Chronic PainNCT05050565
Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study
An observational study of Chronic Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
Chronic pain in general is a substantial problem and is a source of a great deal of disability and suffering. It is known that processes like stigma and psychological flexibility (PF) play a significant role in these outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Experiences of stigma and psychological flexibility in chronic pain participants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 404 participants
- Where
- 1 siteSweden
- Study dates
- 8 Oct 2021to 4 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People suffering from a chronic pain condition, such as fibromyalgia, chronic back pain, endometriosis, vulvodynia, or other chronic pain conditions.
Who may be able to join
- Aged 18 or over
- Suffering from chronic or recurrent pain for ≥ 3 months
- Access to an internet enabled phone/computer/tablet
- Fluent in written Swedish
- Willing to be contacted during the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Uppsala University
Uppsala, Uppland, 75236
About this study
Chronic pain in general is a substantial problem and is a source of a great deal of disability and suffering. It is known that processes like stigma and psychological flexibility (PF) play a significant role in these outcomes. At the same time, there are many specific chronic pain disorders and there is less knowledge about similarities and differences between these specific conditions, whether the role of processes like these vary between conditions or not. For studies that can address this to be done in Sweden, there will need to be adequately translated and validated measures of the key processes identified.
The main aim of the current study is to look at whether the role of PF and stigma in pain-related outcomes differ across pain conditions. In support of that, a secondary aim is to first validate measures of stigma and PF in chronic pain populations. For this secondary aim, the current study seeks to investigate the factor structure, construct - and criterion validity, internal consistency, and test-retest reliability of a Swedish version of the Multidimensional Psychological Flexibility Inventory (MPFI) as well as of a Swedish version of the Stigma Scale for Chronic Illnesses (SSCI-8).
Read the detailed description
Chronic pain is related to impaired everyday functioning and social adjustment, such as working ability or engaging in recreational activities, and to emotional suffering, such as depression. Sexual functioning and satisfaction may be impaired for patients with vulvodynia and in some cases for patients with endometriosis. Pain seems to interfere with sexual functioning even for people with low back pain and fibromyalgia. Chronic pain is also related to anxiety, and the chronic pain literature often highlights the role of catastrophizing thoughts in exacerbating the experience of pain. Stigma and psychological flexibility (PF) appear to play a role in the suffering endured by people with chronic pain, but it is less clear how these processes differ, or not, between specific pain conditions such as, but not limited to, fibromyalgia, chronic low back pain, endometriosis and vulvodynia. Thus, the main aim of the current study is to investigate this by having participants with various chronic pain conditions fill out measures on stigma and psychological flexibility, and to see how these processes differ across conditions.
However, there is currently a lack of measures in Swedish to adequately capture stigma and psychological flexibility satisfactory. A secondary aim is thus to validate a Swedish version of the Multidimensional Psychological Flexibility Inventory (MPFI) and the Stigma Scale for Chronic Illnesses (SSCI-8).
In order to establish construct- and criterion validity, scores on these measures will be compared to that of related outcomes such as specific facets of psychological flexibility, pain interference, depression, social adjustment, and catastrophizing. In addition, test-retest reliability, internal consistency and factor structures for each measure, the SSCI-8 and the MPFI will be examined.
If eligible, participants will be directed to answer questionnaires via RedCap, a GDPR-compliant mobile application. After finishing the questionnaires, the participants will be reminded after two weeks in order to fill out the same questionnaires once more. At this second time point, questions regarding participant characteristics such as demography and pain background will be excluded.
- Conditions
- Chronic Pain
- Being tested
- Experiences of stigma and psychological flexibility in chronic pain participants
- Keywords
- chronic pain, psychological flexibility, stigma
- Medical subject headings
- Chronic Pain, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiences of stigma and psychological flexibility in chronic pain participantsBehavioural
Chronic pain participants will answer questionnaires at two points in time, two weeks apart. These questionnaires ask about stigma and psychological flexibility, as well as depression, catastrophizing, pain interference, and social adjustment. The data collected is only observational and does not include any intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma Scale for Chronic Illnesses (SSCI-8)
The SSCI-8 is an eight-item measure including items reflecting both enacted and internalized stigma. Minimum score is 8, and maximum score is 40. Higher scores indicate a greater degree of stigma. It is administered alongside the other outcomes in order to establish validity. It is also administered in order to examine similarities and dissimilarities between different chronic pain conditions in the stigma experience and in its relationship to the other outcome measures. The SSCI-8 will be administered a second time in order to examine temporal stability of the instrument.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Multidimensional Psychological Flexibility Inventory (MPFI)
The MPFI is a 60-item measure reflecting all facets of psychological flexibility. The measure is divided into two overarching dimensions, namely inflexibility and flexibility. Each dimension contains 30 items, and in each dimension the minimum score is an average of 1 across the 30 items, while the maximum score is an average of 6 across the 30 items. For the inflexibility part of the MPFI, a higher average score indicates higher inflexibility. For the flexibility part of the MPFI, a higher average score indicates higher flexibility. The MPFI is administered alongside the other outcomes in order to establish validity. It is also administered in order to examine similarities and dissimilarities between different chronic pain conditions in psychological flexibility and in its relationship to the other outcome measures. The MPFI will be administered a second time in order to examine temporal stability of the instrument.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Secondary outcomes (7)
Chronic Pain Acceptance Questionnaire (CPAQ-8)
An eight-item measure on pain acceptance. The minimum score is 0, and the maximum score is 48. Higher scores indicate higher pain acceptance.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Committed Action Questionnaire 8-item version (CAQ-8)
An eight-item measure on committed action. The minimum score is 0, and the maximum score is 48. Higher scores indicate higher levels of committed action.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Five Facet Mindfulness Questionnaire (FFMQ) - acting with awareness facet
An eight-item subscale on acting with awareness. The minimum score is 8, and the maximum score is 40. It is possible to divide the summary score into an average score. If so, the minimum average score is 1, and the maximum average score is 5. Higher scores indicate lower levels of acting with awareness.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Patient Health Questionnaire (PHQ-9)
A nine-item measure on symptoms of depression, with a minimum score of 0 and a maximum score of 27. Higher scores indicate higher levels of depression. The scale also includes as additional item regarding how the depressive symptoms have interfered with everyday functioning.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Coping Strategy Questionnaire (CSQ) - catastrophizing subscale
A six-item subscale on pain catastrophizing. The minimum score is 0 and maximum score is 36. Higher scores indicate higher levels of catastrophizing.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Work and Social Adjustment Scale (WSAS)
The WSAS is a five-item measure on social adjustment. The minimum score is 0 and maximum score is 40. Higher scores indicate lower work and social adjustment.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Brief Pain inventory - short form (BPI-SF)
For this study, two items on pain severity, one regarding average pain severity during the last week and one regarding pain severity at the current moment, and nine items on pain interference will be used. Two out of the nine pain interference items, exploring how pain interferes with sexual activities and enjoyment of sex, have been created and added by the research team. The two pain severity items are each scored from 0 to 10, with 0 indicating the least amount of pain and 10 indicating the highest amount of pain. The original seven pain interference items are each scored in the same way, but can also together generate an average score, with the minimum average score then being 0 and the maximum average score being 10. A higher score indicates a higher level of pain interference. The two pain interference items created by the research team are each scored from 0 to 10, with 0 indicating the least amount of interference and 10 indicating the highest amount of interference.
Measured: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start8 Oct 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Buhrman, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050565
- Sponsor's protocol ID
- 20210629
- Status last verified
- Jan 2022
- First submitted
- 31 Aug 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sundstrom FT, Lavefjord A, Buhrman M, McCracken LM. Assessing Psychological Flexibility and Inflexibility in Chronic Pain Using the Multidimensional Psychological Flexibility Inventory (MPFI). J Pain. 2023 May;24(5):770-781. doi: 10.1016/j.jpain.2022.11.010. Epub 2022 Nov 25.
PubMed 36442815
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study
- ClinicalTrials.gov ID
- NCT05050565
- Acronym / sponsor ID
- 20210629
- Conditions
- Chronic Pain
- Keywords
- chronic pain, psychological flexibility, stigma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain in general is a substantial problem and is a source of a great deal of disability and suffering. It is known that processes like stigma and psychological flexibility (PF) play a significant role in these outcomes. At the same time, there are many specific chronic pain disorders and there is less knowledge about similarities and differences between these specific conditions, whether the role of processes like these vary between conditions or not. For studies that can address this to be done in Sweden, there will need to be adequately translated and validated measures of the key processes identified.
The main aim of the current study is to look at whether the role of PF and stigma in pain-related outcomes differ across pain conditions. In support of that, a secondary aim is to first validate measures of stigma and PF in chronic pain populations. For this secondary aim, the current study seeks to investigate the factor structure, construct - and criterion validity, internal consistency, and test-retest reliability of a Swedish version of the Multidimensional Psychological Flexibility Inventory (MPFI) as well as of a Swedish version of the Stigma Scale for Chronic Illnesses (SSCI-8).
Detailed description
Chronic pain is related to impaired everyday functioning and social adjustment, such as working ability or engaging in recreational activities, and to emotional suffering, such as depression. Sexual functioning and satisfaction may be impaired for patients with vulvodynia and in some cases for patients with endometriosis. Pain seems to interfere with sexual functioning even for people with low back pain and fibromyalgia. Chronic pain is also related to anxiety, and the chronic pain literature often highlights the role of catastrophizing thoughts in exacerbating the experience of pain. Stigma and psychological flexibility (PF) appear to play a role in the suffering endured by people with chronic pain, but it is less clear how these processes differ, or not, between specific pain conditions such as, but not limited to, fibromyalgia, chronic low back pain, endometriosis and vulvodynia. Thus, the main aim of the current study is to investigate this by having participants with various chronic pain conditions fill out measures on stigma and psychological flexibility, and to see how these processes differ across conditions.
However, there is currently a lack of measures in Swedish to adequately capture stigma and psychological flexibility satisfactory. A secondary aim is thus to validate a Swedish version of the Multidimensional Psychological Flexibility Inventory (MPFI) and the Stigma Scale for Chronic Illnesses (SSCI-8).
In order to establish construct- and criterion validity, scores on these measures will be compared to that of related outcomes such as specific facets of psychological flexibility, pain interference, depression, social adjustment, and catastrophizing. In addition, test-retest reliability, internal consistency and factor structures for each measure, the SSCI-8 and the MPFI will be examined.
If eligible, participants will be directed to answer questionnaires via RedCap, a GDPR-compliant mobile application. After finishing the questionnaires, the participants will be reminded after two weeks in order to fill out the same questionnaires once more. At this second time point, questions regarding participant characteristics such as demography and pain background will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People suffering from a chronic pain condition, such as fibromyalgia, chronic back pain, endometriosis, vulvodynia, or other chronic pain conditions.
Key inclusion criteria (5 listed)
- Aged 18 or over
- Suffering from chronic or recurrent pain for ≥ 3 months
- Access to an internet enabled phone/computer/tablet
- Fluent in written Swedish
- Willing to be contacted during the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiences of stigma and psychological flexibility in chronic pain participantsChronic pain participants will answer questionnaires at two points in time, two weeks apart. These questionnaires ask about stigma and psychological flexibility, as well as depression, catastrophizing, pain interference, and social adjustment. The data collected is only observational and does not include any intervention. | Behavioural | – |
Primary outcome
Stigma Scale for Chronic Illnesses (SSCI-8)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
The SSCI-8 is an eight-item measure including items reflecting both enacted and internalized stigma. Minimum score is 8, and maximum score is 40. Higher scores indicate a greater degree of stigma. It is administered alongside the other outcomes in order to establish validity. It is also administered in order to examine similarities and dissimilarities between different chronic pain conditions in the stigma experience and in its relationship to the other outcome measures. The SSCI-8 will be administered a second time in order to examine temporal stability of the instrument.
Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
The MPFI is a 60-item measure reflecting all facets of psychological flexibility. The measure is divided into two overarching dimensions, namely inflexibility and flexibility. Each dimension contains 30 items, and in each dimension the minimum score is an average of 1 across the 30 items, while the maximum score is an average of 6 across the 30 items. For the inflexibility part of the MPFI, a higher average score indicates higher inflexibility. For the flexibility part of the MPFI, a higher average score indicates higher flexibility. The MPFI is administered alongside the other outcomes in order to establish validity. It is also administered in order to examine similarities and dissimilarities between different chronic pain conditions in psychological flexibility and in its relationship to the other outcome measures. The MPFI will be administered a second time in order to examine temporal stability of the instrument.
7 secondary outcomes
Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Committed Action Questionnaire 8-item version (CAQ-8)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Five Facet Mindfulness Questionnaire (FFMQ) - acting with awareness facet
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Patient Health Questionnaire (PHQ-9)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Coping Strategy Questionnaire (CSQ) - catastrophizing subscale
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Work and Social Adjustment Scale (WSAS)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Brief Pain inventory - short form (BPI-SF)
Time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 36442815Sundstrom FT, Lavefjord A, Buhrman M, McCracken LM. Assessing Psychological Flexibility and Inflexibility in Chronic Pain Using the Multidimensional Psychological Flexibility Inventory (MPFI). J Pain. 2023 May;24(5):770-781. doi: 10.1016/j.jpain.2022.11.010. Epub 2022 Nov 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Buhrman, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma Scale for Chronic Illnesses (SSCI-8) (time frame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.