Clinical trial NCT06285864: Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain
Official title: Sense to Act: Randomized-controlled Trial of an Interoceptive Sensibility Intervention for Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Pain
Keywords: interoception
musculoskeletal pain
feasibility
Lead sponsor: Iscte-University Institute of Lisbon
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
name: University of Évora
First posted: 2024-02-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients.

Detailed description: Background: Interoceptive sensibility (IS), the self-reported experience of internal states, involves individuals' capacity to sense, interpret, integrate, and regulate their own bodily information. Disruptions in interoceptive processes are often associated with various health conditions, including mental illness and chronic pain (CP). Individuals with chronic musculoskeletal pain present disruptions in IS associated with worse pain adjustment.

While there is a growing body of research testing interoceptive-based interventions on both healthy and clinical samples, interventions specifically tailored for individuals with CP are limited. Furthermore, despite evidence that interventions such as mindfulness or meditation improve IS in incividuals with CP, the mechanisms contributing to enhanced pain-related outcomes remain unknown. Additionally, in Portugal, there is a lack of cost-effective interventions for CP in both public health services and the community.

This study aims to address these gaps by evaluating the feasibility of a program designed for a community setting. The program is specifically developed to enhance IS, potentially improving pain adjustment in individuals with chronic musculoskeletal pain - one of the most prevalent and burdensome types of pain globally. The study compares a group receiving an interoception-based intervention, intending to improve IS, against a control group on a waiting list, examining the intervention's acceptability, feasibility, appropriateness, and estimated treatment effects.

Method: The recruitment process will be conducted through the study website, providing information about the research team, study objectives, and general details about the intervention structure and session schedules. Potential participants must register on the website to enroll in the study. Measurements will be collected anonymously and online (via Qualtrics) using self-report questionnaires at four points in time: before (T0), in the middle (T1), at the end (T2), and one month after the intervention (T3). Additionally, participants in the intervention group will complete an anonymous evaluation checklist after each session and a final evaluation checklist assessing the study's acceptability, appropriateness, and feasibility. Block-stratified randomization of participants for each group (intervention/control), based on sex and geographical area (Lisbon/Évora), will be conducted using randomization software.

The intervention includes four stages addressing different IS skills with 8 weekly sessions (4-6 participants), each lasting 1.5 hours. These sessions will be delivered by two trained psychomotor therapists with clinical experience, supplemented by daily home exercises. To ensure fidelity of the procedures during sessions, recordings will be made for later review (therapists cross-confirm each other's sessions).

Discussion: It is expected that, with or without protocol modifications: 1) The protocol components are suitable to conduct a larger study; 2) the program has good acceptability, appropriateness, feasibility, and participant adherence.

Eligibility criteria: Inclusion Criteria:

* Adult individuals (over 18 years old)
* experiencing chronic musculoskeletal pain (≥ 3 months)
* able to understand and speak portuguese

Exclusion Criteria:

* neurodegenerative diseases
* cancer pain
* recent fractures, or surgeries (\&lt; 3 months).

Primary outcomes:
measure: Feasibility - Sessions' acceptability
timeFrame: Up to 24 hours after each intervention session.
measure: Feasibility - Program acceptability, appropriateness, and feasibility
timeFrame: Up to 72 hours after the end of the intervention (T2)
measure: Feasibility - Recruitment, retention, and attendance rates
timeFrame: Up to 12 weeks after the end of the intervention
measure: Feasibility - safety/unexpected events
timeFrame: Up to 12 weeks after the end of the intervention
measure: Feasibility - Treatment Fidelity Check
timeFrame: Up to 12 weeks after the end of the intervention.
Secondary outcomes:
measure: Interoceptive sensibility
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Psychological flexibility
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Emotion regulation
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Pain-related self-efficacy
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Pain catastrophizing
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Activity patterns
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Affective distress (depression and anxiety)
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Pain severity
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
measure: Physical function and Vitality
timeFrame: Within the 72-hour period before the first session (T0); up to 72 hours after the fourth session (T1), up to 72 hours after the last (eighth) session (T2), and one month after the last session (T3).
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Iscte - University Institute of Lisbon
city: Évora
country: Portugal
facility: University of Évora
Study officials:
affiliation: Iscte-University Institute of Lisbon
name: Inês Oliveira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Iscte-University Institute of Lisbon
name: Sónia Bernardes, PhD
role: STUDY_CHAIR
affiliation: Iscte-University Institute of Lisbon
name: Margarida Garrido, PhD
role: STUDY_CHAIR
References:
citation: Ferreira PL. [Development of the Portuguese version of MOS SF-36. Part I. Cultural and linguistic adaptation]. Acta Med Port. 2000 Jan-Apr;13(1-2):55-66. Portuguese.
citation: Ferreira PL. [Development of the Portuguese version of MOS SF-36. Part II --Validation tests]. Acta Med Port. 2000 May-Jun;13(3):119-27. Portuguese.
citation: Sullivan, M. J. L., Bishop, S. R., &amp;amp; Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 7(4), 524-532. https://doi.org/10.1037/1040-3590.7.4.524
citation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Psychometric properties of the portuguese version of the Pain Self-Efficacy Questionnaire. Acta Reumatol Port. 2011 Jul-Sep;36(3):260-7.
citation: Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment. 2016;38(3):443-455. doi: 10.1007/s10862-015-9529-3.
citation: Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
citation: Azevedo LF, Altamiro CP, Cláudia D, Luís A, Laurinda L, José R, Teresa P, Sílvia VS, Rosário A, Carlos JC, Maria CC, Duarte C, José C, Georgina C, Beatriz CL, Maria CL, Beatriz S, José CL. Tradução, adaptação cultural e estudo multicêntrico de validação de instrumentos para rastreio e avaliação do impacto da dor crónica. Dor 2007;15:6-56.
citation: Cleeland CS. Measurement of pain by subjective report. Advances in pain research and therapy: issues in pain measurement. Vol. 12. New York, NY: Raven Press, 1989. p. 391-403.
citation: Pais-Ribeiro J, Honrado A, Leal I. Contribuição para o estudo da adaptação portuguesa das Escalas de Ansiedade, Depressão e Stress (EADS) de 21 itens de Lovibond e Lovibond. Psicol Saúde Doenc¸ as 2004; 5:229-39.
citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
citation: Von Korff M, DeBar LL, Krebs EE, Kerns RD, Deyo RA, Keefe FJ. Graded chronic pain scale revised: mild, bothersome, and high-impact chronic pain. Pain. 2020 Mar;161(3):651-661. doi: 10.1097/j.pain.0000000000001758.
citation: Esteve R, Ramirez-Maestre C, Peters ML, Serrano-Ibanez ER, Ruiz-Parraga GT, Lopez-Martinez AE. Development and Initial Validation of the Activity Patterns Scale in Patients With Chronic Pain. J Pain. 2016 Apr;17(4):451-61. doi: 10.1016/j.jpain.2015.12.009. Epub 2015 Dec 23.
citation: Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
citation: Machorrinho J, Veiga G, Fernandes J, Mehling W, Marmeleira J. Multidimensional Assessment of Interoceptive Awareness: Psychometric Properties of the Portuguese Version. Percept Mot Skills. 2019 Feb;126(1):87-105. doi: 10.1177/0031512518813231. Epub 2018 Nov 19.
citation: Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.
citation: Oliveira I, Garrido MV, Bernardes SF. On the body-mind nexus in chronic musculoskeletal pain: A scoping review. Eur J Pain. 2022 Jul;26(6):1186-1202. doi: 10.1002/ejp.1944. Epub 2022 Apr 4.
citation: Bonaz B, Lane RD, Oshinsky ML, Kenny PJ, Sinha R, Mayer EA, Critchley HD. Diseases, Disorders, and Comorbidities of Interoception. Trends Neurosci. 2021 Jan;44(1):39-51. doi: 10.1016/j.tins.2020.09.009.
citation: Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.
citation: Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.
citation: Chen WG, Schloesser D, Arensdorf AM, Simmons JM, Cui C, Valentino R, Gnadt JW, Nielsen L, Hillaire-Clarke CS, Spruance V, Horowitz TS, Vallejo YF, Langevin HM. The Emerging Science of Interoception: Sensing, Integrating, Interpreting, and Regulating Signals within the Self. Trends Neurosci. 2021 Jan;44(1):3-16. doi: 10.1016/j.tins.2020.10.007.
citation: Moreira, H., Gouveia, M. J., & Canavarro, M. C. (2022). A bifactor analysis of the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) in a sample of adolescents and adults. Current Psychology, 41(2), 757-782. https://doi.org/10.1007/s12144-019-00602-5
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
citation: Trindade, I. A., Ferreira, N. B., Mendes, A. L., Ferreira, C., Dawson, D., & Golijani-Moghaddam, N. (2021). Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT): Measure refinement and study of measurement invariance across Portuguese and UK samples. Journal of Contextual Behavioral Science, 21, 30-36. https://doi.org/10.1016/j.jcbs.2021.05.002
citation: Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145. https://doi.org/10.1016/j.jcbs.2016.05.003
citation: Trindade, I. A., Vagos, P., Moreira, H., Fernandes, D. V., & Tyndall, I. (2022). Further validation of the 18-item Portuguese CompACT scale using a multi-sample design: Confirmatory factor analysis and correlates of psychological flexibility. Journal of Contextual Behavioral Science, 25, 1-9. https://doi.org/10.1016/j.jcbs.2022.06.003