Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06413914 |
| Other study ID # |
DS-00805 |
| Secondary ID |
656858 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 16, 2024 |
| Est. completion date |
December 31, 2030 |
Study information
| Verified date |
May 2024 |
| Source |
Diakonhjemmet Hospital |
| Contact |
Kåre Osnes, PhD |
| Phone |
+47 92833866 |
| Email |
kare.osnes[@]diakonsyk.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Catastrophic thinking is a risk factor for a poor prognosis for pain in general and rheumatic
disease in particular, which for many contributes to a behavioral pattern characterized by
avoidance. Other people with long-term pain, on the other hand, have a pattern where they
suppress thoughts and feelings of fear associated with pain, and push themselves to carry out
activities. An inappropriate form of endurance can help maintain and intensify pain. The
AE-FS is a short version of the Avoidance-Endurance Questionnaire with different subscales
for maintaining activity despite pain. AE-FS can be of great clinical utility. The study of
patients with rheumatic disease and long-term pain will validate a Norwegian version of the
AE-FS as well as examine how the AE-FS seen in connection with other relevant questionnaires,
including the Pain Catastrophizing Scale , reflects mechanisms for change in cognitive
behavioral therapy for long-term pain. The effect of the intervention is evaluated with
questionnaires at baseline/start of treatment, end of treatment, two months after end of
treatment and after six months.
Description:
Background for the project Up to 30% of the adult population in Norway state that they have
had long-term pain . Long-term pain in the musculoskeletal system accounts for 50% of
disability cases and is the most frequent cause of long-term absence. This group includes
rheumatic disease, back and neck disorders, pelvic pain and shoulder problems. Rheumatic
disease is a collective term for over 200 different diseases that are divided into
inflammatory rheumatic disease (arthritis, spondyloarthritis, psoriatic arthritis, connective
tissue diseases and vasculitis), degenerative diseases (arthrosis) and soft tissue rheumatism
(fibromyalgia). Fibromyalgia is characterized by widespread and long-lasting muscle pain and
occurs in about 5% of the population.
The pain picture in rheumatic disease is complex with different pain mechanisms and frequent
comorbidity with sleep difficulties, fatigue and psychological problems. The pain can be
linked to inflammation and to structural changes, but also to changes in the central nervous
system.
With support from Stiftelsen Dam, the Unit for mental health services in somatics and the
Unit for research and innovation at the Adult Psychiatric Department Vinderen and the Clinic
for Rheumatology, Outpatient Clinic and Research, Diakonhjemmet Hospital, have developed an
intervention based on clinical health psychology and cognitive behavioral therapy. The target
group is primarily patients with long-term pain and rheumatic disease. The treatment is
described in a chapter in the Handbook of Clinical Health Psychology .
A workbook for pain has been developed, following revisions and feedback from 15 individual
patients and participants in 2 treatment groups (one physical and one digital) who have
followed the scheme. The workbook contains knowledge about pain and pain management,
describes measures and homework from session to session. The treatment offered in the project
spans 8 sessions of 2 hours each and is carried out either digitally or by physical
attendance. A corresponding manual has also been developed for individual treatment over
approx. 10 sessions of 45 minutes. The patients are called in for a follow-up appointment 2
months after the ordinary termination.
Negative thought and reaction and behavior patterns in long-term pain Catastrophic thinking
is an inappropriate coping style where one overestimates the threat of pain, ponders the
causes and is worried about the consequences. In arthritis, catastrophic thinking predicts
more intense pain and severe depression symptoms and poorer physical function . In knee
osteoarthritis, catastrophizing predicts a longer postoperative course in hospital, and more
avoidance of physical activity .
Some patients suppress thoughts associated with pain or the fear of it and push themselves to
carry out activities. It represents an inappropriate and inflexible form of endurance, which
can contribute to maintaining and intensifying pain.
The short version AE-FS can be of great clinical value. A patient with high scores on the
questionnaire may be in a vicious circle which in the long term increases pain and affects
quality of life. The patient ignores the pain or the fear of it, and does not pay necessary
attention to it. The form consists of 9 statements, 7 of them on two scales for mild and
severe pain, respectively, where you must indicate whether and how often you have acted in
this way in the last two weeks. Examples of statements are:
"When I am in pain
- I try not to take any notice of it.
- I clench my teeth.
- keep appointments even though I don't feel up to it.
There are 7 answer options (never, almost never, seldom, sometimes, often, mostly and
always). In addition, the patients are asked to indicate their mood and the possibility of
depressive symptoms in the last two weeks, more specifically if they enjoy things just as
ever and think they make decisions about as well as ever.
Issues for the study
1. The AE-FS questionnaire can be of great clinical value for mapping behavior and thoughts
in mild and severe pain, both to predict long-term pain and as an educational tool in
the treatment of patients. In the project, we will validate the form, by assessing its
suitability for our patient group and compliance with other validated forms which, among
other things, measure pain, depressive symptoms, anxiety symptoms and function.
2. In the project, we also want to evaluate the feasibility and effect of the treatment
for:
1. Pain, measured by the Brief Pain Inventory questionnaire - short form (Cleeland &
Ryan, 1994)
2. General symptoms, measured by the PROMIS-29 questionnaire (Patient reported
outcomes measurement information system).
3. Quality of life/general health, measured by the EQ-5D-5L questionnaire (general
health questionnaire).
4. Any other relevant questionnaires.
5. Feasibility and satisfaction, including attendance, dropouts, etc.
3. We also want to investigate whether negative thought and reaction and behavior patterns
in long-term pain measured by AE-FS and/or PCS can predict and/or mediate treatment
response when it comes to pain.
4. We also want to evaluate other possible predictors of treatment response, such as age,
sex, duration of pain, etc.
Method and implementation In the study, we will evaluate the effect of the intervention using
questionnaires at baseline, at the start of treatment, at the end of treatment, at the
booster time two months after the end of treatment and 6 months later.
Suitable forms have been assessed in consultation with the reference group. We use the
following forms:
Brief Pain Inventory - short form ; PROMIS-29 (Patient reported outcomes measurement
information system); generic EQ-5D-5L (general health and quality of life questionnaire), PCS
(Pain Catastrophizing Scale), AE-FS (The avoidance-endurance questionnaire - short form, ),
and four questions from the MCQ (MetaCognition Questionnaire) about positive assumptions
about worry and an assumption that worry cannot be controlled, respectively. Patients must
also fill in a background form upon inclusion with, among other things, demographic
variables, and possibly simple "anchor questions" aimed directly at current issues.
We will also register attendance and non-attendance, possibly from the patient record.
Treatment within the project Cognitive behavioral therapy is the psychological approach that
has the best evidence for long-term pain in general, and which is highlighted as a
theoretical framework in EULAR's recommendations for patient education in rheumatic disease.
Cognitive behavioral therapy is associated with better outcomes of rehabilitation for
long-term pain in general, reduced pain intensity and less use of medication and health
services.
There is evidence that exposure therapy aimed at pain-related avoidance behavior reduces the
symptoms of fibromyalgia . Work with pain-related imagery as well as motivation, goals and
values and measures to strengthen compliance when using rules of action are also included. In
addition, measures are taken to influence patterns of action characterized by inappropriate
endurance and accompanying overload.
Participants in the study/preparedness throughout the project period We plan to include up to
200 patients who participate in the treatment plan, either individually or treated in a
course/group at the Unit for mental health services in somatics, Diakonhjemmet hospital. The
patients included have both a rheumatic disorder and a long-term pain condition.
All patients have an assessment interview with a psychologist associated with the project,
before starting the treatment. There they will receive information about the treatment and
the research project. They are told that participation in the project is voluntary and that
it is perfectly fine to receive the treatment without participating in the research. If they
then express that they are interested in participating in the research project, they will
receive written and verbal information about the project (consent form), and information
that, prior to the start of treatment, they will receive a link via SMS, where they can sign
the consent and fill in the questionnaires. Alternatively, in the assessment interview, they
will be given a written consent form and the questionnaires which they can hand in to the
researchers in the study, possibly sending in a pre-stamped envelope.
The included questionnaires are completed at inclusion/start of treatment, end of treatment,
at the follow-up appointment 2 months after the end of ordinary treatment and 6 months later.
In order to ensure privacy and good quality of the answers, the research participants are
informed that the forms should be completed in quiet surroundings without public exposure. In
the consent form, they will also receive information that the forms will only be used in the
research and that they can contact the project manager throughout the project period if
filling in the forms would result in negative reactions or the need for clarifying
conversations. If necessary, they can have a conversation with the psychologist responsible
for the treatment.
Project group The project group for the study is divided into two parts, where the
psychologists Elin Fjerstad, Torkil Berge and Ingrid Hyldmo are responsible for the
development and implementation of the treatment and the researchers Kåre Osnes (project
manager), Selle Aarrestad Provan, Rikke Helene Moe, Bente Bull-Hansen and Andrew Malcolm
Garratt are responsible for the research part of the project. Everyone in the research group
is employed at Diakonhjemmet hospital.
Handling of data Patients fill in the questionnaires digitally via Nettskjema/TSD,
alternatively on paper.
The data that is collected on paper is stored de-identified and locked in the office of the
project employee/archive. The data is transferred de-identified and stored on an
access-controlled research server. The code list is stored in a separate access-controlled
folder on the research server, where only the project manager and employees responsible for
research logistics have access. The data will be anonymised (the code list will be deleted
and other personally identifiable information will be removed) no later than five years after
the end of the project (the end of the project is tentatively 31 December 2030).
The data that is collected digitally via Nettskjema/TSD is transferred to an
access-controlled folder in the research server.
According to the new General Data Protection Regulation (GDPR), the controller at
Diakonhjemmet hospital and project manager Kåre Osnes has an independent responsibility to
ensure that the processing of personal data has legal basis. This project has legal basis in
the EU's GDPR article 6 no. 1a and article 9 no. 2a, consent. The project will be assessed by
the data protection representative and the research committee at Diakonhjemmet hospital.
The results will be published in scientific journals, through the user organisations'
magazines and websites, and spread through social media.
The project is a collaborative project between the Department of Adult Psychiatry and the
Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY).
REMEDY is an interdisciplinary research center led by Diakonhjemmet hospital in partnership
with Oslo University Hospital. The research center aims to improve the treatment of
musculoskeletal diseases and has a particular focus on intervention studies in people with
auto-immune rheumatic diseases. The center is funded by the Research Council, which is a
research center for clinical treatment, and by the Olav Thon Foundation
Schedule
Course and processing with collection of personal data: 2024-2027 Analyzes of research data:
2027-2028 Publication with writing of articles 2028-2030
