Clinical trial for Mood Disorders
Official title RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty
ClinicalTrials.gov ID: NCT05658796
What this study is testing
- What it's testing
- This study is looking at whether using the RxWell platform can improve recovery after knee or hip surgery.
- Who it's for
- You may be able to join if you are having a knee or hip replacement and have mood concerns like anxiety or depression.
- What's involved
- You would use the RxWell app on your phone to manage mood before and after surgery. You may also have a few check‑in visits with the study team.
- Time commitment
- The study lasts about the time of your surgery and recovery, with a few visits before and after the operation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Monroeville, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Monroeville, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.