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RxWell for Mood Disorders (RxWell Trial)
N/A
Recruiting
Led By Murat Kaynar
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 pre-op to 3 months post-op
Awards & highlights
RxWell Trial 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.Check my eligibility
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.See study design
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.
RxWell Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-op to 3 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op to 3 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of RxWell on depression in the immediate pre- and post-operative periods: PHQ-8 (Patient Health Questionnaire-8 Depression Scale). The minimum score is 0 and the maximum score is 24. A higher score correlates with higher levels of depression.
Impact of RxWell on depression in the immediate pre- and post-operative periods: PROMIS scale
Impact of RxWell on general anxiety disorder in the immediate pre- and post-operative periods: GAD-7
+3 moreSecondary outcome measures
Ability to participate in social roles
Cognitive function
Fatigue
+13 moreOther outcome measures
Surgical outcomes: rate of readmission
Surgical outcomes: same day discharge
RxWell 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.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,720 Previous Clinical Trials
16,342,755 Total Patients Enrolled
7 Trials studying Mood Disorders
750 Patients Enrolled for Mood Disorders
Murat KaynarPrincipal InvestigatorUPMC Department of Anesthesiology and Perioperative Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing severe mood swings or thoughts of harming myself that need immediate attention.I have a severe intellectual disability.I am scheduled for elective orthopedic surgery at a specified UPMC hospital.I am having surgery that wasn't planned or a repeat joint replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention: RxWell
- Group 3: Control (screen failures)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees still joining this research endeavor?
"The clinicaltrial.gov website reveals that this medical trial is not presently recruiting candidates. Initially posted on December 1st 2022 and last updated on the 16th of the same month, it appears to be inactive for now; however, there are 2,432 other trials searching for patients at present."
Answered by AI
What are the core aims of this experiment?
"The primary purpose of this trial, which will be evaluated from pre-operative to 3 months post-operative, is to assess the effect that RxWell has on depression levels as measured by PHQ-8 scores (Patient Health Questionnaire). Scores range from 0 - 24 where higher numbers represent increased depressive symptoms. Secondary objectives include tracking frequency, dose and type of opioid and non-opioid pain medications used for management purposes in accordance with OME measurements."
Answered by AI
Who else is applying?
What site did they apply to?
UPMC East
What portion of applicants met pre-screening criteria?
Did not meet criteria
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