青少年慢性肌肉骨骼疼痛的复原力指导：促进压力管理中的复原力（PRISM）的一项试点随机对照试验方案

Resilience Coaching for Adolescent Chronic Musculoskeletal Pain: Protocol for a Pilot Randomized Controlled Trial of Promoting Resilience in Stress Management (PRISM).

作者信息

Gmuca Sabrina, McGill Mackenzie, Butler Nellie, Xiao Rui, Cronholm Peter F, Young Jami F, Palermo Tonya M, Weiss Pamela F, Rosenberg Abby R

机构信息

Division of Rheumatology, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.

Clinical Futures, Children's Hospital of Philadelphia, Philadelphia, PA, United States.

出版信息

JMIR Res Protoc. 2025 Jul 22;14:e73385. doi: 10.2196/73385.

DOI:10.2196/73385

PMID:40694836

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12326160/

Abstract

BACKGROUND

Levels of self-perceived psychological resilience are low to moderate among youth with chronic musculoskeletal pain (CMP). Furthermore, resilience has been associated with symptom severity in CMP. Resilience coaching programs may therefore be of benefit in the nonpharmacologic management of adolescent CMP and may serve as an adjunctive way to access mental health services in an approachable and affordable way.

OBJECTIVE

The main goal of the study is to assess the feasibility, acceptability, and preliminary efficacy of the resilience coaching program called Promoting Resilience in Stress Management (PRISM) and to obtain the data needed to plan a larger trial.

METHODS

The Resilience Coaching for Adolescents with Chronic Musculoskeletal Pain pilot study is an investigator initiated, 2-arm, randomized controlled trial (RCT) of PRISM in the interdisciplinary management of CMP among adolescents. The study will compare usual care versus PRISM+usual care among adolescents newly diagnosed with CMP in the outpatient setting. One caregiver per patient will also be enrolled. The control group will receive usual care with no specific intervention. The treatment arm will receive PRISM, which is a remotely delivered, 1-on-1resilience coaching program, consisting of 4 required skill-based sessions and an optional final session. Sessions will be delivered every 1-2 weeks, lasting about 3 months in total. The primary outcome is the Functional Disability Inventory (FDI) score at 3 months postrandomization. The secondary objectives are to evaluate potential patient- and caregiver-level moderators of PRISM and identify facilitators of and barriers to engagement in PRISM. The estimated sample size is 65 patient-caregiver dyads per group, for a total of 130 dyads.

RESULTS

The trial is currently open. Initial Institutional Review Board approval was obtained on April 4, 2023, and protocol version 4 was amended on January 14, 2025. Recruitment began on May 8, 2023, and recruitment is anticipated to be completed on August 1, 2025.

CONCLUSIONS

Resilience coaching has demonstrated excellent feasibility, acceptability, and efficacy in teenagers with chronic illness; however, evidence to support its use in adolescent CMP is lacking. Resilience coaching has the potential to improve patient outcomes in this population. This pilot RCT will demonstrate acceptability, feasibility, and preliminary efficacy and reveal critical barriers to and facilitators of engagement. This will inform a larger multisite trial to evaluate the definitive efficacy of the intervention.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05834725; https://clinicaltrials.gov/study/NCT05834725.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73385.

摘要

背景

慢性肌肉骨骼疼痛（CMP）青少年的自我感知心理复原力水平处于低至中等程度。此外，复原力与CMP的症状严重程度相关。因此，复原力指导计划可能有助于青少年CMP的非药物管理，并且可以作为一种以平易近人和经济实惠的方式获得心理健康服务的辅助途径。

目的

本研究的主要目标是评估名为“促进压力管理中的复原力”（PRISM）的复原力指导计划的可行性、可接受性和初步疗效，并获取规划更大规模试验所需的数据。

方法

“慢性肌肉骨骼疼痛青少年的复原力指导”试点研究是一项由研究者发起的双臂随机对照试验（RCT），旨在研究PRISM在青少年CMP跨学科管理中的作用。该研究将比较门诊新诊断为CMP的青少年接受常规护理与PRISM+常规护理的效果。每位患者还将招募一名护理人员。对照组将接受无特定干预的常规护理。治疗组将接受PRISM，这是一个远程提供的一对一复原力指导计划，包括4次基于技能的必修课和1次选修课。课程每1-2周进行一次，总共持续约3个月。主要结局是随机分组后3个月时的功能障碍量表（FDI）评分。次要目标是评估PRISM潜在的患者和护理人员层面的调节因素，并确定参与PRISM的促进因素和障碍。估计样本量为每组65对患者-护理人员，共130对。