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

Primary Purpose

Chronic Pain, Marfan Syndrome, Vascular Ehlers-Danlos Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Empowered Relief
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Empowered Relief

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of participants registered for class
    Full registration for the online session (N=100)
    Class attendance
    60% attendance rate (N=60)
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 5, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05980104
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 12, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain, Marfan Syndrome, Vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Empowered Relief
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Empowered Relief
    Intervention Description
    A certified instructor delivers 1 online session of a pain relief skills intervention (Empowered Relief) to one group of patients
    Primary Outcome Measure Information:
    Title
    Number of participants registered for class
    Description
    Full registration for the online session (N=100)
    Time Frame
    baseline
    Title
    Class attendance
    Description
    60% attendance rate (N=60)
    Time Frame
    at treatment
    Title
    Treatment appraisal
    Description
    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.
    Time Frame
    immediately post-treatment
    Secondary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Pain Catastrophizing
    Description
    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.
    Time Frame
    post-treatment month 3
    Other Pre-specified Outcome Measures:
    Title
    Pain Intensity
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Pain Catastrophizing
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Pain Interference
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Pain Interference
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Sleep Disturbance
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Sleep Disturbance
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Pain Bothersomeness
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Pain Bothersomeness
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Fatigue
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Fatigue
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Satisfaction with Participation in Social Roles
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Satisfaction with Participation in Social Roles
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Pain Self-Efficacy Questionnaire
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Pain Self-Efficacy Questionnaire
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Depression
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Depression
    Description
    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.
    Time Frame
    post-treatment month 1
    Title
    Anxiety
    Description
    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.
    Time Frame
    post-treatment month 3
    Title
    Anxiety
    Description
    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.
    Time Frame
    post-treatment month 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Beth Darnall, PhD
    Phone
    650-723-2040
    Email
    bdarnall@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Corinne Jung, PhD
    Phone
    650-724-0522
    Email
    cejung@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beth Darnall, PhD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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