Chronic PainNCT05980104
Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions
A study testing Empowered Relief in people with Chronic Pain and Marfan Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Marfan Syndrome, Vascular Ehlers-Danlos Syndrome
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Empowered Relief
- Medical subject headings
- Chronic Pain, Marfan Syndrome, Ehlers-Danlos Syndrome, Type IV, Loeys-Dietz Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
Also called 1-Session Pain Relief Skills Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 1-Session pain relief skills class (online Empowered Relief) | Experimental | 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. Receives: Behavioral: Empowered Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants registered for class
Full registration for the online session (N=100)
Measured: baseline
Class Attendance
At least 70% attendance for the registered Empowered Relief online class
Measured: 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.
Measured: immediately post-treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: post-treatment month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start21 Mar 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Marfan Foundation
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
- Investigators
- Beth Darnall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980104
- Sponsor's protocol ID
- 68906
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez L, Palenski P, Monson EA, Contreras L, Dorsonne B, Hailu AY, Gedeon K, Boyd H, Ziadni M, Herrick A, Friedman A, Xu J, Hong J, Tian L, Darnall BD. Online 1-session Empowered Relief in Marfan syndrome and related diseases: a single-arm feasibility and pilot efficacy study. Sci Rep. 2026 Jan 6;16(1):499. doi: 10.1038/s41598-025-29943-x.
PubMed 41495090
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Single-Session "Empowered Relief" Class for Individuals with Marfan Syndrome and Related Conditions
- ClinicalTrials.gov ID
- NCT05980104
- Acronym / sponsor ID
- 68906
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Marfan Foundation
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-Session pain relief skills class (online Empowered Relief) | Experimental | Behavioral: Empowered ReliefEmpowered 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefAlso: 1-Session Pain Relief Skills InterventionThe 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. | Behavioural | 1-Session pain relief skills class (online Empowered Relief) |
Primary outcome
Number of participants registered for class
Time frame: baseline
Full registration for the online session (N=100)
Class Attendance
Time frame: at treatment
At least 70% attendance for the registered Empowered Relief online class
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.
2 secondary outcomes
Pain Intensity
Time frame: post-treatment month 3
Pain Catastrophizing
Time frame: post-treatment month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 41495090Perez L, Palenski P, Monson EA, Contreras L, Dorsonne B, Hailu AY, Gedeon K, Boyd H, Ziadni M, Herrick A, Friedman A, Xu J, Hong J, Tian L, Darnall BD. Online 1-session Empowered Relief in Marfan syndrome and related diseases: a single-arm feasibility and pilot efficacy study. Sci Rep. 2026 Jan 6;16(1):499. doi: 10.1038/s41598-025-29943-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Darnall, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief in people with Chronic Pain and Marfan Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants registered for class (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.