Sense to Act: Pilot Randomized-controlled Trial of an Interoceptive Sensibility Intervention for Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Feasibility - Sessions' acceptability
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be unaware of their assigned treatment.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals (over 18 years old)
- •experiencing chronic musculoskeletal pain (≥ 3 months)
- •able to understand and speak portuguese
排除标准
- •neurodegenerative diseases
- •cancer pain
- •recent fractures, or surgeries (< 3 months).
结局指标
主要结局
Feasibility - Sessions' acceptability
时间窗: Up to 24 hours after each intervention session.
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.
Feasibility - Recruitment, retention, and attendance rates
时间窗: Up to 12 weeks after the end of the intervention
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.
Feasibility - Treatment Fidelity Check
时间窗: Up to 12 weeks after the end of the intervention.
Sessions will be audio-recorded and an independent therapist will confirm if planned procedures were done.
Feasibility - Program acceptability, appropriateness, and feasibility
时间窗: Up to 72 hours after the end of the intervention (T2)
Program evaluation checklist: 21 questions answered on a 5-point scale ranging from 1 (totally disagree) to 5 (completely agree) plus 3 open questions.
Feasibility - safety/unexpected events
时间窗: Up to 12 weeks after the end of the intervention
Number and type of unexpected events reported by the participants during their participation in the intervention.
次要结局
- 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 severity(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).)
- 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).)
- 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).)
- Activity patterns(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).)
- Affective distress (depression and anxiety)(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).)
- 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).)
- 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).)
研究者
Ines Oliveira
MSc
Iscte-University Institute of Lisbon
