Recruiting

RXWell

Sponsor:

University of Pittsburgh

Code:

NCT05658796

Conditions

Mood Disorders

Anxiety

Depressive Symptoms

Depression

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

+RxWell

-RxWell

Study Details

Brief 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, 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

Conditions

Mood Disorders

Anxiety

Depressive Symptoms

Depression

Anxiety Disorders

Study ID

NCT05658796

Start date

Jan 27, 2023

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria for the RXWell Study:

  • 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

Exclusion Criteria for the RXWell Study:

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: Intervention: 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.

no intervention: Control (screen failures)

We will collect data on patient outcomes for patients that did not meet criteria for the RxWell intervention.

Interventions

+RxWell

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.

-RxWell

Treatment as usual

Primary outcome measure

  • Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg) [ Time Frame: POD 1 to Week 4 Post-Op ]

Central Contacts and Locations

Central contacts

Ata Murat Kaynar, MD, MPH

412-383-3463kaynarm@upmc.edu

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

Locations

UPMC East

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Ata Murat Kaynar, MD, MPH

412-383-3463kaynarm@upmc.edu

Amy Monroe, MPH, MBA

4126236382monroeal@upmc.edu

UPMC Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Ata Murat Kaynar, MD, MPH

412-383-3463kaynarm@upmc.edu

Amy Monroe, MPH, MBA

4126236382monroeal@upmc.edu

UPMC Passavant

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Ata Murat Kaynar, MD, MPH

412-383-3463kaynarm@upmc.edu

Amy Monroe, MPH, MBA

4126236382monroeal@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-03.