Mood DisordersRxWellNCT05658796
RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
A study testing +RxWell and -RxWell in people with Mood Disorders and Anxiety, run by University of Pittsburgh at 3 sites in United States.
Trial summary
It is envisioned that multipronged benefits from this pilot work for the UPMC ISD and its members. It is expected the RxWell platform to provide the following benefits: expansion of the use of RxWell to all UPMC ISD members providing peri-operative mood management with advantage of improved peri-operative outcomes… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mood Disorders, Anxiety, Depressive Symptoms
- What is being tested?
- +RxWell and -RxWell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2023to 30 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years
- Scheduled for elective primary total knee arthroplasty (TKA) or hip replacement (THA) at the approved UPMC hospitals
- Moderately high levels of mood disorder symptoms on validated PROMIS measures, defined as a T-score > or = to 60 on PROMIS Anxiety 4a short form and/or PROMIS Depression4a short form
Who cannot join
- Patients undergoing non-elective surgery or secondary arthroplasty
- Active delirium, neurocognitive impairment, or severe intellectual disability
- No access to a smart device (phone or tablet)
- Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
- Profound mood disorders requiring immediate intervention such as suicidal ideation, defined as a PROMIS Depression score of more than 70
- A PROMIS Anxiety and/or Depression T-score >70, which corresponds to severe anxiety and depression.
- Patients needing immediate care will be referred to psychiatrists and primary team.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UPMC East
Monroeville, Pennsylvania, 15146
Ata Murat Kaynar, MD, MPH, 412-383-3463, kaynarm@upmc.edu
Amy Monroe, MPH, MBA, 4126236382, monroeal@upmc.edu
- Recruiting
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
Ata Murat Kaynar, MD, MPH, 412-383-3463, kaynarm@upmc.edu
Amy Monroe, MPH, MBA, 4126236382, monroeal@upmc.edu
- Recruiting
UPMC Passavant
Pittsburgh, Pennsylvania, 15237
Ata Murat Kaynar, MD, MPH, 412-383-3463, kaynarm@upmc.edu
Amy Monroe, MPH, MBA, 4126236382, monroeal@upmc.edu
About this study
Official title: Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty
It is envisioned that multipronged benefits from this pilot work for the UPMC ISD and its members. It is expected the RxWell platform to provide the following benefits: expansion of the use of RxWell to all UPMC ISD members providing peri-operative mood management with advantage of improved peri-operative outcomes, improving saving for the UPMC ISD by hastening the recovery and decreased resource utilization, and addition to the high-value care of UPMC with this holistic approach to patient perioperative care
Read the detailed description
The content of the digital behavioral tool was developed based on standard Cognitive Behavioral Therapy (CBT) techniques. An additional layer of support includes a behavioral health coach who provides guidance and motivation throughout the use of the app via in-app text messaging.
This approach has already been tested at UPMC on multiple adult clinical populations. This project represents the first pilot of the digital behavioral tool with perioperative patients
The digital behavioral tool can provide a resource gap by providing preventive mental health services to promote mental health wellness for patients to help reduce the deleterious impact of established mood disorders on recovery following primary total knee replacements including:
- pain and opioid requirement,
- functional recovery,
- decrease complications, and
- reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.
- Determine the feasibility of using RxWell for patients undergoing elective surgery who have mood disorder symptoms using MyUPMC platform and established either at the time of visiting the Center for Perioperative Care (CPC) either in-person or via anesthesia telemedicine services (ATS) in a tertiary care system.
- Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.
Subjects who choose to sign electronically will be provided a link via email for REDCap. This link will include an electronic consent document and the ability to sign with a computer cursor, stylus, or their finger depending on the device the subject uses to access this link.
- Conditions
- Mood Disorders, Anxiety, Depressive Symptoms, Depression, Anxiety Disorders, Anxiety Depression
- Being tested
- +RxWell, -RxWell
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+RxWellBehavioural
During the SuRxgWell trial, if a participant is randomized to receive RxWell, they will be provided with an access code that is required to download the app. Once the participant has downloaded the app, they will be paired with a UPMC coach who will guide the person through the sessions using in-app texting to help give them the tools needed to actively cope with anxiety and/or depression. The UPMC coaches are supervised by a licensed UPMC mental health clinician. The participant will have access to the app and coach for six months after they have consented. The digital behavioral tool includes over 30 brief Cognitive Behavioral Therapy (CBT) and mindfulness-based techniques. Subjects enrolled after 01DEC25 were unable to download the RxWell application because it was removed from the app store. To avoid disruption, direct access to the RxWell application was replaced with a 30-minute, directed, telemedicine, health coaching session, on at least 2 occasions prior to surgery.
-RxWellBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | No intervention (No RxWell). Subjects will receive standard of care and education regarding potential resources for anxiety and depression. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes Receives: Behavioral: -RxWell |
| Intervention: RxWell | Experimental | RxWell Intervention. Subjects will receive standard of care and digital cognitive behavioral intervention by using the application RxWell. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes and will complete GAD-7 (Generalized Anxiety Disorder Scale) and PHQ-8 (Patient Health Questionnaire for Depression) every 2 weeks within the RxWell application. Receives: Behavioral: +RxWell |
| Control (screen failures) | No intervention | We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
This outcome will be measured by extracting pain medication data from the electronic health record to determine OME (oral morphine equivalents) (mg) for opioid medications on POD 1 and 2, and weeks 1 and 4 following surgery. This will be recorded for each study arm as mean (SD).
Measured: POD 1 to Week 4 Post-Op
Secondary outcomes (4)
Opioid prescription refills by 3 months
This outcome will be measured by abstracting the PDMP review from the medical records to determine the number of opioid prescription refills by post-op month 3. This will be counted per patient and each arm will be recorded as a mean (SD).
Measured: Post-Op Month 3
Pain at Rest
Pain scores will be collected using a numerical rating scale (NRS) in which 0 = no pain at all, and 10 = worst pain imaginable. This outcome will be averaged in each arm and reported as mean (SD) for each timepoint provided in the time frame.
Measured: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Pain with Movement
Pain scores will be collected using a numerical rating scale (NRS) in which 0 = no pain at all, and 10 = worst pain imaginable. This outcome will be averaged in each arm and reported as mean (SD) for each timepoint provided in the time frame.
Measured: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Persistent Opioid Use
This outcome will be measured by the number of participants still using opioids at the timepoints provided in the time frame. This is a binary yes/no response - yes, the subject is using opioids, no the subject is not using opioids and will be abstracted from the medical records.
Measured: Post-Op 1 Month, Post-Op 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start27 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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 Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ata Murat Kaynar, University of Pittsburgh
- Investigators
- Ata Murat Kaynar, MD, MPH, Principal investigator, UPMC Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658796
- Sponsor's protocol ID
- STUDY21120053
- Other IDs
- R21DA061414-01
- Acronym
- RxWell
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaynar AM, Lin C, Sanchez AG, Lavage DR, Monroe A, Zharichenko N, Strassburger M, Saucier K, Groff YJ, Klatt BA, O'Malley MJ, Szigethy E, Wasan AD, Chelly JE. SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery. Trials. 2023 Nov 9;24(1):715. doi: 10.1186/s13063-023-07634-0.
PubMed 37946291
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05658796
- Acronym / sponsor ID
- RxWell / STUDY21120053
- Conditions
- Mood Disorders, Anxiety, Depressive Symptoms, Depression, Anxiety Disorders, Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Dec 2022 (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.
It is envisioned that multipronged benefits from this pilot work for the UPMC ISD and its members. It is expected the RxWell platform to provide the following benefits: expansion of the use of RxWell to all UPMC ISD members providing peri-operative mood management with advantage of improved peri-operative outcomes, improving saving for the UPMC ISD by hastening the recovery and decreased resource utilization, and addition to the high-value care of UPMC with this holistic approach to patient perioperative care
Detailed description
The content of the digital behavioral tool was developed based on standard Cognitive Behavioral Therapy (CBT) techniques. An additional layer of support includes a behavioral health coach who provides guidance and motivation throughout the use of the app via in-app text messaging.
This approach has already been tested at UPMC on multiple adult clinical populations. This project represents the first pilot of the digital behavioral tool with perioperative patients
The digital behavioral tool can provide a resource gap by providing preventive mental health services to promote mental health wellness for patients to help reduce the deleterious impact of established mood disorders on recovery following primary total knee replacements including:
- pain and opioid requirement,
- functional recovery,
- decrease complications, and
- reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.
- Determine the feasibility of using RxWell for patients undergoing elective surgery who have mood disorder symptoms using MyUPMC platform and established either at the time of visiting the Center for Perioperative Care (CPC) either in-person or via anesthesia telemedicine services (ATS) in a tertiary care system.
- Determine the impact of RxWell-associated improvements in anxiety, depression, and catastrophizing on postoperative outcomes with a special focus on resources utilization.
Subjects who choose to sign electronically will be provided a link via email for REDCap. This link will include an electronic consent document and the ability to sign with a computer cursor, stylus, or their finger depending on the device the subject uses to access this link.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: -RxWellNo intervention (No RxWell). Subjects will receive standard of care and education regarding potential resources for anxiety and depression. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes |
| Intervention: RxWell | Experimental | Behavioral: +RxWellRxWell Intervention. Subjects will receive standard of care and digital cognitive behavioral intervention by using the application RxWell. Subjects will complete questionnaires via REDCap assessing primary and secondary outcomes and will complete GAD-7 (Generalized Anxiety Disorder Scale) and PHQ-8 (Patient Health Questionnaire for Depression) every 2 weeks within the RxWell application. |
| Control (screen failures) | No intervention | –We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years
- Scheduled for elective primary total knee arthroplasty (TKA) or hip replacement (THA) at the approved UPMC hospitals
- Moderately high levels of mood disorder symptoms on validated PROMIS measures, defined as a T-score > or = to 60 on PROMIS Anxiety 4a short form and/or PROMIS Depression4a short form
Key exclusion criteria (7 listed)
- Patients undergoing non-elective surgery or secondary arthroplasty
- Active delirium, neurocognitive impairment, or severe intellectual disability
- No access to a smart device (phone or tablet)
- Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
- Profound mood disorders requiring immediate intervention such as suicidal ideation, defined as a PROMIS Depression score of more than 70
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 |
|---|---|---|
| +RxWellDuring the SuRxgWell trial, if a participant is randomized to receive RxWell, they will be provided with an access code that is required to download the app. Once the participant has downloaded the app, they will be paired with a UPMC coach who will guide the person through the sessions using in-app texting to help give them the tools needed to actively cope with anxiety and/or depression. The UPMC coaches are supervised by a licensed UPMC mental health clinician. The participant will have access to the app and coach for six months after they have consented. The digital behavioral tool includes over 30 brief Cognitive Behavioral Therapy (CBT) and mindfulness-based techniques. Subjects enrolled after 01DEC25 were unable to download the RxWell application because it was removed from the app store. To avoid disruption, direct access to the RxWell application was replaced with a 30-minute, directed, telemedicine, health coaching session, on at least 2 occasions prior to surgery. | Behavioural | Intervention: RxWell |
| -RxWellTreatment as usual | Behavioural | Control |
Primary outcome
Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)
Time frame: POD 1 to Week 4 Post-Op
This outcome will be measured by extracting pain medication data from the electronic health record to determine OME (oral morphine equivalents) (mg) for opioid medications on POD 1 and 2, and weeks 1 and 4 following surgery. This will be recorded for each study arm as mean (SD).
4 secondary outcomes
Opioid prescription refills by 3 months
Time frame: Post-Op Month 3
Pain at Rest
Time frame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Pain with Movement
Time frame: Post-Op Day 1, Post-Op Day 2, and Post-Op Day 7
Persistent Opioid Use
Time frame: Post-Op 1 Month, Post-Op 3 Months
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 3 Jun 2026.
- Derived from this study: PubMed 37946291Kaynar AM, Lin C, Sanchez AG, Lavage DR, Monroe A, Zharichenko N, Strassburger M, Saucier K, Groff YJ, Klatt BA, O'Malley MJ, Szigethy E, Wasan AD, Chelly JE. SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery. Trials. 2023 Nov 9;24(1):715. doi: 10.1186/s13063-023-07634-0.
- 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.
Ata Murat Kaynar, MD, MPH principal investigator
UPMC Department of Anesthesiology and Perioperative Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing +RxWell and -RxWell in people with Mood Disorders and Anxiety, run by University of Pittsburgh at 3 sites 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 3 inclusion and 7 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Ata Murat Kaynar, MD, MPH (412-383-3463, kaynarm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg) (time frame: POD 1 to Week 4 Post-Op). 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 NCT05658796, 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 3 Jun 2026.