Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413914
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-01-17
Brief Title:
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease Including Validation of AE-FS
Sponsor:
Diakonhjemmet Hospital
Organization:
Diakonhjemmet Hospital
Study Overview
Official Title:
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease Including Validation the Questionnaire of AE-FS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 baselinestart of treatment end of treatment two months after end of treatment and after six months
Detailed 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 dont 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 lifegeneral 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 andor PCS can predict andor 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 EULARs 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 studypreparedness throughout the project period We plan to include up to 200 patients who participate in the treatment plan either individually or treated in a coursegroup 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 inclusionstart 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 NettskjemaTSD alternatively on paper
The data that is collected on paper is stored de-identified and locked in the office of the project employeearchive 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 NettskjemaTSD 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 EUs 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
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 dont 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 lifegeneral 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 andor PCS can predict andor 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 EULARs 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 studypreparedness throughout the project period We plan to include up to 200 patients who participate in the treatment plan either individually or treated in a coursegroup 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 inclusionstart 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 NettskjemaTSD alternatively on paper
The data that is collected on paper is stored de-identified and locked in the office of the project employeearchive 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 NettskjemaTSD 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 EUs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 656858 | REGISTRY | REK | None |