EndometriosisNCT05518630
An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
An observational study of Endometriosis and Vulvodynia, run by Uppsala University at 1 site in Sweden.
Trial summary
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. Despite the significant prevalence of all three conditions, they are receiving relatively little attention in psychological treatment research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometriosis, Vulvodynia, Fibromyalgia
- What is being tested?
- Nomothetic Versus Idiographic Assessment in Chronic Pain
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2022to Aug 2023
- 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 reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia.
Who may be able to join
- Age 18 or over
- Reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia
- The pain condition present persistently or recurrently during ≥ 3 months
- Access to an internet-enabled smartphone/tablet
- Fluent in written Swedish
Who cannot join
- Planned surgery during the upcoming 6 weeks
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Psychology, Uppsala University
Uppsala, Uppland, 75236
Monica Buhrman, PhD, 0046184712126, monica.buhrman@psyk.uu.se
About this study
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. Despite the significant prevalence of all three conditions, they are receiving relatively little attention in psychological treatment research. Despite the popularity of methods that rely on aggregated group data, such as randomized controlled trials (RCTs), concerns have been raised in recent years about the generalizability of results from these methods to the individual level - group-to-individual generalizability. Since psychological treatments in the clinic are focused on enhancing the well-being of a specific individual this might affect how researchers should study these conditions. The current project aims to investigate: (a) item suitability for daily assessment of psychological variables, (b) group-to-individual generalizability in outcome measures frequently used in psychological studies and treatments of chronic pain, (c) relations over time between process and outcome variables, and (d) possible differences in results obtained across three pain conditions.
Read the detailed description
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. The pain conditions are associated with suffering both psychologically and physically. However, knowledge about these conditions is scarce.
The present study aims to investigate the relationship between pain intensity, psychological flexibility, pain functioning, catastrophizing, and depressive symptoms in people with endometriosis, vulvodynia, and fibromyalgia. The investigators want to investigate how these factors relate to each other over time, but also whether there is a difference between people who are in contact with health care for these conditions and those who are not, and whether there is a difference depending on which of the included pain conditions one has.
Another aim of the project is to investigate whether the variables the investigators intend to measure meet the criteria for group-to-individual generalizability, meaning that group means and correlation coefficients based on aggregated group data also apply to individuals and that it is reasonable to draw conclusions about individuals from group data. Many psychological variables do not meet the criteria for this type of generalizability. By examining whether the results from variables can be generalized from a group level to an individual level, the investigators will gain clues about how much individualization is required in future research, assessments, and treatments for the pain conditions included in the current project.
In order to investigate group-to-individual generalizability, the project requires a large sample of participants to obtain group averages but also a large number of repeated measurements over a longer period of time for each participant. Repeated measurements from each individual are planned to be carried out to obtain individual mean values, in order to compare this with the group data. A diary will be created which is intended to be used daily, and a further aim of this study is to evaluate whether this diary is valid to use for future studies in these pain conditions.
On the first day of the study, participants will complete forms collecting demographic and background information, including information about the participants' pain.
On the first as well as the last day, information will also be collected from standardized questionnaires, including the Multidimensional Psychological Flexibility Inventory (MPFI), Patient Health Questionnaire-9 (PHQ-9), Brief Pain Inventory (BPI), and Pain Catastrophizing Scale (PCS).
On the second day of the study, participants will start to fill in twice daily measures at fixed times, and with a 12-hour interval between these two daily measurements. These are based on an ecological momentary assessment approach (EMA), where frequently repeated measurements are taken in the natural environment of the research subjects and where the time that participants have to think back on when answering is kept short. Using EMA, the within-individual variation can be easily monitored over time. The daily measurements will be collected for 42 days. The measurements consist of items from MPFI, BPI, PHQ-2, and PCS. In addition, two items are developed by the research team to assess sexual functioning and energy levels.
Participants will also fill out a weekly diary administered six times in total. The weekly diary consists of three items asking the participant to rate the previous week, and indicate whether something out of the ordinary has happened.
- Conditions
- Endometriosis, Vulvodynia, Fibromyalgia
- Being tested
- Nomothetic Versus Idiographic Assessment in Chronic Pain
- Keywords
- Endometriosis, Vulvodynia, Fibromyalgia, Psychological flexibility
- Medical subject headings
- Endometriosis, Vulvodynia, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nomothetic Versus Idiographic Assessment in Chronic PainBehavioural
Participants with either endometriosis, vulvodynia, and/or fibromyalgia will answer a twice-daily diary for 42 days and a short weekly diary six times in total. In addition, they will answer two longer surveys at the start and at the end of the 42 days. These questionnaires ask about psychological flexibility, depression, catastrophizing, and pain interference. 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.
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility subscale
A 30-item measure reflecting all facets of psychological inflexibility, namely: experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The minimum score is an average of 1 across the 30 items, and the maximum score is 6 across the 30 items. It can also be scored on a facet level with a minimum score of 1 and a maximum score of 6 for the individual facet scored. A higher average score indicates higher psychological inflexibility.
Measured: Measured immediately following participant consent to undertake survey
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility subscale
A 30-item measure reflecting all facets of psychological inflexibility, namely: experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The minimum score is an average of 1 across the 30 items, and the maximum score is 6 across the 30 items. It can also be scored on a facet level with a minimum score of 1 and a maximum score of 6 for the individual facet scored. A higher average score indicates higher psychological inflexibility.
Measured: Six weeks after participant consent
Psy-Flex
A 6-item measure assessing all facets of psychological flexibility using one item per facet. The minimum score is 6 and the maximum score is 30. Higher scores indicate higher psychological flexibility.
Measured: Measured immediately following participant consent to undertake survey
Psy-Flex
A 6-item measure assessing all facets of psychological flexibility using one item per facet. The minimum score is 6 and the maximum score is 30. Higher scores indicate higher psychological flexibility.
Measured: Six weeks after participant consent
Patient Health Questionnaire-9 (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 an additional item regarding how the depressive symptoms have interfered with everyday functioning. Higher scores indicate higher levels of everyday interference.
Measured: Measured immediately following participant consent to undertake survey
Patient Health Questionnaire-9 (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 an additional item regarding how the depressive symptoms have interfered with everyday functioning. Higher scores indicate higher levels of everyday interference.
Measured: Six weeks after participant consent
Pain Catastrophizing Scale (PCS)
A 13-item measure assessing the level of catastrophizing when in pain. Includes three main factors; rumination, magnification, and helplessness. The minimum score is 0 and the maximum score is 52. Higher scores indicate higher levels of pain catastrophizing.
Measured: Measured immediately following participant consent to undertake survey
Pain Catastrophizing Scale (PCS)
A 13-item measure assessing the level of catastrophizing when in pain. Includes three main factors; rumination, magnification, and helplessness. The minimum score is 0 and the maximum score is 52. Higher scores indicate higher levels of pain catastrophizing.
Measured: Six weeks after participant consent
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 ten items on pain interference will be used. Three out of the ten pain interference items, exploring how pain interferes with sexual activities, enjoyment of sex, and feelings of being rested, 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 three pain interference items created by the research team are scored in the same way.
Measured: Measured immediately following participant consent to undertake survey
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 ten items on pain interference will be used. Three out of the ten pain interference items, exploring how pain interferes with sexual activities, enjoyment of sex, and feelings of being rested, 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 three pain interference items created by the research team are scored in the same way.
Measured: Six weeks after participant consent
Endometriosis Health Profile - 5 (EHP-5)
A five-item measure assessing quality of life in people with endometriosis. Each item is scored on a four-point scale. The minimum score is 0, and the maximum score is 100. A higher score indicates worse health status. The measure is only administered to participants responding that they suffer from endometriosis.
Measured: Measured immediately following participant consent to undertake survey
Endometriosis Health Profile - 5 (EHP-5)
A five-item measure assessing quality of life in people with endometriosis. Each item is scored on a four-point scale. The minimum score is 0, and the maximum score is 100. A higher score indicates worse health status. The measure is only administered to participants responding that they suffer from endometriosis.
Measured: Six weeks after participant consent
Brief Pain inventory - short form (BPI-SF)
An eight-item questionnaire. One item measuring current pain intensity and seven items measuring pain interference on general activity, mood, sleep, feeling of being rested, relations with other people, enjoyment of life, and enjoyment of sex. The two items measuring pain interference on feelings of being rested and enjoyment of sex are developed by the research team. Item assessing sleep is administered once per day in the morning, and the item assessing feelings of being rested is administered once per day in the evening. Pain intensity is scored from 0 to 10, with 0 indicating the least amount of pain and 10 indicating the highest amount of pain. The 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. Administered twice daily for 42 days.
Measured: Six weeks
Patient Health Questionnaire-2 (PHQ-2)
A two-item version of the PHQ-9 made for assessing the level of interest and pleasure of doing things and, depression and hopelessness. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 20. Higher scores indicate higher levels of depression. Administered twice daily for 42 days.
Measured: Six weeks
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility
Six items from the MPFI measuring psychological inflexibility. Assessing the domains; experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 10. A higher average score indicates higher psychological inflexibility. Administered twice daily for 42 days.
Measured: Six weeks
Pain Catastrophizing Scale (PCS)
Three items from the PCS measuring the level of catastrophizing when in pain. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 30. Higher scores indicate higher levels of pain catastrophizing. Administered twice daily for 42 days.
Measured: Six weeks
Weekly events
A three-item measure developed by the research team to measure how the week has been in general, if something out of the ordinary has happened, and what this event was related to. The first item is from -10 to 10, with a higher score indicating a good week. The second item has five options and the third item has eight options for the participant to choose from. No summary score will be calculated, items are scored individually. Administered once a week for six weeks.
Measured: Six weeks
End of study questionnaire
An eight-item questionnaire developed by the research team assessing whether participants have begun any new treatment for their chronic pain condition, whether something out of the ordinary has happened during their study participation, and six items providing an opportunity for participants to give feedback on the study procedure, questionnaires, and platforms used in the current study.
Measured: Once approximately six weeks after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start5 Oct 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- 600 participants (estimated)
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
- NCT05518630
- Sponsor's protocol ID
- 20220516
- Status last verified
- Nov 2022
- First submitted
- 16 Aug 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
- ClinicalTrials.gov ID
- NCT05518630
- Acronym / sponsor ID
- 20220516
- Conditions
- Endometriosis, Vulvodynia, Fibromyalgia
- Keywords
- Endometriosis, Vulvodynia, Fibromyalgia, Psychological flexibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 26 Aug 2022 (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.
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. Despite the significant prevalence of all three conditions, they are receiving relatively little attention in psychological treatment research. Despite the popularity of methods that rely on aggregated group data, such as randomized controlled trials (RCTs), concerns have been raised in recent years about the generalizability of results from these methods to the individual level - group-to-individual generalizability. Since psychological treatments in the clinic are focused on enhancing the well-being of a specific individual this might affect how researchers should study these conditions. The current project aims to investigate: (a) item suitability for daily assessment of psychological variables, (b) group-to-individual generalizability in outcome measures frequently used in psychological studies and treatments of chronic pain, (c) relations over time between process and outcome variables, and (d) possible differences in results obtained across three pain conditions.
Detailed description
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. The pain conditions are associated with suffering both psychologically and physically. However, knowledge about these conditions is scarce.
The present study aims to investigate the relationship between pain intensity, psychological flexibility, pain functioning, catastrophizing, and depressive symptoms in people with endometriosis, vulvodynia, and fibromyalgia. The investigators want to investigate how these factors relate to each other over time, but also whether there is a difference between people who are in contact with health care for these conditions and those who are not, and whether there is a difference depending on which of the included pain conditions one has.
Another aim of the project is to investigate whether the variables the investigators intend to measure meet the criteria for group-to-individual generalizability, meaning that group means and correlation coefficients based on aggregated group data also apply to individuals and that it is reasonable to draw conclusions about individuals from group data. Many psychological variables do not meet the criteria for this type of generalizability. By examining whether the results from variables can be generalized from a group level to an individual level, the investigators will gain clues about how much individualization is required in future research, assessments, and treatments for the pain conditions included in the current project.
In order to investigate group-to-individual generalizability, the project requires a large sample of participants to obtain group averages but also a large number of repeated measurements over a longer period of time for each participant. Repeated measurements from each individual are planned to be carried out to obtain individual mean values, in order to compare this with the group data. A diary will be created which is intended to be used daily, and a further aim of this study is to evaluate whether this diary is valid to use for future studies in these pain conditions.
On the first day of the study, participants will complete forms collecting demographic and background information, including information about the participants' pain.
On the first as well as the last day, information will also be collected from standardized questionnaires, including the Multidimensional Psychological Flexibility Inventory (MPFI), Patient Health Questionnaire-9 (PHQ-9), Brief Pain Inventory (BPI), and Pain Catastrophizing Scale (PCS).
On the second day of the study, participants will start to fill in twice daily measures at fixed times, and with a 12-hour interval between these two daily measurements. These are based on an ecological momentary assessment approach (EMA), where frequently repeated measurements are taken in the natural environment of the research subjects and where the time that participants have to think back on when answering is kept short. Using EMA, the within-individual variation can be easily monitored over time. The daily measurements will be collected for 42 days. The measurements consist of items from MPFI, BPI, PHQ-2, and PCS. In addition, two items are developed by the research team to assess sexual functioning and energy levels.
Participants will also fill out a weekly diary administered six times in total. The weekly diary consists of three items asking the participant to rate the previous week, and indicate whether something out of the ordinary has happened.
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 reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia.
Key inclusion criteria (5 listed)
- Age 18 or over
- Reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia
- The pain condition present persistently or recurrently during ≥ 3 months
- Access to an internet-enabled smartphone/tablet
- Fluent in written Swedish
Key exclusion criteria (1 listed)
- Planned surgery during the upcoming 6 weeks
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 |
|---|---|---|
| Nomothetic Versus Idiographic Assessment in Chronic PainParticipants with either endometriosis, vulvodynia, and/or fibromyalgia will answer a twice-daily diary for 42 days and a short weekly diary six times in total. In addition, they will answer two longer surveys at the start and at the end of the 42 days. These questionnaires ask about psychological flexibility, depression, catastrophizing, and pain interference. The data collected is only observational and does not include any intervention. | Behavioural | – |
Primary outcome
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility subscale
Time frame: Measured immediately following participant consent to undertake survey
A 30-item measure reflecting all facets of psychological inflexibility, namely: experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The minimum score is an average of 1 across the 30 items, and the maximum score is 6 across the 30 items. It can also be scored on a facet level with a minimum score of 1 and a maximum score of 6 for the individual facet scored. A higher average score indicates higher psychological inflexibility.
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility subscale
Time frame: Six weeks after participant consent
A 30-item measure reflecting all facets of psychological inflexibility, namely: experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The minimum score is an average of 1 across the 30 items, and the maximum score is 6 across the 30 items. It can also be scored on a facet level with a minimum score of 1 and a maximum score of 6 for the individual facet scored. A higher average score indicates higher psychological inflexibility.
Psy-Flex
Time frame: Measured immediately following participant consent to undertake survey
A 6-item measure assessing all facets of psychological flexibility using one item per facet. The minimum score is 6 and the maximum score is 30. Higher scores indicate higher psychological flexibility.
Psy-Flex
Time frame: Six weeks after participant consent
A 6-item measure assessing all facets of psychological flexibility using one item per facet. The minimum score is 6 and the maximum score is 30. Higher scores indicate higher psychological flexibility.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Measured immediately following participant consent to undertake survey
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 an additional item regarding how the depressive symptoms have interfered with everyday functioning. Higher scores indicate higher levels of everyday interference.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Six weeks after participant consent
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 an additional item regarding how the depressive symptoms have interfered with everyday functioning. Higher scores indicate higher levels of everyday interference.
Pain Catastrophizing Scale (PCS)
Time frame: Measured immediately following participant consent to undertake survey
A 13-item measure assessing the level of catastrophizing when in pain. Includes three main factors; rumination, magnification, and helplessness. The minimum score is 0 and the maximum score is 52. Higher scores indicate higher levels of pain catastrophizing.
Pain Catastrophizing Scale (PCS)
Time frame: Six weeks after participant consent
A 13-item measure assessing the level of catastrophizing when in pain. Includes three main factors; rumination, magnification, and helplessness. The minimum score is 0 and the maximum score is 52. Higher scores indicate higher levels of pain catastrophizing.
Brief Pain inventory - short form (BPI-SF)
Time frame: Measured immediately following participant consent to undertake survey
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 ten items on pain interference will be used. Three out of the ten pain interference items, exploring how pain interferes with sexual activities, enjoyment of sex, and feelings of being rested, 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 three pain interference items created by the research team are scored in the same way.
Brief Pain inventory - short form (BPI-SF)
Time frame: Six weeks after participant consent
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 ten items on pain interference will be used. Three out of the ten pain interference items, exploring how pain interferes with sexual activities, enjoyment of sex, and feelings of being rested, 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 three pain interference items created by the research team are scored in the same way.
Endometriosis Health Profile - 5 (EHP-5)
Time frame: Measured immediately following participant consent to undertake survey
A five-item measure assessing quality of life in people with endometriosis. Each item is scored on a four-point scale. The minimum score is 0, and the maximum score is 100. A higher score indicates worse health status. The measure is only administered to participants responding that they suffer from endometriosis.
Endometriosis Health Profile - 5 (EHP-5)
Time frame: Six weeks after participant consent
A five-item measure assessing quality of life in people with endometriosis. Each item is scored on a four-point scale. The minimum score is 0, and the maximum score is 100. A higher score indicates worse health status. The measure is only administered to participants responding that they suffer from endometriosis.
Brief Pain inventory - short form (BPI-SF)
Time frame: Six weeks
An eight-item questionnaire. One item measuring current pain intensity and seven items measuring pain interference on general activity, mood, sleep, feeling of being rested, relations with other people, enjoyment of life, and enjoyment of sex. The two items measuring pain interference on feelings of being rested and enjoyment of sex are developed by the research team. Item assessing sleep is administered once per day in the morning, and the item assessing feelings of being rested is administered once per day in the evening. Pain intensity is scored from 0 to 10, with 0 indicating the least amount of pain and 10 indicating the highest amount of pain. The 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. Administered twice daily for 42 days.
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Six weeks
A two-item version of the PHQ-9 made for assessing the level of interest and pleasure of doing things and, depression and hopelessness. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 20. Higher scores indicate higher levels of depression. Administered twice daily for 42 days.
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility
Time frame: Six weeks
Six items from the MPFI measuring psychological inflexibility. Assessing the domains; experiential avoidance, lack of contact with the present moment, self as content, fusion, lack of contact with values, and inaction. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 10. A higher average score indicates higher psychological inflexibility. Administered twice daily for 42 days.
Pain Catastrophizing Scale (PCS)
Time frame: Six weeks
Three items from the PCS measuring the level of catastrophizing when in pain. The items are scored from 0 to 10. The minimum score is 0 and the maximum score is 30. Higher scores indicate higher levels of pain catastrophizing. Administered twice daily for 42 days.
Weekly events
Time frame: Six weeks
A three-item measure developed by the research team to measure how the week has been in general, if something out of the ordinary has happened, and what this event was related to. The first item is from -10 to 10, with a higher score indicating a good week. The second item has five options and the third item has eight options for the participant to choose from. No summary score will be calculated, items are scored individually. Administered once a week for six weeks.
End of study questionnaire
Time frame: Once approximately six weeks after intake
An eight-item questionnaire developed by the research team assessing whether participants have begun any new treatment for their chronic pain condition, whether something out of the ordinary has happened during their study participation, and six items providing an opportunity for participants to give feedback on the study procedure, questionnaires, and platforms used in the current study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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 Endometriosis and Vulvodynia, 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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Buhrman, PhD (0046184712126, monica.buhrman@psyk.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Psychological Flexibility Inventory (MPFI) - Psychological Inflexibility subscale (time frame: Measured immediately following participant consent to undertake survey). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.