An interventional study of +RxWell and -RxWell in Mood Disorders, Anxiety and Depressive Symptoms, sponsored by University of Pittsburgh. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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
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:
reduce resources utilization such as hospital length of stay, postoperative need for visits and the use of rehabilitation.
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria for the RXWell Study:
A PROMIS Anxiety and/or Depression T-score >70, which corresponds to severe anxiety and depression.
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
Behavioral: -RxWell
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.
Behavioral: +RxWell
We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.
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.
Treatment as usual
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).
Time frame: POD 1 to Week 4 Post-Op
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Op 1 Month, Post-Op 3 Months
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.
Of 151 non-industry interventional studies with no phase under Mood Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 46 months is above that.
Counting every sponsor, half of 162 studies reached it within 21 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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