Clinical trial NCT05050565: Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study
Official title: Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: chronic pain
psychological flexibility
stigma
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People suffering from a chronic pain condition, such as fibromyalgia, chronic back pain, endometriosis, vulvodynia, or other chronic pain conditions.

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.

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

Primary outcomes:
measure: Stigma Scale for Chronic Illnesses (SSCI-8)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Secondary outcomes:
measure: Chronic Pain Acceptance Questionnaire (CPAQ-8)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Committed Action Questionnaire 8-item version (CAQ-8)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Five Facet Mindfulness Questionnaire (FFMQ) - acting with awareness facet
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Coping Strategy Questionnaire (CSQ) - catastrophizing subscale
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
measure: Brief Pain inventory - short form (BPI-SF)
timeFrame: Measured immediately following participant consent to undertake survey, and again two weeks thereafter
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Psychology, Uppsala University
state: Uppland
Study officials:
affiliation: Uppsala University
name: Monica Buhrman, PhD
role: PRINCIPAL_INVESTIGATOR
References: