Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain

NCT06285864 | Completed

• 1 other identifier: 122/2023
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Musculoskeletal Pain; Chronic Pain

Keywords

interoception; musculoskeletal pain; feasibility

Outcome Measures

Primary Outcomes (5)

• 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.

• 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)

• 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

• 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

• 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 Outcomes (9)

• Interoceptive sensibility

  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).

• 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).

• 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).

• Pain-related self-efficacy

  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).

• 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).

Study Arms (2)

Interoception-based intervention

EXPERIMENTAL

The interoception-based intervention group will receive the intervention, which consists of 8 weekly sessions, of 1h30 hour, in groups (4-8 participants in each group).

Behavioral: Interoception-based intervention

Waiting list

NO INTERVENTION

The waiting list group will maintain their treatments as usual and receive the interoception-based intervention, at the end of the study.

Interventions

Interoception-based intervention BEHAVIORAL

Intervention will include body awareness, sensorial, and relaxation exercises, plus homework.

Interoception-based intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• neurodegenerative diseases
• cancer pain
• recent fractures, or surgeries (\< 3 months).

Sponsors & Collaborators

• Iscte-University Institute of Lisbon: lead
• Foundation for Science and Technology, Portugal: collaborator
• University of Évora: collaborator

Study Sites (2)

Iscte - University Institute of Lisbon

Lisbon, Lisbon District, 1649-026, Portugal

Location

University of Évora

Evora, Évora District, 7004-516, Portugal

Location

Related Publications (25)

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• 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

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MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Inês Oliveira, MSc

  Iscte-University Institute of Lisbon

  PRINCIPAL INVESTIGATOR

• Sónia Bernardes, PhD

  Iscte-University Institute of Lisbon

  STUDY CHAIR

• Margarida Garrido, PhD

  Iscte-University Institute of Lisbon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 29, 2024
• Study Start: February 11, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 30, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study publication.
• Access Criteria: Researchers interested in accessing the IPD for further analysis or collaboration should submit a formal request to the authors. Requests will be evaluated based on ethical considerations, data access criteria, and adherence to data use agreements.

Locations

PT (2)