Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study
Phase: NA
Conditions: Chronic Pain
Sponsor: St. Olavs Hospital

Acceptance and Commitment Therapy with 
Enhanced Mindfulness for Chronic Pain 
 
 
Trondheim, Norway June 15, 2018 

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1. Project title 
Acceptance and commitment therapy with and without enhanced mindfulness 
training for chronic pain: A randomized controlled efficacy and mediator study 
 
2. Introduction 
During the last three decades numerous population-based surveys have presented surprisingly 
high prevalence figures of chronic pain, according to a recent systematic review (1). Our united 
Norwegian pain research group has estimated figures in Norway between 24 (2) and 29% (3) of 
chronic pain and a pooled prevalence of 31% worldwide (1). Chronic pain is estimated to affect 
100 million adult Americans at any given time and carries direct and indirect costs of over 600 
billion dollars annually in U.S. alone (4). In Sweden the costs are estimated to be 32 billion EUR 
per year (5). Despite this, and the fact that The Global Burden of Disease studies show that 
chronic pain conditions are the most important current and future causes of morbidity and 
disability across the world (6), little has so far been done. Treatment measures that have been 
initiated, like opioid treatment and repeated blocks, have not alleviated this significant health 
and societal problem. On the contrary, widespread use of opioids against chronic non-malignant 
pain has caused a fatal opioid epidemic in the US (7). Pharmacological pain management is still 
indicated for chronic nociceptive and neuropathic pain, but in most cases of chronic pain, no 
cause can be identified. In a major clinical examination study of chronic pain in the general 
population, our research group has confirmed that in more than fifty percent of the 
cases, musculoskeletal pain conditions dominate and no cause for the pain condition can be 
identified (8).  
 As non-pharmacological alternatives, psychosocial treatments have been recommended for 
chronic pain management (9). One such treatment is Acceptance and Commitment Therapy 
(ACT). ACT is based on Relational Frame Theory (RFT), a comprehensive theory about 
language and cognition (10). Treatment intends to help patients identify values (“what is truly 
meaningful to them”) and to set goals and take action according to their values. In addition, 
patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so 
that they have less impact on functioning and action, but addition of daily mindfulness training 
at home is not included (10). ACT is considered  a “third generation” variant of cognitive 
behavior therapy and has research support in the treatment of several mental health problems 
(11). Among patients with chronic pain, several small clinical trials have shown that ACT is 
superior to controls in terms of increasing function and improving mental health, with small to 
medium effect sizes (12). However, further methodologically robust trials are required (13). The 
primary aim of this study is thus to examine in a large sample of patients from four 
multidisciplinary pain centers whether ACT for chronic pain is more effective than a patient 
education program, and whether adding daily mindfulness training will improve the outcome. 
 
The question is, however, not only if it is effective, but "why, for whom, and under what 
circumstances?". Mediators and moderators of change are important to sort out. Identifying 
specific variables that mediate the effects of a treatment on patient outcome could facilitate 
refinement of theoretical models and the development of more effective treatments. Minimal 
research has so far been conducted with the aim to identify treatment effect moderators such as 
patient characteristics (phenotypes) that help us to match patients to appropriate and effective 
treatments. This is supposed to be one of the most important directions for future research in 
chronic pain (14-16). Secondary aims are thus to identify for whom the treatment works, for 
whom it is not effective, and to identify key mechanisms of change so that more effective 
variants of the treatment can be developed.  
 

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Current theories of chronic pain emphasize an important role for attentional processes (17). 
Attention is often subdivided into three independent networks : 1) alerting- which is readiness in 
preparation for an impending stimulus, including tonic effects that result from spending time on 
a task (vigilance) and phasic effects that are due to brain changes induced by warning signals or 
targets, 2) orienting- which is the selection of specific information from multiple sensory stimuli, 
and 3) executive attention- which is monitoring and resolution of conflict between activity in 
different neural areas (18). Alerting involves the brain`s noradrenaline system, which originates 
in the brain stem and mainly in the locus coeruleus. Orienting involves frontal and parietal areas, 
including the frontal visual fields and inferior and superior parietal lobe. Executive attention 
involves the anterior cingulate cortex, anterior insula and basal ganglia (19, 20). Several recent 
studies have shown that patients with chronic pain have an attentional bias towards painful 
stimuli and other negative information (21-23). Moreover, recent meta-analyses have shown that 
patients with chronic pain have reduced executive function including working memory deficits 
(24, 25). Recently it has also been demonstrated that attentional functioning predicts chronic 
pain (26). 
 
Mindfulness is typically described as non-judgmental attention to experiences in the present 
moment (27). It includes two modes of action: First, it requires the regulation of attention in 
order to maintain focus on immediate experiences such as thoughts, emotions, body posture and 
sensations. Second, it requires the ability to approach one’s own experience with openness and 
acceptance. Practicing mindfulness meditation may enhance attentional control, alter self-
awareness and improve emotion regulation. A systematic review found that early phases of 
mindfulness training might be associated with improvements in executive attention and 
orienting, while later phases might be more associated with improved alerting (28).  
 
Three studies have used neuroimaging to evaluate changes in pain processing through 
mindfulness training. Beginners showed increased activity in anterior cingulate cortex and 
anterior insula which are areas involved in the cognitive regulation of nociceptive processing, 
increased activity in the orbitofrontal cortex which is involved in reframing the evaluation of 
stimuli and reduced activity in the primary somatosensory cortex (29). Experienced users of 
mindfulness training showed decreased activity in dorsolateral and ventrolateral prefrontal 
cortex and increased activity in primary pain processing areas such as the insula, somatosensory 
cortex and thalamus (30, 31).  These findings suggest that mindfulness training alters the brain 
differently over time and has significant influence on cognitive processing over time. Although it 
is documented that brain regions relevant for the regulation of attention and pain show functional 
and structural changes following mindfulness training, it is not known whether these changes are 
actually related to improvements in attentional functioning and clinical outcomes among patients 
with chronic pain. If it turns out to be so, one may have discovered a major mechanism of 
change in pain processing and symptom reduction. Thus, one main aim of the present study is to 
examine if mindfulness training improves attentional functioning and if this potential 
improvement enhances the amelioration of pain.  
In ACT, mindfulness is included in ways to increase acceptance and psychological flexibility, 
but does not necessarily involve systematic practice over time(10). We will therefore investigate 
the effects of adding prolonged mindfulness training to ACT delivered to patients with chronic 
pain. Since mindfulness training may affect the brain differently over time, it is important to 
measure attentional functioning after early phases of mindfulness training (after four weeks) and 
after training systematically over a longer period (six and twelve months).  
Although improvement of attentional functioning may be a central mechanism of change (group 
level), it may not be an important mechanism of change in all patients (individual level). Several 
mechanisms, biological, psychological and social, have been suggested to maintain chronic pain 

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(32). It is reasonable to assume that all these mechanisms are more or less important in different 
pain conditions, in patients with different psychological makeups and patients living under 
different social and occupational circumstances. Some have argued for applying personalized or 
individualized treatment (33). As stated by Jensen in a comprehensive review in Pain (9): “If a 
clinician limits himself or herself to only one of the existing theoretical models or psychosocial 
treatments, then a subset of that clinician`s patients will be unlikely to receive optimum care.” 
We assume that it is vital to examine and diagnose each patient thoroughly in a standardized way 
before the start of a treatment trial to make it possible to identify common characteristics of 
patients who do not benefit much from the treatments (predictors of poor outcome). It also 
makes it possible to identify characteristics of patients who may profit more from one treatment 
than the other treatments (differential treatment effects). This is a second aim of the present 
study, namely to identify clinical predictors and moderators of change and possibly to identify 
distinct phenotypes. 
The research project has several methodological strengths:  
1. This will be the largest controlled study on ACT for chronic pain so far. Most patients with 
chronic pain without known cause referred to all the four major multidisciplinary pain centers in 
all health regions of Norway will be asked to participate in the study.  
2. The patients will receive high quality evidence based assessments by clinical experts 
specifically trained in pain diagnosis and given treatment conducted by highly qualified 
therapists with adequate training. Improvement in the quality of clinical practice in all regions in 
a standardized way will be the result immediately from the start of the project. 
3. This multisenter study will have coordinated data and equal treatment implementation since 
the four multidisciplinary pain centers already coincide with diagnosis, assessment and 
treatment. In the fall of 2017 they had a two-day meeting where all four presented their ACT 
group program for closer co-operation. Thus, the multicenter study is therefore highly feasible. 
4. The four centers have a response rate on internet-based self-report on almost 100% pre-
admission and about 80% one year after treatment from four identical online quality records. 
This self-report system will be used in the study and has been published as feasible by our 
research group (34). 
5. It should be possible to identify patient characteristics (phenotypes) that can guide 
clinicians in the future in the selection of which of the patients are likely to profit from ACT, and 
which patients are likely to receive benefits from the addition of mindfulness training.                                     
6. It should also be possible to identify patients who benefit less from the treatments and who 
may need other alternatives. Patient characteristics can help us to identify key target components 
in the development of new treatments for these patients.  
7. The theoretical hypothesis aiming to identify a key mediator of change is based on modern 
cognitive neuroscience including thorough neurobiological studies of the human brain.  
8. Both for self-report measures and attentional functioning the study will use safe computerized 
test systems the patients can complete in their homes. This will make it possible to increase the 
number of assessments without the subjects needing to return to the outpatient clinic. This will 
increase the quality of assessments and reduce the cost  
9. Since the study includes self-report assessment methods that are easy to deliver and score, it is 
also easy to translate the knowledge and procedures to other treatment facilities in Norway and 
internationally after the project period. 
 
2.1 Need description 
Patients referred to tertiary multidisciplinary pain clinics are those who generally have very poor 
functioning and they have often tried many standard treatments without effect. Many have 
experienced unsatisfactory or adverse effects of medication. To establish the efficacy of a 
psychological therapy would be of major benefit for this group of patients living with refractory 

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chronic pain. This multi-professional study has the potential to strengthen the disciplines by 
increasing our knowledge about efficacy of an increasingly popular psychological treatment. If 
shown efficacious and feasible, this study should provide evidence for educating other therapists 
working with chronic pain patients in the method. Investigating key methods of change may give 
knowledge necessary for developing and improving the therapeutic method.  
3. Hypotheses, aims and objectives 
The primary aim of the study is to investigate the effectiveness of ACT (group 1) and whether 
adding a component of mindfulness training (group 2) will improve outcomes on pain (primary 
outcome), attentional functioning, physical functioning and mental health (secondary outcomes), 
compared to a control group (group 3). A secondary aim is to assess the degree to which 
improvement in attentional functioning can act as a mechanism of change (mediator) in pain. A 
third aim is to identify patient characteristics (phenotypes) that predict treatment effects 
(moderators of change), or, equally important, that predict failure to achieve benefit.  
 
More specifically it is hypothesized that: 
1. ACT is more effective in improving pain (primary outcome), mental health and physical 
function (secondary outcomes) at 52 weeks compared to the controls (paper 1). 
2. ACT with an additional component of mindfulness training will be significantly more 
effective in reducing pain and improving mental health and physical functioning at 52 weeks 
than ACT without mindfulness training (paper 1). 
3. Patients receiving ACT with mindfulness training will from treatment start to treatment 
termination show significant improvement in orienting and executive attention reflecting 
enhancement in top down processing compared to those receiving ACT without mindfulness 
training and compared to control (paper 2). 
4. Patients receiving mindfulness training and continuing to practice until 32 weeks of follow-up 
will show significant improvement in alerting, reflecting enhancement in bottom up processing 
at 52 weeks follow-up compared to those who have discontinued practicing (paper 2).  
5. Patient improvement in alerting and executive attention during treatment predicts a reduction 
in pain at eight and 16 weeks of follow up (paper 3). 
6. Patients who continue to practice mindfulness training until 32 weeks of follow-up will report 
less pain at 52 weeks follow up compared to those who do not (paper 3).  
7. Patients with initial higher levels of attentional functioning, will report a significantly higher 
reduction in pain and improvement in physical functioning and mental health (paper 4).  
8. Patients with neuropathic pain, psychiatric and sleep disorders will have a worse outcome 
independent of treatment received (17) (paper 4). 
9. The cost effectiveness of ACT for chronic pain is superior to patient education (paper 5). 
10. Effects of ACT are maintained at three years follow up (paper 6).  
 
4. Project methodology  
4.1 Project arrangements, method selection and analyses 
4.1. 1. Sample 
At least 486 patients will be included in the study (see power analyses below). Patients will be 
included if they are referred to one of the pain clinics with a primary diagnosis of chronic pain 
lasting for at least six months. About 200 patients will be recruited from Oslo, 200 from 
Trondheim, 100 from Bergen, and 100 from Tromsø. Exclusion criteria will be severe somatic 
disease or severe mental disorder (ongoing mania, psychosis, suicidal ideation or substance 
abuse/addiction). In addition will patients who cannot communicate in Norwegian or who need 
24-hour personal assistance be excluded. Each treatment center will randomize the patients into 
three different research programs (see below).  
 

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4.1.2. Study design  
This is a three group randomized controlled trial with 162 patient in each group, six different 
measurement points, of which pre-treatment and 52 weeks after start of the treatment are the 
crucial points.  
 
4.1.3 Background for the interventions 
The choice of treatment conditions is based on the following reasons: 1. Mindfulness training 
has shown to be effective in both stress and pain reduction (35-37). 2. Mindfulness training has 
shown to alter brain functioning (differently in the short and long run). 3. Mindfulness training 
uses relevant techniques for improving attentional functioning, both focused attention (top down 
processing) and open monitoring of present moment experiencing (bottom up processing). 4. 
ACT has been shown to be effective in improving mental health and physical function in 
patients with chronic pain, but less so in reducing pain (12, 13). 5. ACT uses mindfulness 
techniques that do not involve meditation or training, but this may be included in the treatment. 
The research design thus makes use of a component analysis which is under- utilized in pain 
treatment research (9, 38). It makes it possible to identify if patients who receive both 
components (mindfulness training and ACT) obtain more gains than patients who receive only 
one component. 6. The education program does not involve the same components of change 
(attentional functioning, learning to live according to ones values and acceptance) as 
mindfulness and ACT.  
 
4.1.4 The intervention groups 
ACT (group 1) will follow a manual based on the work of Steven Hayes and colleagues (10). 
The manual is adapted to a group therapy setting and includes all the dynamic processes of ACT; 
committed action, values, self as context, presence in the moment, defusion and acceptance It 
has previously been piloted and applied to a work rehabilitation setting by our research group 
(39). Two qualified therapists will lead every treatment session.  
ACT with enhanced mindfulness training (group 2): ACT will be performed exactly as group 1, 
but in addition mindfulness exercises will be introduced in the ACT sessions and patients will 
receive audio recordings to aid practice daily at home. The home meditation exercises session 
will take from 10 to 30 min. and will be based on the program developed by Kabat-Zinn (27).  
The education program (group 3) aimed at improving self-management and social identification, 
will constitute the control group (40). Participants will receive information on relevant topics 
including pain and symptom management, stress, sleep, eating habits, mental health problems, 
communication skills and physical activity by a qualified health professional. They will have the 
opportunity to discuss their thoughts and experiences with the other patients in the group with 
the aim of strengthening social identity and support, which in turn is expected to foster more 
healthy management (41). This is regarded as a relevant control group because self-management 
programs may be cost-effective alternatives to other treatments, with likely effects on 
psychological well-being, but not on pain and disability (42).   
 
4.1.5 Organization of the groups  
The two active treatment programs and the education program all consist of eight four-hour 
group sessions (eight subjects) during an eight-week period. All therapists will before they are 
considered qualified receive clinical training within the specific treatment modality during a 
three month period including two 2-day workshops led by a certified trainer in each field. Each 
treatment session will be videotaped. A random selection of videotaped sessions will be scored 
by two experts to establish treatment variance, treatment adherence and treatment competence. 
Inter-rater reliability will be assessed. 
 

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4.1.6 Data collection 
Diagnostic status and assessment before inclusion: The four multidisciplinary pain centers have 
participated in 16 national meetings over the past four years were a common protocol for 
examining and assessing patients with chronic pain was developed. This is described in a recent 
study (8) which includes standard examination of neuropathic pain (30) and fibromyalgia (43). 
Patients will also be examined by a clinical psychologist for concurrent comorbid psychiatric 
disorder according to Structured Clinical Interview for DSM-5 (44).  
Primary outcome measure: Pain intensity measured by the Brief Pain Inventory including four 0-
10 numerical rating scales; pain now, least pain, worst pain, average pain (45). 
Primary process measures: Attentional functioning will be measured using the attention network 
test which is specifically designed to measure orienting, alerting and executive attention which 
can be reported the patients computer and lasts about 15 min (46).  
Secondary outcomes: Physical function and mental health measured by the SF-36 health survey 
(47), pain catastrophizing (48), fatigue (49), insomnia severity (50), subjective everyday 
memory problems (51), anxiety and depression (52), pain related beliefs and attitudes about 
sleep (53) and the five factor mindfulness questionnaire (54).  
Measure points: Primary outcome, attentional functioning and secondary outcomes will be 
assessed before treatment, end of treatment at eight weeks, 16 weeks, 32 weeks, and 52 weeks 
follow up from the patients ´computers after automatic cell-phone call. This is a privacy data 
security trusted reporting system shown by our research group to be feasible (34). Adherence to 
mindfulness will be assessed weekly by mobile SMS. 
Tertiary outcome measures: Changes in work participation will be analyzed from time of 
recruitment through one year. The first variable will be dichotomous and defined as participation 
in competitive work > day (7.5 hours) per week on average over 8 weeks. Days of paid work 
will be used as total number of days worked (continuous variable) in the follow-up period as a 
cumulative measure of work productivity. The data will be collected from the register of the 
Norwegian Labour and Welfare Administration (NAV). 
Cost-effectiveness and cost-utility will be assessed from a health service perspective and a 
societal perspective. The health service perspective will include intervention costs (assessment 
and treatment) and additional relevant primary and secondary health care costs. A micro-costing 
approach will be applied for calculation of intervention costs. Data on health service utilization 
will be collected from national and local registers in addition to a patient reported questionnaire 
to assure complete and relevant information.  The societal perspective will in addition include 
sick leave/productivity costs based on data from the register of the Norwegian Labour and 
Welfare. Cost-effectiveness will be assessed by comparing incremental costs to incremental 
primary and secondary outcomes. For cost-utility, Quality Adjusted Life Years (QALY) will 
serve as the outcome measure. QALY will be calculated from SF-6D (55) and taking time 
intervals into account.  
Other measures: Age, sex, civil status, education level, work and disability status, smoking, 
physical activity, diet and lifestyle habits, major life events and frequency (and time) practicing 
mindfulness.   
 
4.1.5 Statistical power  
We calculated sample size based on an assumption of a mean baseline pain intensity of 5.4 with 
a standard deviation of 2.1 (56) and a 10% reduction in pain intensity in the education group, 
20% in the ACT group and 30% in the ACT with mindfulness training group. These 
improvements may be regarded as minimally important vs moderate changes, respectively (16, 
57). For a two-sided test with 5 % significance level and 80% power, we calculated that the 
number of patients needed to compare ACT with mindfulness to the education group was 58 in 
each group. Comparing ACT with and ACT without mindfulness training would require 141 in 
each group, and comparing ACT without mindfulness training to education would require 126 in 

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each group. We increased group size to 162 participants per group to allow for dropout, to 
provide equality between groups and for secondary analyses. Both intention to treat and 
treatment completer analyses will be conducted. A detailed data analysis strategy will be 
outlined before collecting the data. 
 
4.2. Participants, organization, collaboration and dissemination 
The research project will be conducted by a research consortium which will have meetings 
quarterly, as well as a scientific collaborative group. The role, position and competence of the 17 
active partners who have developed this application are listed and described in detail in the 
application form. One is a user participant (see paragraph 5 below), one is an international 
partner from Uppsala, Sweden, four are from Helse Midt, three from from Helse Sør-Øst, three 
from Helse Nord and two from Helse Vest, three have their primary positions at the universities 
(Trondheim and Oslo), and one is a researcher and a health economist. They will all continue to 
have an active role in the described project, thirteen as researchers, and thirteen as clinicians, and 
one as user.  
 
The 13 clinicians who are among the most experienced pain clinicians in Norway are leading 
psychologists, physicians, and physiotherapists from each of the centers. Five have led ACT and 
mindfulness training and have published scientific articles on the subjects (58, 59). The head of 
the multidisciplinary pain centers in the four Norwegian university hospitals, who already meet 
several times a year within the Norwegian Pain Center Network (homepage smertenettverk.no) 
will, together with the user participant, constitute the research consortium. At the beginning of 
the study project, there will be several meetings, one concerning the treatment protocol led by 
Stiles and Jacobsen (ACT therapy and mindfulness training), one on ICD-10-diagnoses 
including neuropathic pain and fibromyalgia (Borchgrevink, Stubhaug, Woodhouse), and one 
about psychiatric and neuropsychological aspects and diagnoses (Stiles, Landmark, Landrø).   
 
4.3. Budget 
The budget is shared between the four centers and details are given in the electronic application.  
 
4.4. Plan for activities, visibility, and dissemination 
A time period of five years is scheduled for completing the entire project. Details are given in 
the electronic application. Results will be communicated to researchers, clinicians, patients, user 
organizations, and the public and politicians/decision makers. The results will be published in 
international journals with a high impact factor. The research project will be the basis for four 
PhD-theses. The results will be disseminated to other clinicians and clinics through clinical 
workshops and lectures, through popular papers in relevant medical, physiotherapeutic and 
psychological journals, communication on the e-network for Norwegian General Practitioners 
(Eyr), and through the Norwegian Competence Centre for Complex Symptom Disorders using 
information leaflets, supervision and conferences. The results will be communicated to user 
organizations in close collaboration with them. The results will also be communicated to the 
general population and politicians through articles in newspapers and specific magazines or 
websites. This may also include meetings with politicians and policy makers or informing the 
Norwegian health authorities through meetings or informational letters. 
 
Planned scientific papers are: 
1. Comparing ACT with and without enhanced mindfulness training to a patient education 
program: a randomized controlled trial (hypothesis 1 and 2). 
2. Does mindfulness training improve attentional processes in chronic pain patients? Secondary 
analyses from a randomized controlled trial (hypothesis 3 and 4). 

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3.  Are effects of ACT and mindfulness training for chronic pain mediated by changes in 
attentional processing? Results from a randomized controlled trial (hypothesis 5 and 6). 
4. ACT for chronic pain, for whom does it work? Moderators of change in a randomized 
controlled trial (hypothesis 7 and 8). 
5. Patient education or ACT for chronic pain? A cost-effectiveness analyses of a randomized 
controlled trial (hypothesis 9). 
6. The long-term effects of ACT for chronic pain, a three-year follow up from a randomized 
controlled study (hypothesis 10). 
 
4.5. Plan for implementation 
The research consortium ensures that the research study is closely affiliated with the routine 
clinical practice in all four health regions. Specific researchers and specific clinicians are 
geographically located in each region to ensure that the recruitment, assessment and treatment of 
patients are conducted in accordance with the research protocol and can ensure that the study can 
be implemented immediately. Already in 2023 it should be possible to begin the implementation 
of new empirical knowledge from this research project into the routine practice of the clinics 
participating in the study and to offer other pain clinics and rehabilitation centers nationally and 
internationally, including psychiatric outpatients clinics, concrete ways of implementing this 
knowledge into their assessment and treatment programs. A great advantage of this research 
project is that it makes use of practical and specific tools and procedures which are theoretically 
and empirically founded in cognitive neuroscience and within modern clinical psychology and 
medicine which makes translation into new clinical procedures convenient.  
5.  User involvement 
The User Committee at St. Olav´s hospital has appointed Anne Lein as the user participant to 
follow the research field for Department of pain and complex symptom disorders. She accepted 
in 2017 to be engaged in the planning process and be part of the Research Consortium that will 
meet four times a year (see paragraph 4.2 above). She proposed that one of the groups should be 
mindfulness training, which was accepted. She got the first draft at the same time as the other 
partners and thereafter she was part of a planning meeting. Besides inclusion of an active user 
participant in the Research Consortium monitoring the study, “The Norwegian society for 
chronic pain patients” has been informed with an  overview of the project in Norwegian, and 
their leader Turid Leganger has responded positively. During the project period four additional 
user representatives, one in each region, will be selected by User organizations. They will be 
involved in all stages of planning and implementation as well as during results analyses and 
results communication. These four representatives will have formal meetings with the Research 
Consortium and members of the Scientific network group at treatment start and each spring and 
each autumn during the entire project period. 
6. Ethical considerations 
The research project will be submitted to a Regional Committee for Ethics in Medical Research 
and will be conducted in accordance with the declaration of Helsinki and the Principles of Good 
Clinical Practice. Participation in the study will be based on informed consent including 
willingness to be videotaped. Thorough information will be provided both orally and in writing 
to potential participants. None of the treatments are considered to be harmful. If negative side 
effects occur, they will be reported in detail in the patient-specific study file and in the hospital 
record. They will also be reported in scientific publications. If a serious adverse event or a 
serious side effect occurs, the patient will be advised to resign from the study and will be given 
adequate attention and treatment. Negative side effects/serious adverse events will also be 
reported to relevant health authorities  Data used for research purposes will be stored without 
personal identifying information for five years after the end of the study. Participants will be 

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informed of data storage procedures. The study will be registered at clinicaltrials.gov and 
helsenorge.no.  
 
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