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Clinical Trials/NCT05050565
NCT05050565
Completed
Not Applicable

Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study

Uppsala University1 site in 1 country404 target enrollmentOctober 8, 2021
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Uppsala University
Enrollment
404
Locations
1
Primary Endpoint
Stigma Scale for Chronic Illnesses (SSCI-8)
Status
Completed
Last Updated
4 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
October 8, 2021
End Date
January 4, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Chronic Pain Acceptance Questionnaire (CPAQ-8)(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Committed Action Questionnaire 8-item version (CAQ-8)(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Five Facet Mindfulness Questionnaire (FFMQ) - acting with awareness facet(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Patient Health Questionnaire (PHQ-9)(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Coping Strategy Questionnaire (CSQ) - catastrophizing subscale(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Work and Social Adjustment Scale (WSAS)(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)
  • Brief Pain inventory - short form (BPI-SF)(Measured immediately following participant consent to undertake survey, and again two weeks thereafter)

Study Sites (1)

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