Clinical trial NCT05980104: Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions
Official title: Virtual Single-Session "Empowered Relief" Class for Individuals with Marfan Syndrome and Related Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Marfan Syndrome
Vascular Ehlers-Danlos Syndrome
Loeys-Dietz Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Marfan Foundation
First posted: 2023-08-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Number of participants registered for class
timeFrame: baseline
measure: Class Attendance
timeFrame: at treatment
measure: Treatment appraisal
timeFrame: immediately post-treatment
Secondary outcomes:
measure: Pain Intensity
timeFrame: post-treatment month 3
measure: Pain Catastrophizing
timeFrame: post-treatment month 3
Other outcomes:
measure: Pain Intensity
timeFrame: post-treatment month 1
measure: Pain Catastrophizing
timeFrame: post-treatment month 1
measure: Pain Interference
timeFrame: post-treatment month 3
measure: Pain Interference
timeFrame: post-treatment month 1
measure: Sleep Disturbance
timeFrame: post-treatment month 3
measure: Sleep Disturbance
timeFrame: post-treatment month 1
measure: Pain Bothersomeness
timeFrame: post-treatment month 3
measure: Pain Bothersomeness
timeFrame: post-treatment month 1
measure: Fatigue
timeFrame: post-treatment month 3
measure: Fatigue
timeFrame: post-treatment month 1
measure: Satisfaction with Participation in Social Roles
timeFrame: post-treatment month 3
measure: Satisfaction with Participation in Social Roles
timeFrame: post-treatment month 1
measure: Pain Self-Efficacy Questionnaire
timeFrame: post-treatment month 3
measure: Pain Self-Efficacy Questionnaire
timeFrame: post-treatment month 1
measure: Depression
timeFrame: post-treatment month 3
measure: Depression
timeFrame: post-treatment month 1
measure: Anxiety
timeFrame: post-treatment month 3
measure: Anxiety
timeFrame: post-treatment month 1
measure: Anger
timeFrame: post-treatment month 1
measure: Anger
timeFrame: post-treatment month 3
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
References: