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Completed

NCT Number: NCT05980104

Single-Session "Empowered Relief" Class for 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.

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Key information

Conditions

Chronic Pain Abnormalities, Multiple Aneurysm Aortic Aneurysm Aortic Diseases Aortic Dissection Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Dissection, Blood Vessel Ehlers-Danlos Syndrome Ehlers-Danlos Syndrome, Type IV Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Loeys-Dietz Syndrome Marfan Syndrome Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases Vascular Ehlers-Danlos Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empowered Relief

Behavioral

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

Primary outcomes

  1. Number of participants registered for class

    Time frame: baseline

    Full registration for the online session (N=100)

  2. Class Attendance

    Time frame: at treatment

    At least 70% attendance for the registered Empowered Relief online class

  3. Treatment appraisal

    Time frame: immediately post-treatment

    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.

Secondary outcomes

  1. Pain Intensity

    Time frame: post-treatment month 3

    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.

  2. Pain Catastrophizing

    Time frame: post-treatment month 3

    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.

Other outcomes

  1. Pain Intensity

    Time frame: post-treatment month 1

    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.

  2. Pain Catastrophizing

    Time frame: post-treatment month 1

    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.

  3. Pain Interference

    Time frame: post-treatment month 3

    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.

  4. Pain Interference

    Time frame: post-treatment month 1

    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.

  5. Sleep Disturbance

    Time frame: post-treatment month 3

    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.

  6. Sleep Disturbance

    Time frame: post-treatment month 1

    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.

  7. Pain Bothersomeness

    Time frame: post-treatment month 3

    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.

  8. Pain Bothersomeness

    Time frame: post-treatment month 1

    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.

  9. Fatigue

    Time frame: post-treatment month 3

    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.

  10. Fatigue

    Time frame: post-treatment month 1

    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.

  11. Satisfaction with Participation in Social Roles

    Time frame: post-treatment month 3

    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.

  12. Satisfaction with Participation in Social Roles

    Time frame: post-treatment month 1

    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.

  13. Pain Self-Efficacy Questionnaire

    Time frame: post-treatment month 3

    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.

  14. Pain Self-Efficacy Questionnaire

    Time frame: post-treatment month 1

    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.

  15. Depression

    Time frame: post-treatment month 3

    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.

  16. Depression

    Time frame: post-treatment month 1

    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.

  17. Anxiety

    Time frame: post-treatment month 3

    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.

  18. Anxiety

    Time frame: post-treatment month 1

    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.

  19. Anger

    Time frame: post-treatment month 1

    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.

  20. Anger

    Time frame: post-treatment month 3

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • The Marfan Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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