Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions

Virtual Single-Session "Empowered Relief" Class for Individuals With Marfan Syndrome and Related Conditions

Empowered Relief (ER) is a 1-session pain relief skills intervention that is delivered in-person or online by certified clinicians to groups of patients with acute or chronic pain. Prior work in has shown ER efficacy for reducing chronic pain, pain-related distress, and other symptoms 6 months post-treatment. The purpose of this study is to conduct the first feasibility and early efficacy test of online ER (two hours total treatment time) delivered to individuals with Marfan syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, and related conditions. Participants will be followed for 3 months via 5 follow-up surveys.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Marfan Syndrome; Vascular Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome
• Intervention / Treatment: Behavioral: Empowered Relief

Detailed Description

The investigators will implement a single arm online feasibility and preliminary efficacy trial of a pain relief skills intervention "Empowered Relief" to reduce pain metrics for individuals with Marfan syndrome and related conditions. Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure pain intensity and symptom status at: baseline, immediately post-treatment; at post-treatment week 2 and months 1, 2, and 3. The study primary endpoint is change in pain intensity or pain interference from baseline to 1 month follow-up (short-term efficacy).

Online delivery of evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with Marfan syndrome and related conditions and associated chronic pain. Results from this study will fill several critical gaps in evidence for pain care in this population. This study will provide a low-cost, low-risk, widely available and feasible protocol that may help address the needs of patients living with Marfan and related syndromes.

Aim 1: Test the feasibility of live, online group-based ER.

Hypothesis 1a: Outcome 1, participant ratings will be >80% for the 7-item treatment appraisal/satisfaction measure administered immediately after completion of ER.

Hypothesis 1b: Outcome 2, ER attendance will be >70%.

Aim 2 (preliminary efficacy): Reduce multi-primary outcomes (pain intensity or pain interference) and secondary outcomes at 3 month post-treatment.

Hypothesis 2a: Outcome 3, Improvement of pain intensity or pain interference from baseline to 3 month follow-up (multi-primary study endpoint).

Hypothesis 2b: Outcome 4, Improvement of 4 priority secondary outcomes (sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety) from baseline to 3 month follow-up.

Hypothesis 2c: Outcome 5, Improvement of other secondary outcomes (satisfaction with social roles and responsibilities, anger, fatigue, and depression) from baseline to 3 month follow-up. Patient outcomes will be longitudinally tracked after the intervention session for participants.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne Jung, PhD; Phone Number: 650-724-0522; Email: cejung@stanford.edu
• Study Contact Backup: Name: Beth Darnall, PhD; Phone Number: 650-723-2040; Email: bdarnall@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Beth Darnall, Ph.D.
      • Principal Investigator: Beth Darnall, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and females 18 years of age or older
• Marfan Syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome or related connective tissue disease and chronic pain
• English fluency
• Ability to adhere to and complete study protocols

Exclusion Criteria:

• Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1-Session pain relief skills class (online Empowered Relief); Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.

Behavioral: Empowered Relief; The participants will attend an online pain relief skills intervention (Empowered Relief). The two-hour group session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.; Other Names: 1-Session Pain Relief Skills Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants registered for class	Full registration for the online session (N=100)	baseline
Class Attendance	At least 70% attendance for the registered Empowered Relief online class	at treatment
Treatment appraisal	7 items assess treatment appraisal/satisfaction using 7-point scales (0-6) where higher ratings represent greater appraisal/satisfaction with the treatment. The investigators hypothesize >=80% ratings for treatment appraisal/satisfaction rated immediately post-treatment.	immediately post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Group pre-post changes at 3 months with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.	post-treatment month 3
Pain Intensity	Group pre-post reductions at 3 months with the Patient Reported Outcomes Measurement Systems (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity.	post-treatment month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Group pre-post changes at 1 month with the Pain Catastrophizing 13-item scale quantifying an individual's pain experience. Reponses range from 0 = "Not at all" and 4 = "All the time". Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.	post-treatment month 1
Pain Bothersomeness	Group pre-post changes at 3 months with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = "Not at all bothersome" to 10 = "Extremely bothersome" where higher scores represent a greater degree of pain bothersomeness.	post-treatment month 3
Pain Bothersomeness	Group pre-post changes at 1 month with the Pain Bothersomeness 1-item scale assessing pain bothersomeness over the past 7 days. Responses range from 0 = "Not at all bothersome" to 10 = "Extremely bothersome" where higher scores represent a greater degree of pain bothersomeness.	post-treatment month 1
Pain Self-Efficacy Questionnaire	Group pre-post changes at 3 months with the Pain Self-Efficacy Questionnaire 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning.	post-treatment month 3
Pain Self-Efficacy Questionnaire	Group pre-post changes at 1 month with the Pain Self-Efficacy 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning.	post-treatment month 1
Pain Intensity	Group pre-post reductions at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Intensity 1-item scale assessing average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity.	post-treatment month 1
Pain Interference	Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference.	post-treatment month 3
Pain Interference	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference.	post-treatment month 1
Sleep Disturbance	Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.	post-treatment month 3
Sleep Disturbance	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 6-item scale assessing sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.	post-treatment month 1
Fatigue	Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue.	post-treatment month 3
Fatigue	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Fatigue 8-item scale assessing fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue.	post-treatment month 1
Satisfaction with Participation in Social Roles	Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction.	post-treatment month 3
Satisfaction with Participation in Social Roles	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Satisfaction with Participation in Social Roles 7-item scale assessing satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction.	post-treatment month 1
Depression	Group pre-post changes at 3 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.	post-treatment month 3
Depression	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Depression 6-item scale assessing negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.	post-treatment month 1
Anxiety	Group pre-post changes at 3 months with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety.	post-treatment month 3
Anxiety	Group pre-post changes at 1 month with the Patient Reported Outcomes Measurement Outcomes System (PROMIS) Anxiety 6-item scale assessing fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety.	post-treatment month 1
Anger	Anger: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anger 5-item scale assesses anger over the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent a greater degree of anger.	post-treatment month 1
Anger	Anger: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anger 5-item scale assesses anger over the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent a greater degree of anger.	post-treatment month 3

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: The Marfan Foundation
• Investigators: Principal Investigator: Beth Darnall, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Pain; Neurologic Manifestations; Disease; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Bone Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Skin Abnormalities; Abnormalities, Multiple; Bone Diseases, Developmental; Limb Deformities, Congenital; Aneurysm; Aortic Diseases; Collagen Diseases; Aortic Aneurysm; Dissection, Blood Vessel; Aortic Dissection; Syndrome; Chronic Pain; Marfan Syndrome; Arachnodactyly; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; Ehlers-Danlos Syndrome, Type IV
• Other Study ID Numbers: 68906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No