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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a feasibility clinical trial by implementing a 1-session pain relief skills intervention (Empowered Relief; two hours total treatment time) for individuals with Marfan syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, and related conditions.

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. 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.

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

Conditions
-----------------
Chronic Pain, Marfan Syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome

Intervention / Treatment
-----------------
* Behavioral: Empowered Relief


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief<br>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<br>* A certified instructor delivers 1 online session of a pain relief skills intervention (Empowered Relief) to one group of patients<br>|

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 | 60% attendance rate (N=60) | at treatment | 
| Treatment appraisal | 8 items assess satisfaction and perceived utility of assigned treatment using 7 and 11-point scales where higher ratings represent greater satisfaction with the treatment. We aim to achieve 80% ratings for treatment satisfaction (combined items) rated immediately post-treatment. | immediately post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |