NCT05050565

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

August 31, 2021

Last Update Submit

January 10, 2022

Conditions

Keywords

chronic painpsychological flexibilitystigma

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Chronic PainSocial Stigma

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • Monica Buhrman, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

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

Locations