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RxWell for Mood Disorders (RxWell Trial)

N/A

Waitlist Available

Led By Jacques Chelly, MD, PhD, MBA

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op 1 month, post-op 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve peri-operative care, hasten recovery, and save resources for UPMC ISD by using a platform called RxWell.

Who is the study for?

This trial is for individuals scheduled for elective orthopedic surgery at select UPMC hospitals, who are experiencing high levels of anxiety or depression as measured by specific tests. Participants must have access to a smartphone or tablet and not require immediate intervention for severe mood disorders.

What is being tested?

The SuRxgWell study is testing the RxWell platform's effectiveness in managing mood disorders like anxiety and depression to improve recovery outcomes after surgery. The trial will compare patients using RxWell with those not using it.

What are the potential side effects?

Since this trial involves a digital platform for mood management rather than medication, traditional side effects are not expected. However, users may experience discomfort if they find the technology challenging or if it triggers emotional responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-op 1 month, post-op 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-op 1 month, post-op 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op 1 month, post-op 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative Opioid Consumption in Oral Morphine Equivalent (OME) (mg)

Secondary study objectives

Opioid prescription refills by 3 months

Pain at Rest

Pain with Movement

+1 more

Other study objectives

Surgical outcomes: rate of readmission

Surgical outcomes: same day discharge

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intervention: RxWellExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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

Group III: Control (screen failures)Active Control1 Intervention

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

Do I qualify?Apply below to find out