Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain

Chronic Pain Clinical Trial

Official title:

Sense to Act: Randomized-controlled Trial of an Interoceptive Sensibility Intervention for Musculoskeletal Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285864
• Other study ID #: 122/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Iscte-University Institute of Lisbon
• Contact: Inês Oliveira, MSc
• Phone: +351217903000
• Email: iamoa[@]iscte-iul.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (< 3 months).

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Behavioral:
• Interoception-based intervention
Intervention will include body awareness, sensorial, and relaxation exercises, plus homework.

Locations

Country	Name	City	State
Portugal	University of Évora	Évora
Portugal	Iscte - University Institute of Lisbon	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Iscte-University Institute of Lisbon	Foundation for Science and Technology (FCT), University of Évora

Country where clinical trial is conducted

Portugal, 

References & Publications (25)

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.

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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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

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. — View 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.

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. — View 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. — View 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. — View 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. — View 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

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. — View 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. — View 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.

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

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

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

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. — View 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Sessions' acceptability	Session evaluation checklist - 7 questions answered on a 5-point scale ranging from 1 (totally disagree) to 5 (completely agree), plus 1 open question asking for improvement suggestions.	Up to 24 hours after each intervention session.
Primary	Feasibility - Program acceptability, appropriateness, and feasibility	Program evaluation checklist: 21 questions answered on a 5-point scale ranging from 1 (totally disagree) to 5 (completely agree) plus 3 open questions.	Up to 72 hours after the end of the intervention (T2)
Primary	Feasibility - Recruitment, retention, and attendance rates	Number of participants recruited, number of participants included in the study (among those who are eligible), and average number of sessions attended in intervention by participants.	Up to 12 weeks after the end of the intervention
Primary	Feasibility - safety/unexpected events	Number and type of unexpected events reported by the participants during their participation in the intervention.	Up to 12 weeks after the end of the intervention
Primary	Feasibility - Treatment Fidelity Check	Sessions will be audio-recorded and an independent therapist will confirm if planned procedures were done.	Up to 12 weeks after the end of the intervention.
Secondary	Interoceptive sensibility	Multidimensional Assessment of Interoceptive Awareness assesses IS skills, such as identifying bodily sensations, body-mind relationships, and body trust, through 32 items rated on a 6-point Likert scale. Higher scores expresses higher IS levels.	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).
Secondary	Psychological flexibility	The Portuguese Comprehensive Assessment of Acceptance and Commitment Therapy Processes is an 18-item scale that measures psychological flexibility (openness to experience, behavioral awareness, valued action) on a 7-point rating scale. Higher scores indicate greater psychological flexibility.	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).
Secondary	Emotion regulation	Difficulties in Emotion Regulation Scale - Short Form assesses difficulties in emotion regulation (e.g., nonacceptance of emotional responses, difficulty engaging in goal-directed behavior or in impulse control, lack of emotional awareness), through 18 items. Higher scores correspond to more difficulty in emotion regulation.	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).
Secondary	Pain-related self-efficacy	The Pain Self-Efficacy Questionnaire assesses the individuals' confidence level in reaching activities or goals, despite pain with 10 items rated on a 7-point scale. Higher scores represent higher self-efficacy levels.	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).
Secondary	Pain catastrophizing	Pain Catastrophizing Scale measures pain-related catastrophic thinking through 13 items rated on a 5-point scale.Higher levels express higher levels of pain catastrophizing.	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).
Secondary	Activity patterns	Activity Patterns Scale measures activity patterns through 24 questions responded to on a 5-point scale (avoidance, persistence, and pacing related patterns). Higher levels represent more use of the respective pattern.	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).
Secondary	Affective distress (depression and anxiety)	Depression Anxiety Stress Scales evaluate depression/anxiety/stress levels experienced during the previous week, through 21 items rated on a 4-point scale. Higher levels represent higher depression and anxiety levels.	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).
Secondary	Pain severity	Brief Pain Inventory assesses pain-related disability (e.g., general activities, walking, work, mood) through 7 items rated on 11-point numerical scales; Graded Chronic Pain Scale-Revised (Von Korff et al., 2020) identify chronic pain individuals, grading their pain severity, through 6 items.	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).
Secondary	Physical function and Vitality	Medical Outcomes Study-36 - Short Form 36v2 assesses functional limitations in daily physical activities, and vitality, through 10 and 4 items, rated on 4 and 5-point scales, respectively. Higher scores correspond to higher physical function and vitality.	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).