Empowered Relief for Youth (ER-Y)

• ClinicalTrials.gov Identifier: NCT05998369
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: August 25, 2023
• Sponsor: Stanford University
• Information provided by (Responsible Party): Laura E Simons, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Neuropathic Pain; Complex Regional Pain Syndromes; Abdominal Pain	Behavioral: Empowered Relief for Youth	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
• Actual Study Start Date: August 9, 2023
• Estimated Primary Completion Date: August 2025
• Estimated Study Completion Date: November 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Behavioral: Empowered Relief for Youth; The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.

Outcome Measures

Primary Outcome Measures :

1. Treatment Expectancy Credibility (TEC-C) [ Time Frame: 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.
2. Program Feedback Scale [ Time Frame: 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 :

1. PROMIS Pain Interference [ Time Frame: 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.
2. Patient Global Impression of Change (PGIC) [ Time Frame: 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.
3. Pain Catastrophizing Scale (PCS) [ Time Frame: 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.

Other Outcome Measures:

1. Child Pain Self-Efficacy Scale (PSES-C) [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]
   The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = "very sure" to 5 = "very unsure") with higher scores indicating enhanced uncertainty.
2. PROMIS Anxiety [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]
   The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater experience to anxiety.
3. PROMIS Depression [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]
   The PROMIS depression study assesses symptoms related to depression within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater depressive symptoms.
4. Hope Scale [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]
   The Hope Scale assess the participant's hope level based on a ranked scale (score 1 = "definitely false" to 8 = "definitely true") with a higher score indicating highly hopeful.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Dylan Mayanja, BA; 650-736-2945; dmayanja@stanford.edu

Contact: Jeremy Giberson, MAS; jgiberso@stanford.edu

Locations

United States, California

Stanford University; Recruiting

Palo Alto, California, United States, 94304

Principal Investigator: Laura Simons, PhD

Sub-Investigator: Lauren Harrison, PhD

Sub-Investigator: Rashmi Bhandari, PhD

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Laura Simons, PhD; Stanford University

More Information

• Responsible Party: Laura E Simons, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05998369
• Other Study ID Numbers: 68451
• First Posted: August 21, 2023
• Last Update Posted: August 25, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fibromyalgia; Musculoskeletal Pain; Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Chronic Pain; Abdominal Pain; Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Signs and Symptoms, Digestive; Autonomic Nervous System Diseases