Chronic PainNCT04546685
Virtual 1-Session Spanish "Empowered Relief" Group Intervention for Chronic Pain
A study testing Empowered Relief in people with Chronic Pain, 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
- 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
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18+
- Chronic pain (at least 3 months or more)
- Spanish fluency
- Ability to adhere to and complete study procedures
Who cannot join
- Cognitive impairment
- Previous participation in the Empowered Relief class
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Corrine A Jung, PhD contact
United States1 site, 1 recruiting
- Recruiting
1070 Arastradero Rd
Palo Alto, California, 94304-1334
Lorena Contreras, spanishempoweredrelief@stanford.edu
Beth Darnall, PhD
About this study
Official title: Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
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 randomized trial is to conduct the first feasibility and early efficacy test of online Spanish ER delivered to Spanish-speaking adult patients with chronic pain. Participants will be followed for 1 month via 3 follow-up surveys (immediately after treatment, 2 weeks and 1 month post-treatment).
Read the detailed description
Poor access to behavioral pain care contributes substantially to chronic pain burden, particularly for underserved populations such as non-English speaking patients. Empowered Relief (ER) is an evidence-based 1-session (two hour) intervention that rapidly equips individuals with effective pain relief skills. Published evidence from four randomized trials suggest benefits in pain and symptom reduction up to 6 months later. While Spanish ER is being delivered by certified instructors in the U.S., Chile, Spain, Mexico and Puerto Rico, no study has examined patient perceptions and early treatment outcomes for Spanish ER. The investigators will conduct a randomized feasibility and short-term efficacy trial in 110 Spanish speaking patients with chronic pain. The investigators will compare online Spanish Empowered Relief® (ER) vs. Usual Care (UC) in patients with chronic pain of any type (>= 3 months). Participants will be 1:1 randomized to either ER or UC. The study primary endpoint is change in pain intensity or pain interference from baseline to 1 month follow-up (short-term efficacy). UC will be invited to cross over to ER after their 1-month survey (treatment appraisal and satisfaction data only will be collected after receipt of ER).
Aim 1: Test the feasibility of online group-based Spanish 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): Compare ER vs. UC for reducing multi-primary outcomes (pain intensity or pain interference) and secondary outcomes at 1 month post-treatment.
Hypothesis 2a: Outcome 3, ER will be superior to UC for reducing pain intensity or pain interference from baseline to 1 month follow-up (multi-primary study endpoint).
Hypothesis 2b: Outcome 4, ER will be superior to UC for reducing 4 priority secondary outcomes (sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety) from baseline to 1 month follow-up.
Hypothesis 2c: Outcome 5, ER will be superior to UC for reducing other secondary outcomes (satisfaction with social roles and responsibilities, anger, fatigue, pain self-efficacy, and depression) from baseline to 1 month follow-up. Patient outcomes will be longitudinally tracked at week 2 and 1 month after the intervention session for ER participants, and at week 2 and 1 month for the UC group.
- Conditions
- Chronic Pain
- Being tested
- Usual Care, Empowered Relief
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Also called Waitlist
Participants who are randomized to the Usual Care group (waitlist for cross-over to ER) will be instructed to continue with their normal pain care. They will receive only study surveys (baseline, 2 weeks, and 1 month). Upon completion of the 1-month study, UC participants will be invited to cross-over and receive ER. Post-class treatment appraisal/satisfaction data only will be collected.
Empowered ReliefBehavioural
Also called 1-Session Pain Relief Skills Intervention
The participants will attend an online Spanish Empowered Relief class. 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 Spanish binaural relaxation audio file for daily use.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (waitlist) | Other | Participants will continue their usual clinical care. Receives: Other: Usual Care |
| 1-Session pain relief skills class (online Spanish 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 Spanish-fluent 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.
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
Class Attendance
At least 70% attendance for the registered Empowered Relief online class cohorts.
Measured: At treatment
Secondary outcomes (11)
Pain intensity
Pain intensity: within-subject baseline to 1 month using the Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity 1-item scale assesses 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 1-month
Pain interference
Pain interference: within-subject baseline to 1 month using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 8-item scale assesses 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.
Measured: Post-treatment 1-month
Sleep disturbance
Sleep disturbance: Within-subject baseline to 1 month using the Patient-reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 6-item scale assesses sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.
Measured: Post-treatment 1-month
Pain catastrophizing
Pain Catastrophizing: Within-subject baseline to 1 month, the Pain Catastrophizing 13-item scale quantifies an individual's pain experience. Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Measured: Post-treatment 1-month
Pain bothersomeness
Pain bothersomeness: Within-subject baseline to 1 month the Pain Bothersomeness 1-item scale rated 0-10 assesses pain bothersomeness over the past 7 days. Higher scores represent a greater degree of pain bothersomeness.
Measured: Post-treatment 1-month
Anxiety
Anxiety: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 6-item scale assesses 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.
Measured: Post-treatment 1-month
Satisfaction with participation in social roles
Satisfaction with participation in social roles: Within-subject baseline to 1 month the PROMIS Satisfaction with Participation in Social Roles 7-item scale assesses 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.
Measured: Post-treatment 1-month
Anger
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.
Measured: Post-treatment 1-month
Fatigue
Fatigue: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 8-item scale assesses 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.
Measured: Post-treatment 1-month
Depression
Depression: Within-subject baseline to 1 month with the Patient Reported Outcomes Measurement Information System (PROMIS) Depression 6-item scale assesses negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.
Measured: Post-treatment 1-month
Pain Self-Efficacy
Pain Self-Efficacy: Within-subject baseline to 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.
Measured: Post-treatment 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start12 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- SCAN Health Plan, The Cleveland Clinic
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
- Investigators
- Beth Darnall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546685
- Sponsor's protocol ID
- 74942
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziadni MS, Gonzalez-Castro L, Anderson S, Krishnamurthy P, Darnall BD. Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. J Med Internet Res. 2021 Sep 10;23(9):e29672. doi: 10.2196/29672.
PubMed 34505832Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
PubMed 34022930
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
- ClinicalTrials.gov ID
- NCT04546685
- Acronym / sponsor ID
- 74942
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- SCAN Health Plan, The Cleveland Clinic
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2020 (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 randomized trial is to conduct the first feasibility and early efficacy test of online Spanish ER delivered to Spanish-speaking adult patients with chronic pain. Participants will be followed for 1 month via 3 follow-up surveys (immediately after treatment, 2 weeks and 1 month post-treatment).
Detailed description
Poor access to behavioral pain care contributes substantially to chronic pain burden, particularly for underserved populations such as non-English speaking patients. Empowered Relief (ER) is an evidence-based 1-session (two hour) intervention that rapidly equips individuals with effective pain relief skills. Published evidence from four randomized trials suggest benefits in pain and symptom reduction up to 6 months later. While Spanish ER is being delivered by certified instructors in the U.S., Chile, Spain, Mexico and Puerto Rico, no study has examined patient perceptions and early treatment outcomes for Spanish ER. The investigators will conduct a randomized feasibility and short-term efficacy trial in 110 Spanish speaking patients with chronic pain. The investigators will compare online Spanish Empowered Relief® (ER) vs. Usual Care (UC) in patients with chronic pain of any type (>= 3 months). Participants will be 1:1 randomized to either ER or UC. The study primary endpoint is change in pain intensity or pain interference from baseline to 1 month follow-up (short-term efficacy). UC will be invited to cross over to ER after their 1-month survey (treatment appraisal and satisfaction data only will be collected after receipt of ER).
Aim 1: Test the feasibility of online group-based Spanish 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): Compare ER vs. UC for reducing multi-primary outcomes (pain intensity or pain interference) and secondary outcomes at 1 month post-treatment.
Hypothesis 2a: Outcome 3, ER will be superior to UC for reducing pain intensity or pain interference from baseline to 1 month follow-up (multi-primary study endpoint).
Hypothesis 2b: Outcome 4, ER will be superior to UC for reducing 4 priority secondary outcomes (sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety) from baseline to 1 month follow-up.
Hypothesis 2c: Outcome 5, ER will be superior to UC for reducing other secondary outcomes (satisfaction with social roles and responsibilities, anger, fatigue, pain self-efficacy, and depression) from baseline to 1 month follow-up. Patient outcomes will be longitudinally tracked at week 2 and 1 month after the intervention session for ER participants, and at week 2 and 1 month for the UC group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (waitlist) | Other | Other: Usual CareParticipants will continue their usual clinical care. |
| 1-Session pain relief skills class (online Spanish 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 Spanish-fluent 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)
- Age 18+
- Chronic pain (at least 3 months or more)
- Spanish fluency
- Ability to adhere to and complete study procedures
Key exclusion criteria (2 listed)
- Cognitive impairment
- Previous participation in the Empowered Relief class
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 |
|---|---|---|
| Usual CareAlso: WaitlistParticipants who are randomized to the Usual Care group (waitlist for cross-over to ER) will be instructed to continue with their normal pain care. They will receive only study surveys (baseline, 2 weeks, and 1 month). Upon completion of the 1-month study, UC participants will be invited to cross-over and receive ER. Post-class treatment appraisal/satisfaction data only will be collected. | Other | Usual Care (waitlist) |
| Empowered ReliefAlso: 1-Session Pain Relief Skills InterventionThe participants will attend an online Spanish Empowered Relief class. 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 Spanish binaural relaxation audio file for daily use. | Behavioural | 1-Session pain relief skills class (online Spanish Empowered Relief) |
Primary outcome
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.
Class Attendance
Time frame: At treatment
At least 70% attendance for the registered Empowered Relief online class cohorts.
11 secondary outcomes
Pain intensity
Time frame: Post-treatment 1-month
Pain interference
Time frame: Post-treatment 1-month
Sleep disturbance
Time frame: Post-treatment 1-month
Pain catastrophizing
Time frame: Post-treatment 1-month
Pain bothersomeness
Time frame: Post-treatment 1-month
Anxiety
Time frame: Post-treatment 1-month
Satisfaction with participation in social roles
Time frame: Post-treatment 1-month
Anger
Time frame: Post-treatment 1-month
Fatigue
Time frame: Post-treatment 1-month
Depression
Time frame: Post-treatment 1-month
Pain Self-Efficacy
Time frame: Post-treatment 1-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 34505832Ziadni MS, Gonzalez-Castro L, Anderson S, Krishnamurthy P, Darnall BD. Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. J Med Internet Res. 2021 Sep 10;23(9):e29672. doi: 10.2196/29672.
- Derived from this study: PubMed 34022930Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
Corrine A Jung, PhD contact
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, 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 2 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorena Contreras (650-497-6141, spanishempoweredrelief@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment appraisal (time frame: Immediately post-treatment). The study lists 2 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 NCT04546685, which also lists 2 linked publications.
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 22 Dec 2025.