Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study
1 other identifier
observational
404
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2022
CompletedJanuary 11, 2022
January 1, 2022
3 months
August 31, 2021
January 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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 immediately following participant consent to undertake survey, and again two weeks thereafter
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Interventions
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.
Eligibility Criteria
People suffering from a chronic pain condition, such as fibromyalgia, chronic back pain, endometriosis, vulvodynia, or other chronic pain conditions.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychology, Uppsala University
Uppsala, Uppland, 75236, Sweden
Related Publications (1)
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.
PMID: 36442815DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Buhrman, PhD
Uppsala University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 20, 2021
Study Start
October 8, 2021
Primary Completion
January 4, 2022
Study Completion
January 4, 2022
Last Updated
January 11, 2022
Record last verified: 2022-01