An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain

NCT05518630 | Unknown

• 1 other identifier: 20220516
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Vulvodynia; Fibromyalgia

Keywords

Endometriosis; Vulvodynia; Fibromyalgia; Psychological flexibility

Outcome Measures

Primary Outcomes (18)

• 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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Once approximately six weeks after intake

Interventions

Nomothetic Versus Idiographic Assessment in Chronic Pain BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia.

You may qualify if:

• 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

You may not qualify if:

• \- Planned surgery during the upcoming 6 weeks

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of Psychology, Uppsala University

Uppsala, Uppland, 75236, Sweden

RECRUITING

MeSH Terms

Conditions

Endometriosis; Vulvodynia; Fibromyalgia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Monica Buhrman, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Buhrman, PhD

CONTACT

0046184712126; monica.buhrman@psyk.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 26, 2022
• Study Start: October 5, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

SE (1)