Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Mixed Anxiety Depression, Diabetes Mellitus Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease and Post COVID-19 Fatigue)
Phase: NA
Conditions: Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease, COVID-19
Sponsor: Helse i Hardanger

 
 
7. February 2022 
Protocol for a non-randomized clinical intervention study- 
Concentrated Cross-disciplinary Group Intervention for Common 
Health Complaints (Including Post COVID-19 Fatigue)   
 
 
Authors: Gerd Kvale1,2, Bente Frisk3,4, Marte Jürgensen1,3, Tore Børtveit1,3, Øystein Theodor 
Ødegaard-Olsen3,5, Ane Wilhelmsen-Langeland1,3, Bernt Bøgvald Aarli3,6,8, Kristina 
Sandnes3, Sidsel Rykken3, Anne Haugstvedt3,4,Eirik Søfteland3,7,8 
 
1Division of Psychiatry, Haukeland University Hospital, Bergen, Norway 
2Department of Clinical Psychology, University of Bergen, Norway 
3Helse i Hardanger, Øystese, Norway 
4Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, 
Bergen, Norway 
5 Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, 
Bergen, Norway 
6 Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway  
7 Department of Medicine, Haukeland University Hospital, Bergen, Norway 
8 Department of Clinical Science, University of Bergen, Norway 
 
 
 
 
Approved REK Vest (Regional Ethical committee): 2020/101648 

 
 
7. February 2022 
 
Introduction 
 
An ageing population with a growing burden of chronic, complex diseases seriously 
challenges our ability to deliver adequate health services [1–3]. Adding to this, the ongoing COVID-
19 pandemic has resulted in a new group of patients, who, having recovered from the acute infection 
may suffer from a range of long-lasting symptoms. This hitherto unknown condition is frequently 
termed post-COVID 19 syndrome (or long COVID) and may also affect people in which the primary 
infection was mild [4,5]. If we do not succeed in delivering treatment that enables the patients to deal 
effectively with their long-lasting illnesses, the public health care system is unlikely to cope with the 
upcoming demographic challenges [6,7].  
Although patients with chronic illnesses suffer from a wide range of symptoms, pain and 
fatigue are among the most common [8,9]. Medical advice typically encourages the patient to be as 
active as possible, to eat healthily, get enough sleep and avoid stress [10–12], and to monitor 
improvement or worsening by using medical diaries and symptom logs [13]. Since the patient’s main 
concern is to prevent worsening of the condition, activities that might increase symptoms are typically 
avoided [14]. Examples of such behavior patterns can be to restrict physical activity upon muscle pain, 
to stand, walk or move carefully, to rest or sleep whenever feeling exhausted or tired, and rest before 
or after engaging in activities. Over time, such coping strategies are likely detrimental and might 
contribute to a conservation or worsening of the symptoms. This is especially the case when the first 
indication of improvement might be a temporary worsening of symptoms, such as muscle pain or 
tiredness after increased physical activity. 
Based on extensive experience with concentrated treatment formats [15–19], we have 
developed a comprehensive trans-diagnostic rehabilitation for chronic illnesses, characterized by a 
systematic focus on how to initiate and maintain change. In the presently described protocol, this 
intervention will be piloted on patients suffering from a diversity of chronic health challenges; chronic 
low back pain, post-COVID-19 symptoms, anxiety and depression, and diabetes type 2. These 
conditions were chosen as they collectively represent major personal and societal costs [20]. 
Furthermore, their inherent disparities allow us to maximize the knowledge gained in this pilot study. 

 
 
7. February 2022 
Finally, by including patients with post-COVID-19 symptoms (fatigue, dyspnea, problems with 
concentration, diurnal pattern and/or nutrition), we may be able to further advance this field, as there 
presently are large knowledge gaps concerning the long-term prognosis and natural development of 
the complaints [21].  
One of the main features of this novel, cross-disciplinary concentrated intervention (lasting 
less than a week) is a shift in focus from targeting symptoms to targeting and monitoring everyday 
micro-choices that facilitate increased levels of functioning. The intention of these micro-choices is to 
break inflexible patterns of symptom regulation by “doing something different” whenever tempted to 
be guided by the symptoms. This approach enables the patient to systematically increase flexibility 
and their level of functioning when the symptoms and health challenges are present. In addition, a 
focus on deliberate behavior instead of symptoms, implies that change is within reach and possible to 
control. 
In order to ensure a safe setting in which participants may challenge their current coping 
strategies, they will work together with an interdisciplinary team and each patient will design 
individually tailored plans for the most relevant micro-choices. To ensure that the patients are prepared 
to initiate change, they are thoroughly introduced to the program prior to treatment, and if reluctant, 
they are encouraged to postpone participation until ready. After the concentrated intervention, the 
patients will be prepared to integrate the changes as part of their everyday living.  
The aim of this pilot study is to explore the acceptability of the concentrated interdisciplinary 
group rehabilitation for patients with chronic low back pain, post-COVID-19 symptoms, anxiety and 
depression, and diabetes type 2, and describe basic changes in functional status. Based on our 
experiences with other concentrated treatment formats, we expect the intervention to be highly 
acceptable and to have significant effects on functional impairment [15–19]. 
Main hypotheses 
 
• 
The treatment will be acceptable for the patients, regardless of illness, and they will complete 
the treatment  
• 
Patients will be satisfied with the treatment 

 
 
7. February 2022 
• 
There will be a significant reduction in how much the illness affects the patients’ life  
• 
The patients’ level of functioning will be improved at follow-up. 
Methods 
This pilot study is part of the “Project Development of Smart Health Solutions” (PUSH project), a 
collaboration between Haukeland University Hospital (Bergen, Norway) and Helse i Hardanger 
(Øystese, Norway). The overall aim of the PUSH project is to develop more efficient and cost-
effective treatments to be integrated as part of the public health care. The project is headed by a 
steering committee at Haukeland University Hospital, whereas the interventions and study data 
collection are primarily done at Helse i Hardanger, a health care research facility located outside 
Bergen. 
Study design and participants 
This study is designed to test the acceptability of the concentrated interdisciplinary group 
rehabilitation in an open pre-post follow-up design, for four groups of patients with chronic illnesses: 
chronic low-back pain, post-COVID-19 symptoms, chronic obstructive pulmonary disease, anxiety 
and depression, and diabetes type 2. The treatment will be delivered in groups of 6-10 patients, and the 
initial pilot study will include between 40 and 50 patients for each illness (4-6 treatment groups for 
each illness). For inclusion and exclusion criteria, please refer to Table 1, and for an overall study 
flowchart, Figure 1.  
Procedures and patient flow 
Although patients themselves may initiate the process, all potential participants need to be referred by 
their general practitioner or other physician responsible for the treatment of the relevant condition. If 
the patient fulfils the inclusion criteria, they will be invited to sign the informed consent, and offered 
participation in the project successively upon availability in the groups.  
One of the clinicians will call the patients upon referral and check the inclusion/exclusion 
criteria. During this phone call, the patients will be informed about the PUSH project and that the 
intervention is a concentrated, interdisciplinary group treatment that will take place in Øystese, outside 
Bergen. If they fulfil the inclusion criteria and none of the exclusion criteria, an appointment for 
screening will be made. Before they answer the online questionnaires, they will be asked to watch 

 
 
7. February 2022 
videos describing the program, to ensure that all participants receive the same information (at the 
homepage www.helseihardanger.no) [22]. For low-back pain and diabetes type 2 the informed consent 
will be signed online, while patients with post-COVID-19 symptoms or anxiety/depression will sign at 
baseline testing, when the first face-to-face meeting takes place. For low-back pain and diabetes type 
2, participants will be invited in groups to an approximately two-hour meeting 1-3 weeks before the 
treatment to make sure that they are prepared for the intervention. For patients suffering from anxiety 
and depression, or post-COVID-19 symptoms, the same information will be provided individually 
during the screening. All patients will be contacted by a therapist during the week prior to the 
treatment to confirm that they have received all necessary information and are ready to start their 
concentrated rehabilitation.  
Outcomes 
Assessments will be performed before and one week after the concentrated rehabilitation program, and 
after 3, 6 and 12 months. An overview of the measurement tools and the respective assessment times 
are presented in Table 2. The outcomes are selected with the aim of describing the overall experiences 
with the concept of the concentrated treatment format. More detailed, disease-specific outcome 
measures are also assessed, but will not be presented in this generic protocol paper, as they pertain to 
other aspects than the concentrated treatment format per se. The initial results will be published 
following 3 months of follow-up, whereas final results are to be published upon 12 months of follow-
up. 
Primary outcome measures 
Acceptability: The acceptability of the treatment will be measured by the following variables: 1) The 
proportion of patients accepting to participate in the treatment of those fulfilling inclusion criteria and 
offered participation, 2) The proportion of patients offered participation that start treatment, and 3) 
The proportion completing the treatment program (on-site). 
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item questionnaire that measures patient 
satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very 
high satisfaction) [23]. The total score ranges from 8-32, with higher scores indicating higher degree 

 
 
7. February 2022 
of satisfaction. The CSQ-8 has good psychometric properties, with high internal consistency 
(Cronbach’s α = .93), and high inter-item correlation [24].  
The Brief Illness Perception Questionnaire (Brief IPQ) is a 9-item questionnaire designed to assess 
cognitive and emotional representations of illness [25]. Questions are graded from 1 to 10. The last 
item deals with perceived cause of illness, in which respondents list the perceived three most 
important causal factors in their illness. For this questionnaire, the general word ‘illness’ can be 
replaced by the name of a particular illness. The word ‘treatment’ in the treatment control item can be 
replaced by a particular treatment such as ‘surgery’ or ‘physiotherapy’. The scale has good 
psychometric properties according to a recent review [26]. 
The Work and Social Adjustment Scale (WSAS) is a short questionnaire measuring the impact of the 
illness on aspects of work and social activities [27]. The scale consists of five items rated from 0 (not 
at all) to 8 (very severe), and higher score indicates higher impairment (maximum score is 40). The 
scale is regarded as reliable and valid, with good psychometric properties. 
 
Trans-diagnostic secondary outcome measures: At pre- and post-treatment and the follow-up 
assessments the patients will be asked to rate on a scale from 0-100 to what extent they use the 
following strategies when trying to handle the symptoms: 
a) Wait to start an activity until I feel up to it  
b) Wait to start an activity until I am certain that I will succeed  
c) Ensure that the symptoms will not get worse 
d) Ensure that I am prepared to handle challenges 
e) When I get anxious I try to calm down before I proceed 
 f) Spend a lot of time on worrying and ruminating 
g) Avoid socializing if I do not feel up to it  
h) Ensure that I get enough rest  
i) Try to not let others see how I feel 
 j) Try to have a positive mindset  
k) Follow my gut feeling 

 
 
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The intervention 
The intervention consists of three equally important phases (see Figure 1): 1) Preparing for change, 2) 
The concentrated intervention, 3) Integrating change into everyday living. Throughout the 
intervention, the focus is on how to initiate and maintain change by utilizing discomfort as a guide to 
break inflexible patterns of symptom regulation. By intention, the topics introduced in the different 
phases overlap considerably. In order to incorporate the central aspects of a given health challenge, 
minor illness-specific adaptations are made to the intervention.  
 
Phase 1: Preparing for change  
It is essential that the patients are thoroughly informed and prepared prior to the rehabilitation, and 
that they have made an active choice to initiate change. During the pretreatment information meeting, 
the following topics will be covered using non-technical terms and easily understandable metaphors 
(with slight illness-relevant modifications):  
a. Improved everyday functioning. The goal of this program is to help the participant to live a life 
where the symptoms/ health challenges do not decide how the person behaves. Thus, it is a 
program focused on change, with the goal of a better life and improved everyday functioning. 
b. Challenge patterns of symptom regulation. Living with a chronic illness implies that patients are 
continuously trying to prevent their health from getting worse, which makes sense. However, one 
of the consequences might be that the patients develop patterns of symptom regulation that might 
contribute to a conservation – or even in some instances exacerbate - the problem. Typically, the 
patient finds it hard to know when to be cautious and when to challenge a given strategy to deal 
with the symptoms. In our experience, people with chronic illnesses typically have an adequate 
understanding of their problems, but this does not necessarily lead to change. Rather it may 
increase the feeling of helplessness because they do not know how to initiate and sustain change. 
The concentrated treatment is a practical, deliberate approach focused on how to identify and 
break unhelpful patterns of symptom regulation. 
c. Therapist-assisted behavior activation. In line with the above, the illness is frequently a composite 
of health challenges that might require expertise from a number of specialized professions. During 

 
 
7. February 2022 
four consecutive days (three for post-COVID-19 symptoms), a highly qualified interdisciplinary 
team will provide practical information and hands-on coaching while the patients challenge the 
way symptoms are handled. Patients referred to the program for anxiety and depression are prior 
to treatment expected to provide suggestions regarding unhelpful patterns of regulation which they 
are willing to start changing during the concentrated treatment days, e.g. avoidance of specific 
situations, social withdrawal etc.  
d. Group setting. The concentrated treatment is delivered in groups of 6-10 patients. The participants 
will work side by side and challenge their own expectations regarding what they are capable of 
doing. In the group setting, each participant will need to take responsibility for making the 
treatment sessions relevant for their specific problems. 
e. Basic bodily rhythms. An important aspect of the treatment is a focus on the practical implications 
of bodily rhythms such as sleep-wakefulness, activity-rest, and meal habits.  
f. Substantial self-effort. All participants are expected to stay at the adjacent hotel throughout the 
treatment week, to dedicate full days to the treatment and engage in all parts of the program from 
8:30 am to 4:00 pm. The last day, the program will be finished after lunch. From 4:00 to 7:00 pm, 
each participant will practice on their own based on what they learned during the treatment. This 
means that there will not be room for other appointments during the concentrated intervention 
period and their full focus will be on changing their unhelpful behavior patterns.  
g. Start planning life after the concentrated intervention. Since the focus is to increase the level of 
functioning, it is necessary that each participant, prior to the intervention, decides upon how to 
practice the changes and integrate them into their lives, starting directly after the intervention. This 
includes specific plans to increase participation at work/school or other activities that will lead to 
better daily functioning. 
h. Not participate until you are ready. No treatment or medicine works if the patient is not willing to 
take it – this even goes for penicillin. If the patients are reluctant to participate, we recommend 
them to wait until they are ready to make a change.  
 

 
 
7. February 2022 
An adapted version of the Borkovec and Nau (1972) Reaction to treatment scale is used to explore the 
patients’ readiness for treatment [28]. A low rating (<70%) on any of the four questions “How much 
does this approach make sense?”; “How likely is it that you would recommended this treatment to a 
friend with similar problems?”; How likely is it that you will be fully engaged in the program?”; “How 
likely do you think it is that you will benefit from the program?” will serve as an opportunity to clear 
up any misunderstandings, and together with the patient, decide if it might be better to postpone 
treatment initiation.  
 
Phase 2: The concentrated group intervention  
The program starts with patient education, and the most important points will be repeated throughout 
the week. At the first session, rules of confidentiality will be established. During the first part of day 
one, each participant will provide some information about his/her health problem based on the 
following: “How long have you struggled with this health challenge?”, “What does it prevent you 
from doing?”, “What are you looking forward to do when this is no longer a problem?”. The 
participants will use 2-3 minutes each. Patient education will be interspaced with physical activity, 
brief mindfulness sessions, and practical training sessions focused on breaking problematic patterns of 
symptom regulation 
 
Trans-diagnostic elements of the group intervention: 
a. Patient education on how to initiate and maintain relevant change and at the same time accept those 
things that cannot be changed or controlled [e.g. history, thoughts and feelings (for post-COVID-19 
symptoms and diabetes type 2: getting the infection / having the illness)]. It will be underscored that 
change starts with an active decision, and that the goal of the treatment is to increase flexibility and to 
live a life where the symptoms do not decide.  
b. Micro-choices will be used as a term which refers to the moments when you discover specifically 
how and where in your everyday life the symptoms are making choices on behalf of you, and where 
you have an option to choose differently. Participants will be encouraged to do things they have 
avoided in fear of symptoms worsening. It will be emphasized that change is measured in behavior; 

 
 
7. February 2022 
what you do, and not in reduction of symptoms. Symptom reduction on the other hand, will be 
described as a positive and valuable side effect of behavioral change. This shift in focus, from 
symptoms to deliberate behavior implies that change is within reach. Furthermore, participants will be 
challenged to do a value-based micro-choice each day, e.g. call a friend or relative whom they had 
neglected due to the health problems. During patient education, this concept is introduced and 
explained (i.e. having health problems and symptoms may make people more self-centered and to lose 
perspective, making them lose track of who they were. Value-based actions may help them get back 
on track and widen their focus). 
c. Individually tailored practice in discovering micro-choices and “breaking problematic patterns” in 
as many relevant settings as possible will be the cornerstone of each day.  
d. Feedback and coaching. Each morning, at lunchtime, and at the end of the joint program, everyone 
will be asked to share their self-evaluation on how successful they have been in identifying their own 
patterns of symptom regulation, and to what extent they have attempted to break the patterns. A scale 
from 1-6 will be used. If they rate themselves lower than a 6, the group leader will explore the reasons 
for this, with the aim of helping them to find the moments of “micro-choices” and to identify what 
they can do to break the pattern. Throughout these sessions, symptoms will not be given attention, but 
rather described as being important in order to be able to identify targets where it might be possible to 
break the patterns of regulation.  
e. Physical activity. These sessions will vary across illnesses, however, common for all participants 
will be instructions to attempt making the physical activity relevant for their own challenges and fit 
into their projects of “breaking patterns of symptom-regulation”. For some, this might mean to refrain 
from the temptation to overdo, for others, it might imply to be more active, – or active in a different 
way. For patients with anxiety/ depression the task during the physical activity will be to “surprise 
themselves” by doing a little more when they feel they have reached their limit. Patients with low-
back pain will follow the validated ready-to-use program “GLA:D® Back”, integrating patient 
education and exercise therapy [29,30]. For post-COVID 19 patients, the physical training will be a 
mix of high- and low-intensity training, focusing on increased exercise capacity and the restoration of 

 
 
7. February 2022 
trust in one’s own body. In the diabetes type 2-group, the main aim will be to experience how a 
diverse range of activities can be useful in order to maximize the effect of the body’s available insulin.  
f. Mindfulness. Each day will contain 1-3 brief sessions of detached mindfulness where the task will be 
to focus on the breathing, while at the same time observe (and accept, without trying to change), 
wandering thoughts, bodily sensations etc [31].  
g. Food and meal habits. One of the patient education sessions will be focused on useful dietary 
choices. For patients with post-COVID-19 symptoms affecting diet and/or nutrition, the focus will be 
on useful dietary choices with a focus on helping the body to recover. In patients with anxiety and 
depression, the focus is on the establishment of good mealtime habits as a way of restoring diurnal 
rhythms. For patients with diabetes type 2, the emphasis will be to explore how to get the maximum 
out of the available insulin (i.e. their beta-cell capacity or their insulin injections). During this session, 
they will also test different “forbidden” (carbohydrate-rich) food items and evaluate the consequences 
on their blood glucose levels. This will be followed by physical activity, to experience the restoration 
of habitual glucose levels. The aim is to recognize that no food is forbidden, but that there are 
consequences of the choices, with various possible compensatory actions. 
h. Pharmacist. For all participants, a pharmacist reviews the individual medication lists, focusing on 
potential harmful interactions. In the low-back pain group, two sessions of patient education are 
provided. First on various types of formulations and medications in general, followed by an illness-
specific session focusing on risks of combining pain medication, potential impact on driving 
capabilities and an overall emphasis on minimizing the use of opioid-based and other pain-relief 
symptom treatment. Individual advice on the downsizing and discontinuation of medication is 
provided in cooperation with the study physician. Following the same pattern, the diabetes type 2 
group also have two interactive educative sessions with the pharmacist. Here, the second session deals 
specifically with diabetes medications; – use, effects, and most common side-effects. For patients with 
Post-COVID-19 symptoms, a short patient education is followed by a brief counseling session with a 
pharmacist on proper use of inhalators.  

 
 
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i. Afternoon practice. Before the group split at 4:00 pm each day, individual practice plans for each 
afternoon and evening will be made, focusing on implementing micro-choices in terms of physical 
activity, social/value-based activity, self-reflection etc.  
j. Individual consultation. During the program, all patients will receive an individual consultation with 
the group leader or one of the psychologists or psychiatrists who are experts on the concentrated 
treatment format. This consultation will be focused on how to integrate the change into everyday 
living.  
k. Preparing for life after the treatment. By the end of the program, all patients will have made a 
specified plan addressing how to integrate the change into normal living using the concept of SMART 
goals (Specific, Measurable, Achievable, Relevant, Time-bound) [32,33]. Also, they will start 
answering the following daily questions on-line: “To what extent did you allow the symptoms to 
decide today” (0-10) and “To what extent did you make use of the principle of ‘doing something 
else’” (0-10). 
 
Phase 3: Integrating the change into everyday living 
Daily online reports. For three weeks after the concentrated program, through a digital solution, all 
patients will answer the two daily questions (described above) pertaining to the maintenance of the 
change. This will be done without feedback from the program. Helse i Hardanger is in the process of 
developing a smart-phone application through which the patients are expected to answer 
questionnaires, store their SMART-goals and provide feedback. The program will facilitate contact 
with the clinic if needed.  
Individual video or phone consultation. Ten days after the concentrated treatment, an individual phone 
or video consultation is performed, focusing on how to maintain the change. Additionally, patients 
with low back pain follow the program for GLA:D® Back, with bi-weekly training for eight weeks at 
certified local GLA:D® Back facilities. 
Further follow-up and data gathering. All patients will answer questionnaires at 3-, 6- and 12-months 
follow-up. Further disease-specific examinations and/or data may also be gathered, however, the 
description of these are outside the scope of this generic protocol paper.  

 
 
7. February 2022 
Competency in the concentrated treatment format 
A psychologist with extensive experience with concentrated treatment formats will lead all groups for 
patients with anxiety/depression, and these groups will be used for hands-on training in the format for 
clinicians working with the other illnesses. The content of all manuals (Standard Operating 
Procedures) is supervised and approved by the originator of the format (GK), and all groups will 
receive hands-on supervision daily from GK.  
Statistical analysis plan (SAP) and data handling 
Data will be analyzed with Stata version 16.1 (StataCorp LLC 2019, College Station, TX, USA). For 
the initial pilot study, linear mixed models will be used to evaluate changes in the trans-diagnostic 
primary outcome measures from pre-treatment to post treatment and 3-months follow-up. Between 
illness differences in measured change will be explored by including interactions between time (pre-
treatment, post-treatment, and 3-month follow up) and illness. Statistically significant interactions will 
be followed by examination of simple effects. Within-group effect sizes will be calculated on complete 
data using Glass´ Δ, with pretreatment SD as denominator. Glass’s Δ is the recommended effect size 
for intervention studies in which there are reasons to believe that the treatment will influence the 
standard deviation as well as the mean [34]. An effect size is commonly interpreted as small (0.2), 
moderate (0.5), and large (0.8) 
Following the principle of intention-to-treat, all participants will be included in the analyses, 
irrespective of missing data at any of the assessment points. Mixed models do not assume balanced 
data and are able to account for missing data on the outcome variable by using all available data on 
each participant. Under the missing at random (MAR) assumption, these models provide unbiased 
estimates [35].  
Clinically significant change will be assessed using the criteria of Jacobson and Truax (1991). 
These specify that 1) The patients’ pre-post (pre-follow-up) change score on the primary outcome 
measures is larger than the measurement error (Reliable Change Index) and 2) The post-treatment 
(follow-up) score is outside of the patient sample’s pre-treatment distribution (defined as M - 2SD) or 
within the normal group’s distribution (defined as M + 2SD). 

 
 
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Data collection and monitoring:  
For each illness, a centralized team will be established. This team will have monthly contact with one 
designated researcher for each illness in order to monitor inclusion and data collection. Most of the 
data will be collected electronically and all sensitive data stored on an encrypted server at Helse Vest 
IKT. Once the patients are included, all data entered by participants are monitored by the Study 
Administrative Team.  
 
Adverse events 
If an acute condition should occur, patients will receive the necessary care, and patients might be 
excluded from the study if there are concerns about safety. Such patients will be thoroughly described 
and accounted for, in line with the illness-specific Standard Operating Procedures.  
 
User involvement  
The project has established a broad user panel with representatives recruited through HUS and HiH. 
The following organizations are represented: Norwegian Asthma and Allergy Association, Norwegian 
Rheumatics’ Association, Mental Health Norway, Breast Cancer Association, Norwegian Diabetes 
Association, Norwegian Association for Lung and Heart Disease, “Grannehjelpa” («Neighbors’ 
help»). The panel has given feedback throughout the development of the protocol and approved the 
final version.  
Ethical considerations 
The PUSH project as well as the web application is approved by the Research ethical board, Helse 
Vest 2020/101638 and will be conducted in accordance with the Helsinki Principles.  
Gender perspectives 
The inclusion as well as all interventions are gender neutral. However, in order to ensure adequate 
external validity and proper representation we have no absolute limits in terms of minimum inclusion 
rates of one gender. For all illnesses, the project will aim for at least 30-70 representation of the 
genders.  
Discussion 
In this paper, we describe a protocol for the establishment and initial evaluation of a novel, 
concentrated interdisciplinary group rehabilitation for patients with chronic low back pain, post-

 
 
7. February 2022 
COVID-19 symptoms, COPD,  anxiety/depression or diabetes type 2. To our knowledge, this will be 
the first study to evaluate concentrated interdisciplinary group rehabilitation for such a diverse range 
of chronic health issues. Based on previous experiences with the short, concentrated treatment format, 
we hypothesize that the intervention described will be positively received by the participants, will 
reduce the impact of the illness on their lives, and will improve the level of daily functioning.  
 
The study is designed with participants as their own controls (pre-post comparisons) with a 12-month 
follow-up. Although this allows for summarizing the experiences and findings as described above, 
causal conclusions on the effects of the intervention may not be drawn. However, in our mind, this is 
an essential first step enabling subsequent separate controlled trials where such research questions – as 
well as the cost-effectiveness issues – may be addressed. Still, the modest labor factor (ten patients, 
two group leaders) compared to traditional rehabilitation projects clearly benefit our concentrated 
treatment format, if shown to be efficacious.  
 
If the intervention is followed by meaningful improvements for the participants, we will be able to 
help large groups of patients with chronic illnesses to adhere to choices in their daily living that 
eventually will enhance their functional status. Due to the concentrated format, the fact that 
participants need only 3 or 4 days of sick leave to take part in the intervention, with the continued 
rehabilitation process at home is another clear advantage. Existing rehabilitation programs for chronic 
illnesses often have a duration of 3-4 weeks or longer, and therefore requires longer time away from 
home and for those who are working, longer sick leave. Another benefit of our intervention is the 
focus on implementing micro-choices in everyday life, with guided practice during the intervention 
and the assisted introduction into the life at home and work. Although this needs to be investigated, 
the aim is to ensure the long-term maintenance of the new life trajectory. 
 
Considering the methodology, dropouts and poor adherence to the intervention can threaten the 
internal validity. Although proper information aims to limit this problem, we cannot be sure that the 
participants will participate for the whole period or whether they will complete digital and clinical 

 
 
7. February 2022 
examinations at 3- 6- and 12-month follow-ups. A notice will be sent to the patients about two to three 
weeks before the assessments will take place. Participants who are not answering the questionnaires 
online, or meet to the clinical examinations, will be contacted by telephone. Impact of missing data 
will be assessed with appropriate statistical methods, e.g., linear mixed models, multiple imputations, 
and sensitivity analysis. 
 
This protocol describes a novel trans-diagnostic rehabilitation approach, and the illnesses in focus are 
clearly disparate. Hence, if the intervention in the described study appears effective, this could also 
trigger new studies investigating the effects on other chronic diseases or health challenges. In line with 
this, and to facilitate potential dissemination of the concentrated rehabilitation format, a training 
program for relevant health professionals will be made available. 
Conclusion 
We present a protocol for the establishment and evaluation of a novel, concentrated treatment to be 
investigated on patients with chronic low back pain, COPD, post-COVID-19 symptoms, 
anxiety/depression and diabetes type 2. The treatment focuses on how to initiate and maintain change, 
with a shift away from monitoring symptoms towards an active approach to daily health-promoting 
micro-choices. This short intervention has the potential of fundamentally changing the way we deliver 
health care to these patient populations, and hence could be a useful addition to the treatment 
armamentarium of the health care system, in the face of the coming socio-demographic challenges. 

 
 
7. February 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1: Flowchart of the study 
1 Illness-specific physical exercise test and examinations. Evaluation with questionnaires at pre-treatment one 
week and 3-, 6- and 12-months follow-up.  
2 1) To what extent did you allow the symptoms to decide to-day (0-10) and 2) To what extent did you make use 
of the principle of ‘doing something else’ (0-10). 
Assessed for eligibility 
Preparing for change: 
Active choice to initiate change 
 
  
Concentrated group intervention 
- 3 days: post-COVID symptoms 
- 4 days: diabetes type 2, chronic low 
back pain and anxiety/depression 
Integrating change into everyday 
life for all groups 
- Chronic low back pain: group training 
program for 8 weeks 
Postponement of 
treatment for 
patients who are not 
ready for change. 
  
Enrolment 
  
Exclusion of patients 
not meeting the 
inclusion criteria. 
Baseline measurements: 
- Questionnaires 
- Physical examinations1 
Daily online follow-up for 
three weeks  
- Two questions2  
  
PHASE 3 
  
  
PHASE 2 
  
  
PHASE 1 
  
Follow-up for 3, 6 and 12 
months 
- Questionnaires1 
- Physical examinations1  

 
 
7. February 2022 
Table 1. Inclusion and exclusion criteria 
Inclusion criteria 
Exclusion criteria 
For all diagnoses 
• Fluent in oral and written Norwegian 
• Access to smartphone and sufficient digital 
competence to handle online questionnaires  
• Negative COVID-19 PCR test 
 
• 
Cognitive failure 
• 
Lack of self-reliance in daily routine 
• 
Severe mental health problems preventing 
engagement in the rehabilitation program 
• 
Conditions that inhibit physical activity 
Chronic low back pain 
• Low back pain with or without radiculopathy  
• Age between 18–70 years old 
• Low back pain >3 months, and at least 4 months of 
sick leave  
• Able to participate at a group based post-treatment 
physical training in Bergen, Voss or Kvam 
municipalities 
• 
Surgery during the last 8 weeks 
• 
Available alternative rehabilitation therapy for 
low back pain 
Diabetes type 2 
• Type 2 diabetes  
• Age >18 years 
• Have at least one of the following complications/ 
challenges: 
- 
Dysglycemia 
- 
Frequent or severe hypoglycemia  
- 
Weight gain  
- 
Diabetes complications  
- 
Diet, physical activity and/or medical treatment 
challenges 
• 
Type 1 diabetes 
• 
Monogenic diabetes 
• 
Secondary diabetes (pancreatogenic or any 
other forms of secondary diabetes). 
• 
Ongoing pregnancy  
 
Post-COVID-19 Symptoms 
• 
Age between 18–67 years 
• 
>2 months since the COVID-19 infection 
• 
Impaired ability to work full-time  
• 
Substantial post-COVID-19 related physical and/or 
mental health problems  
• 
Fatigue 
• 
Dyspnea 
• 
Concentration difficulties 
• 
Sleeplessness, diurnal disturbances 
• 
Nutritional deficiencies  
• 
Exercise contraindicated 
 
Anxiety or depression 
• 
Age between 18- 47 years  
• 
Fulfilling ICD-11 criteria for one of the following 
disorders:  
- 
Mixed anxiety and depressive illness  
- 
Other mixed anxiety illnesses  
- 
Unspecified anxiety illness  
- 
Generalized anxiety illness  
- 
Depressive episode  
- 
Recurrent depression  
- 
Unspecified recurrent depression  
• 
Bipolar illness 
• 
Psychosis 
• 
Ongoing substance abuse/dependence 
• 
Ongoing suicidal ideation 
 
 

 
 
7. February 2022 
Abbreviations: PCR: polymerase chain reaction; ICD: International Classification of Illnesses 

 
 
7. February 2022 
 
Table 2. Questionnaires, clinical and physical examinations 
Questionnaires and assessments     
Assessment point 
• Client Satisfaction Questionnaire 
• One week post rehabilitation 
• Brief Illness Perception Questionnaire 
• Baseline, one week, 3-, 6- and 12-months post 
rehabilitation 
• Work and Social Adjustment Scale 
• Baseline, 3-, 6- and 12-months post rehabilitation 
• Strategies for handling symptoms, rating 0-100 
and two questions1 
• Daily reports for 21 days post rehabilitation 
• Baseline, one week, 3-, 6- and 12-months post 
rehabilitation 
• Patient Activation Measure 
 
 
• Consumption of health care 
 
• Medication lists 
 
• Body weight/body mass index 
 
• Baseline, one week, 3-, 6- and 12-months post 
rehabilitation 
• Baseline, 3-, 6- and 12-months post rehabilitation  
 
• Baseline, 3-, 6- and 12-months post rehabilitation  
 
• Baseline, 3-, 6- and 12-months post rehabilitation  
 
• Baseline, 3-, 6- and 12-months post rehabilitation 
1 To what extent did you allow the symptoms to decide today” (0-10) and “To what extent did you make use of the principle 
of ‘doing something else’” (0-10). 
 

 
 
7. February 2022 
 
 
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