be a mediator of change in the primary (disability) 
and secondary variables (quality of life, anode-depressive symptoms). 
Participants and procedure: Recruitment will be done in collaboration with the Quebec Association of 
Chronic Pain (AQDC), the Quebec Pain Research Network (RQRD), the Quebec Society of Fibromyalgia 
(SQF), Migraine Quebec, the Pain Clinics of Quebec. Quebec (28 including the CHUM, distribution of 
maps and billboards) and social networks Facebook (Facebook page with paid advertising). Participants 
will be notified of the study via email. If they have an interest in the study, they will click on a link that will 
take them to the information and consent form and will be asked questions about the inclusion criteria. 
 
 Be over 18 years old  Living in Quebec   
 Have a daily pain (greater than 4 out of 10) for more than three months that is not associated with 
cancer;  
 Have a reading and writing ability of French equivalent to a secondary 2;   
 Have Internet access at home and an email address;   
 Never have ACT-type psychotherapy or regular meditation in mindfulness, and have not read 
Frédérick Dionne's book "Liberez-vous de pain par meditation et ACT";   
 Have a stable medication for at least one month, if necessary.   
 Being emotionally stable 

 
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If they do not meet the criteria, they will be refer to a resource page and will be asked to leave their name 
as needed to be referred to relevant resources. If people meet the inclusion criteria, they will be asked to 
complete the pre-test questionnaires, which will confirm their participation in the study. 
 
Desis: A randomized control group trial with a sample of 300 presenting chronic pain, ie 100 persons for 
each experimental groups (web-based and bibliotherapy) and 100 persons for control group (education 
brochure). 
 
Arms:  
• 
Web-based, N = 100 
• 
Bibliotherapy, N = 100 
• 
Education brochure, N = 100 
 
The estimate includes four measurement times (before and after the intervention, and two times at follow 
up (after 3 and 6 months) to assess the impact of the intervention in the longer term. The proposal will 
include three conditions, a group receiving a self-help web-based intervention, a group receiving a book-
based intervention and a group receiving pain education brochures. Participants in all three groups 
receive 15-minute telephone calls from psychology students before and at week 3, a weekly email 
explaining the tasks to be completed, a discussion forum, access to an assistant to answer questions of 
a technical nature. These components aim to support participants' therapeutic approach and adherence 
to treatment (van Ballegooijen et al., 2014). Here is the content of the meetings for the 8 modules or 
weeks 
. 
Content of each module. 
 
Week 1 
 
Information about pain and ACT 
Week 2 
 
Values 
Week 3 
 
Learning to meditate 

 
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Week 4 
Committed action 
Week 5 
 
Willingness to have pain 
Week 6 
 
Defuse from thoughts 
Week 7 
 
Pacing 
Week 8 
 
Conclusion 
 
Instruments: All questionnaires will be self-administered online following an email sent. A hyperlink will 
automatically direct them to the UQTR Interactive Question Banking (IBQ) website. The completion 
time is evaluated between 25 and 30 minutes for each measurement period. 
 
Participants answered questions related to socio-demographic information such as their age, 
education, daily occupation, and annual income. Participants also answered a series of questions 
related to pain, such as the diagnosis of chronic pain and the use of pain relief medication. Notably, 
participants were asked to rate the average pain they experienced in the past week on a numerical 
rating scale ranging from 0 (no pain) to 10 (unbearable pain). According to previous research, this scale 
is a reliable measure of pain intensity 
 
Primary variable: 
BPI; Brief Pain Inventory (Interference Scale). This 10-item questionnaire evaluates the severity and 
interference of pain in daily activities. On a Likert scale ranging from 0 = does not interfere to 10 = 
interferes completely, participants are asked to rate the degree to which pain interfered with various 
activities in the past week (e.g., social activities, work, mood, etc.). A higher average score represents 
higher levels of pain interference on daily function. Internal coherence of this scale is good (α = 0,88).  
 
Secondary variables: 
Quality of life:  
 

 
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The World Health Organization Quality of Life-Brief (WHOQOL-BRIEF; WHOQOL; Group, 1998) is a self-
reported measure of 26 items assessing quality of life in terms of physical and psychological health, social 
relationships and social functioning. environment. This instrument has demonstrated good levels of 
internal consistency for its subscales (α = .66 to α = .80) and adequate test-retest reliability (r = .75). The 
French version of the instrument offers high consistency (Baumann, Erpelding, Régat, Collin, & Briançon, 
2010). 
 
Anxiety and depression:  
The Hospital Anxiety Depression Scale (HADS; Zigmond & Snaith, 1983; French version: Bocéréan & 
Dupret, 2014). This 14-item questionnaire evaluates psychological distress according to two 7-item 
subscale-measuring anxiety and depressive symptoms in non-psychiatric hospital contexts. Items are 
scored on a 4-point Likert scale ranging from 0 to 3. An example of items is “I feel tense or wound up. 
 
Process measures: 
Multidimensional Psychological Flexibility Inventory (24 items; MPFI). Psychological flexibility and 
inflexibility were measured with the French version of the MPFI-24 already described. This self-report 
questionnaire was developed by Rolffs, Rogge and Wilson (2016) and offers a response on a six-point 
Likert scale (Never / Always true). This tool has 12 distinct dimensions of flexibility or psychological 
influence (6 minutes). 
 
Chronic Pain Self-Efficacy Scale (FC-CPSES, 6 items). Self-efficacy is an important aspect to consider 
when evaluating the benefits of an intervention to improve self-management of chronic pain. This 
instrument has an internal consistency evaluated at more than α = 0.86. Better self-efficacy scores are 
associated with a better quality of psychological life, less severe pain symptoms and less dramatic 
tendencies (P <0.05), which supports the convergent validity of this tool (2 min). 
 
Chronic Pain Acceptance Questionnaire (CPAQ-8; McCracken, Vowles, & Eccleston, 2004; French 
version: Scott, Bernier, Garland, & Sullivan, 2003). The CPAQ-8 assesses a person’s acceptance of the 
experience of pain using two four-item subscales: activity engagement, which evaluates the degree to 
which behaviours are limited or restricted by pain, and pain willingness, which evaluates the degree or 
effort directed at controlling pain. Items are scored on a 7-point Likert scale ranging from 0 = never true 
to 6 = always true. An example of items is “I am getting on with the business of living no matter what my 
level of pain is.” Scores for the pain willingness subscale must be reversed before calculating a total 
score.  
 

 
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Questionnaire filled each week: 
 
Weekly journal (7 items): 
 
Participants will be invited to answer this short questionnaire before accessing the contents of the module 
for the week. It is an abbreviated tool with 3 items on a Likert type scale (0 = never, 6 = always) that 
assess flexibility processes (open, aware and active). In addition, to assess dependent variables 
throughout the process, 4 questions measuring disability, pain intensity, depression, and anxiety were 
added to the questionnaire. Thus, this questionnaire includes a total of 7 items designed to measure the 
evolution of the variables of interest over time, and the completion time is evaluated at 2 minutes. 
 
Follow up only: 
 
The Satisfaction Questionnaire (QS-8, Sabourin, Pérusse, & Gendreau, 1989) is the French version of 
Client Satisfaction Questionnaire-8 (CSQ-8, Larsen, Atkinson, Hargreaves, & Nguyen, 1979). This 
instrument is a self-reported eight-item measure to assess satisfaction with health care services. The 
response format is Likert type (1 to 4). A high total score indicates greater satisfaction. He demonstrated 
good internal consistency (α = .89) (Sabourin, et al., 1989). 
 
System Usability Scale (SUS; Brooke, 1996) is a usability questionnaire that has been adapted into 
French. It will be sent to participants in the Web-based intervention only after the eight weeks of the 
program in order to measure their level of satisfaction with the program. This questionnaire contains 10 
items (eg: I find that the features of this online workshop are well integrated) and responds on a five-point 
Likert scale (not at all strongly agree). A question will be added to ask participants about the number of 
modules they have completed. This questionnaire will take less than two minutes to complete. 
 
Follow up only (week 20 and 28): 
 
Patient 
Global 
Impression 
of 
Change 
(PGIC, 
5 
items).  
This tool assesses the level of change in pain, functioning, quality of life and psychological well-being 
factors over the past three months. They are evaluated on a 7-point Likert scale from 0 (significantly 
increased) to 6 (significantly decreased). A fifth item evaluates pain relief in the past three months and is 
measured on an ordinal scale ranging from 0 (no relief) to 100 (complete relief). This tool is increasingly 
used to assess the impact of change in the lives of patients with chronic pain (1 minute). 
 

 
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Data analysis: 
The sample size for this study is optimized to compare the expected results on post-treatment pain 
interference. In addition, we expect the effect size for the web-based group to be higher than for the 
bibliotherapy. Randomized trials using an ACT intervention for chronic, web-based pain reported effect 
sizes of d = 0.33 (Trompetter et al., 2014), d = 0.56 (Buhrman et al., 2013). ) and d = 0.58 (Lin et al., 
2017) with respect to pain-related interference. Considering the attrition of about 25% (between pretest 
and stimulus), based on the calculations of Lin et al. (2014), to obtain a statistical power of 80% (5%) and 
to detect an average effect size (d = 0.40), which proves clinically satisfactory for this type of study, a 
sample of 100 participants per group (300 in total) is required according to our calculations on G * power. 
 
Generalized linear models with a group-by-time interaction will be used to compare the time conditions 
of the ACT-guided group with bibliotherapy and education brochures. Dichotomous arrival points will be 
modelled using a binomial distribution and a log link while a normal distribution and identity link will be 
used in the case of continuous arrival points. The generalized estimating equations approach will take 
into account the correlation between measurement times. Contrasts, defined a priori based on research 
hypotheses, will be used to make comparisons between groups and different measurement times. The 
analyzes will be performed according to the intent to treat. 
 
Considering the current waiting lists for accessing psychological services in the public system, the social 
relevance of developing the accessibility of a self-help intervention by the Web is undeniable. We hope 
that our statistical data will support the development of new practices in the management of patients with 
chronic pain. The innovation will provide access to effective therapy in a short time and at low cost with 
a cost-benefit ratio. 
 
 
 
 
 
 
 
 
 
 
 

 
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