Empowered Relief for Youth

Not Applicable

Recruiting

• Conditions: Fibromyalgia; Abdominal Pain; Chronic Pain; Neuropathic Pain; Musculoskeletal Pain; Complex Regional Pain Syndromes
• Interventions: Behavioral: Empowered Relief for Youth

• Registration Number: NCT05998369
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.

Detailed Description

The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.

Study Timeline

• Study Start: 2023-08-09
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-08
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age at least 10 years old to 18 years
• Diagnosis of Chronic Pain
• English speaking

Exclusion Criteria

• Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
• Severe affective disorder (e.g., severe depression/ anxiety) from medical record review.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Empowered Relief for Youth	Empowered Relief for Youth	Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.

Primary Outcome Measures

Name	Time	Method
Treatment Expectancy Credibility (TEC-C)	Immediately post class	The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.
Program Feedback Scale	Immediately post class	The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS)	Pre class, 4 weeks, 8 weeks, and 12 weeks post class	The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.
Patient Global Impression of Change (PGIC)	4 weeks, 8 weeks, and 12 weeks post class	The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = "very much improved" to 6 = "very much worse") with higher scores indicating greater severity to their pain.
PROMIS Pain Interference	Pre class, 4 weeks, 8 weeks, and 12 weeks post class	The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = "never" to 4 = "almost always") with a higher score indicating great pain interference.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States