Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine
Phase: NA
Conditions: Chronic Pain, Pain
Sponsor: Stanford University

 
Virtual Empowered Relief for People With Chronic 
Pain Who Take Methadone or Buprenorphine   
NCT05057988 
2024-04-10 
 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
Pain catastrophizing is a psychological response to pain that serves to make pain worse. 
In order to reduce suffering in people with chronic pain, it is important to treat pain 
catastrophizing. The purpose of the study is to test a single-session pain education class 
for treating pain catastrophizing in people with chronic pain on long-term opioid therapy. 
Class participants learn skills and develop a personalized plan to use the skills every day. 
The study will follow participants for 3 months by administering 5 follow-up surveys at 2 
weeks and 1 month, 2 months, and 3 months post-treatment to determine whether the 
class confers long-term benefits across various aspects of health. 
b. 
Objectives 
The study will provide important information regarding the effectiveness of the pain 
education class and how well it reduces pain catastrophizing in patients on long-term 
opioid therapy for chronic pain. The information learned in this study will allow us to 
determine how reductions in pain catastrophizing may impact related health factors, such 
as pain, sleep, function, depression, and anxiety. 
c. 
Rationale for Research in Humans 
This research necessitates human participants because there is no equivalent animal 
model or non-human model to answer the study questions. The "Virtual Empowered 
Relief" (vER) class is designed for human participants only. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
I. Recruitment: Participants with chronic pain and opioid use disorder will be recruited by 
posting a flyer at methadone or buprenorphine clinics. Potential participants will be 
screened for interest and eligibility via the attached phone script. Participants will be 
informed that participation in the study is optional and not required as part of their care at 
methadone or buprenorphine clinics. They will also be informed that their information 
will not be shared with medical providers and staff at methadone or buprenorphine 

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clinics. During or after this call, all eligible participants will be invited to participate in 
the 2-hour Virtual Empowered Relief (vER) class. 
 
Researchers at RTI International will be involved in recruiting study sites, check-in with 
each study site for posting a flyer, and resolve any recruitment issues at each site-contact. 
However, researchers at RTI will not have a direct contact with patients. Researchers at 
RTI may also analyze de-identified data and write a paper together. 
 
II. Pre-Class Procedures: All interested and eligible participants will receive study 
information and informed consent will be obtained over the phone from each eligible 
participant prior to attending the vER class. Informed consent will be obtained on the 
phone with a research coordinator. All participants will have the informed consent 
presented to them through REDCap, emailed, or mailed to them. 
 
Participants will complete the questionnaire using a secure, HIPAA-compliant, online 
system (via REDCap) or phone. Additionally, the questionnaire may be administered in 
hard copy form. 
 
III. Intervention Pain Education Class "Virtual Empowered Relief" The participants will 
attend the class offered by pain psychologists at Stanford Pain Management Center or the 
Stanford Pain Relief Innovations Lab. This class will be held online via Zoom. The class 
will NOT be recorded. Zoom video function will be disabled so participants will NOT 
see other participants' faces. Participants will also be recommended to display only their 
first name. Class participants will learn skills and develop a personalized plan to use the 
skills every day. At the end of class, participants will be given a survey about the class. 
Treatment participants will receive a relaxation audio file via email or a CD/USB post-
class via mail. We aim to give all patients rapid access to low-risk care that empowers 
them to self-manage their pain and reduce reliance on opioids. If participants cannot 
download the app, they will receive an audio file of the relaxation resource. 
 
IV. Post-Class follow-up: Participants will be followed for approximately 3 months after 
completing the class. Participants will be asked to complete questionnaires at 2 weeks 
and 1, 2, and 3 months after the class. All participants will be provided a link to an online 
secure system (REDCap), paper, or phone to complete follow-up questionnaires. 
 
All questionnaires to be administered by the research staff are attached under section 16 
of the protocol. 
 
Time line for questionnaire administration is as follows: 
 
BEFORE CLASS: 
- Demographics 
- Treatment expectation 
- Medication Use 
- PROMIS clinical questions 
- Non-PROMIS clinical questions 

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IMMEDIATELY AFTER CLASS: 
- Post-class questionnaire 
 
WEEKS 2 and MONTH 1, 2, and 3 POST-CLASS: 
- Medication Use 
- PROMIS clinical questions 
- Non-PROMIS clinical questions 
- Global Impression of Change 
- Treatment change and adverse events 
 
Participants may also be mailed a thank you note. 
b. 
Procedure Risks 
All members of the study team have been trained to conduct the research procedures in 
the safest manner possible. There are no known risks to completing the questionnaires or 
undergoing the vER class. Participants will be informed that they have the right to refuse 
to answer questions and they can withdraw from the study at any time. All the responses 
will not be shared with their medical providers and staff at their methadone or 
buprenorphine clinics. 
c. 
Use of Deception in the Study 
No deception will be used. 
d. 
Use of Audio and Video Recordings 
The class will NOT be recorded. 
e. 
Alternative Procedures or Courses of Treatment 
No standard treatment is being withheld. Participants are encouraged to continue with 
their current course of treatment for their pain under the care of their regular physician. 
Participant's alternative is to not participate. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Participants are free to pursue the treatment of their choice at any time during and/or after 
the study 
g. 
Study Endpoint(s) 
Each participant will meet the study endpoint once he/she completes the last set of 
questionnaires at the final time point. The study will end once the target enrollment is 
reached. 

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3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
At Stanford Pain Management Center, we have routinely delivered the Empowered Relief 
class as pain psychology treatment and have received very high indices of satisfaction 
from class participants. Our previous NIH-funded study on patients with chronic low 
back pain has also shown reductions of pain, pain catastrophizing, and pain interference 
and increase in pain self-efficacy after taking the class. However, we do not know if vER 
is effective in patients with opioid use disorder and chronic pain. The current study will 
allow us to understand whether vER is effective in this patient population who usually 
has a limited access to pain psychology services. Based on the findings from the current 
study, we plan to apply for a NIH funding and do a large scale study. 
 
Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From catastrophizing to 
recovery: a pilot study of a single-session treatment for pain catastrophizing. Journal of 
pain research. 2014;7:219. 
 
Darnall BD, Ziadni MS, Krishnamurthy P, Flood P, Heathcote LC, Mackey IG, Taub CJ, 
Wheeler A. “My surgical success”: effect of a digital behavioral pain medicine 
Intervention on time to opioid cessation after breast cancer surgery—a pilot randomized 
controlled clinical trial. Pain Medicine. 2019 Nov 1;20(11):2228-37. 
 
Darnall et al., Comparison of a Single session Pain Management Skills intervention to a 
Single session Health Education Intervention to Eight sessions of Cognitive Behavioral 
Therapy in Patients with Chronic Low Back Pain: A Randomized Clinical Trial 
(Submitted to JAMA 
open) 
b. 
Findings from Past Animal Experiments 
NA 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
i-iii) A total of up to 100 participants with chronic pain are expected to enroll. 
b. 
Age, Gender, and Ethnic Background 
Men and women, ages 18 and older of any race or ethnicity will be recruited. 
c. 
Vulnerable Populations 
NA 
d. 
Rationale for Exclusion of Certain Populations 
The pain catastrophizing protocols (Taub et al, 2016, Roditi et al, 2009) have been 
validated only for adults with chronic pain. This study will be the first to use this protocol 

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in patients taking opioid pain medications for chronic pain management. If this study 
finds no safety concerns in adult patients with chronic pain and chronic opioid therapy, a 
future study can include children. 
e. 
Stanford Populations 
All participants will be recruited at methadone and buprenorphine clinics in the US. 
Laboratory personnel and employees at Stanford will not be recruited for this study. 
f. 
Healthy Volunteers 
Healthy volunteers are not being recruited for this study 
g. 
Recruitment Details 
We will recruit patients from the methadone or buprenorphine clinics via a flyer (attached). 
Participants with chronic pain and opioid use disorder will be identified by a prescreening survey 
by a research staff at Stanford. We will also recruit patients from the Stanford Pain Clinic using 
the Stanford Pain Registry (https://choir.stanford.edu/). We will partner with the Research 
Participant Engagement Program (RPEP) team for Honest Broker outreach. Potential participants 
are identified via STARR and invited by RPEP team (honest broker) on behalf of study team. See 
Section 16 for Honest Broker study invitation letters. We will be using Postal Mail Honest Broker 
outreach. For Postal Mail, study team may support the process by sticking pre-printed address 
labels (created by RPEP, the honest broker) on the envelopes. 
 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
1)Age 18+ 
2)Chronic pain at least 3 month 
3)Taking Methadone or buprenorphine 
ii. 
Exclusion Criteria 
1) Cognitive impairment 
2) Pregnant 
3) non-English speaking. 
i. 
Screening Procedures 
Contact information of potential participants will be collected from the Stanford Pain 
Clinic or via REDCap survey linked to the study website. Potential participants will be 
screened using the attached phone script (section 13) to determine eligibility prior to 
consent. We are obtaining a limited waiver of authorization to collect eligibility 
information in the phone screen as well as to access the patient's Medical Record and 
Clinic Registry (clinical questionnaire database) to assess eligibility. 

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j. 
Participation in Multiple Protocols 
Participants will be asked whether they are enrolled in any other research studies. If 
another study's procedures interferes with our own or places the subject at increased risk, 
he/she will not be enrolled in our study. 
k. 
Payments to Participants 
Participants will be compensated with Amazon gift card for completing assessments at 
prescreening ($10), baseline and post-intervention ($20 & $25), 2-week ($20), 1-month 
($30), 2-month ($20), and 3-month ($20) after the class ($145 total). Participants will be 
compensated with $20 gift card for completion of optional lifetime OUD survey. 
l. 
Costs to Participants 
No costs will be charged to the participant. 
m. 
Planned Duration of the Study 
We estimate the study to take less than 1 year to complete. 
i)1-3 months for recruitment and screening of participants 
ii)approximately 3 months of active participation, including 2.5 hours for the class, 15-20 
minutes for completing each round of questionnaires, and a 15-30 minutes post class 
phone call by a Stanford Research Coordinator. 
iii)3 months of analysis. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
NA 
ii. 
Investigational drugs 
NA 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
NA 
iv. 
Procedures 
NA. 
 
v. 
Radioisotopes/radiation-producing machines 
NA 
vi. 
Physical well-being 
NA 

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vii. 
Psychological well-being 
viii. 
Economic well-being 
NA 
ix. 
Social well-being 
There is the risk that PHI will be accidentally be disclosed to people outside of the study 
staff. 
x. 
Overall evaluation of risk 
Minimum 
b. 
International Research Risk Procedures 
NA 
c. 
Procedures to Minimize Risk 
Risks of discomfort due to the questionnaires will be minimized by allowing the 
participant to refuse to answer particular questions. 
 
All participant information will be stored in a locked cabinet and on an encrypted, 
password-protected computer. 
 
Patients exhibiting signs of depression may be encouraged to speak to their medical 
providers at methadone or buprenorphine clinic. 
d. 
Study Conclusion 
The experiment will terminate when all participants have completed participation. If an 
individual participant chooses to withdraw, or the researcher determines it is unsafe or 
scientifically invalid for him/her to continue, his/her participation will end. We do not 
anticipate the study will directly result in adverse effects to the participants. However, we 
will encourage them to speak to their medical provider at methadone or buprenorphine 
clinic for any necessary medical intervention in the event of an adverse event. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
Self-reported adverse events were collected at each data point (monthly) for 3 months 
(the study endpoint). Adverse events were reviewed as soon as participants reported 
any events on the REDCap, which sent automatic email notification to Dr. You, PI.  
ii. 
Person(s) responsible for Data and Safety Monitoring 
Dokyoung Sophia You, PhD 
iii. 
Frequency of DSMB meetings 
N/A 

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iv. 
Specific triggers or stopping rules 
Any SAEs that are probably or possibly related to this study 
v. 
DSMB Reporting 
No DSMB 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Y 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
N 
f. 
Risks to Special Populations 
NA 
6. 
BENEFITS 
Participants may or may not experience benefits from the "Virtual Empowered Relief" (vER) 
class. The vER class is designed to help patients learn new skills to better cope with chronic 
pain. Knowledge gained from this study may inform future research studies and clinical 
treatments aimed at reducing catastrophizing in patients with opioid use disorder and chronic 
pain. Furthermore, the patient may also benefit from lowering opioid dose. 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.