RxWell for Mood Disorders

(RxWell Trial)

Recruiting at 3 trial locations

Overseen By Carly Riedmann, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-elective surgery, Delirium, Alcoholism, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment RxWell for mood disorders?

While there is no direct evidence for RxWell, a study on an Internet-based program for bipolar disorder showed a 31% increase in social rhythm stability and a decrease in mood symptoms, suggesting that digital tools can be effective in managing mood disorders. ^{1 2 3 4 5}

Research Team

Ata Murat Kaynar, MD, MPH

Principal Investigator

UPMC Department of Anesthesiology and Perioperative Medicine

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for elective orthopedic surgery at a specified UPMC hospital.

High levels of negative affective symptoms on validated PROMIS measures

T-score greater than or equal to 60 on PROMIS Anxiety 4a short form and/or PROMIS Depression 4a short form.

Exclusion Criteria

I am experiencing severe mood swings or thoughts of harming myself that need immediate attention.

No access to a smart phone or tablet

Active delirium

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive the RxWell digital cognitive behavioral intervention and complete questionnaires via REDCap

4 weeks

Bi-weekly virtual check-ins via the RxWell app

Follow-up

Participants are monitored for pain, opioid use, and other surgical outcomes post-operatively

3 months

Post-op assessments at Day 1, Day 2, Day 7, 1 month, and 3 months

Treatment Details

Interventions

• -RxWell
• +RxWell

Trial Overview 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.

Participant Groups

Group I: Intervention: RxWell Experimental Treatment 1 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: Control Active Control 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Development of the National Network of Depression Centers Mood Outcomes Program: A Multisite Platform for Measurement-Based Care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Restoration of positive mood states in major depression as a potential drug development target. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Adjunctive strategies in the treatment of refractory bipolar depression: clinician options in the absence of a systematic database. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

An automated Internet application to help patients with bipolar disorder track social rhythm stabilization. [2019]