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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the RxWell app to help manage mood disorders, such as anxiety and depression, in patients undergoing knee or hip replacement surgery. Some participants will use the RxWell app alongside standard care, while others will receive only standard care. The researchers aim to determine if the app can improve recovery and reduce healthcare costs by helping patients manage their mood. Suitable candidates for this trial are those undergoing elective knee or hip surgeries and experiencing moderate mood disorder symptoms. As an unphased trial, this study offers patients the opportunity to explore innovative ways to enhance their recovery and well-being.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RxWell, a digital tool for cognitive behavioral therapy (CBT), is generally safe for use. Studies have found that users tolerate it well. For instance, RxWell led to significant improvements in anxiety and depression without major side effects. In one study, users experienced a noticeable drop in anxiety and depression levels from the start of the study to one month later, with improvements continuing for up to three months. This indicates that RxWell is both effective and safe for those seeking help with mood disorders. Overall, evidence supports RxWell as a safe option for managing anxiety and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RxWell because it offers a digital approach to managing mood disorders through cognitive behavioral therapy (CBT), which is delivered via a smartphone app. Unlike traditional treatments for anxiety and depression, such as medications or in-person therapy, RxWell provides accessible and on-demand support, allowing users to engage with therapeutic techniques anytime, anywhere. This convenience and flexibility can lead to better adherence and engagement, potentially enhancing treatment outcomes for individuals who might not otherwise access conventional care. Additionally, RxWell's integration of regular assessments through tools like the GAD-7 and PHQ-8 allows for continuous monitoring and personalized adjustments in care, which is a novel feature compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for mood disorders?

Research has shown that the RxWell app, which employs digital cognitive-behavioral techniques, can significantly reduce anxiety and depression. In earlier studies, participants using the RxWell program reported feeling better within one to three months. The app has effectively helped manage anxiety and depression before surgeries and in individuals with stomach-related issues. Additionally, using RxWell has led to noticeable improvements in anxiety levels, underscoring its potential as a powerful tool for mood management. In this trial, participants in the intervention arm will receive the RxWell app alongside standard care, while those in the control arm will receive standard care and education about potential resources for anxiety and depression. These findings suggest that RxWell could be a valuable resource for those dealing with mood disorders. ^{1 2 4 6 7}

Who Is on the Research Team?

Ata Murat Kaynar, MD, MPH

Principal Investigator

UPMC Department of Anesthesiology and Perioperative Medicine

Are You a Good Fit for This Trial?

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

I have a severe intellectual disability.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.202200045

A Digital Cognitive-Behavioral Intervention for Depression ... The dCBI app was associated with a significant reduction in anxiety and depression at 1 and 3 months. A dCBI is feasible as part of routine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10601399/

Telemedicine-Based Digital Cognitive Behavioral ... Conclusion: These preliminary data suggest that the use of a RxWell® program represents an effective approach to control anxiety and depression prior to surgery ...

3. journals.lww.com journals.lww.com/ctg/fulltext/2021/12000/a_coached_digital_cognitive_behavioral.3.aspx

A Coached Digital Cognitive Behavioral Intervention ... A coached digital cognitive behavioral intervention reduces anxiety and depression in adults with functional gastrointestinal disorders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8751763/

A Coached Digital Cognitive Behavioral Intervention Reduces ... We found that RxWell use was associated with statistically and clinically significant differences between baseline anxiety scores and anxiety ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07634-0

SuRxgWell: study protocol for a randomized controlled trial of ... It carries the potential of reducing depression, anxiety, pain catastrophizing, and postsurgical pain in patients undergoing total arthroplasty ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10069502/

Efficacy of a digital mental health intervention embedded in ... This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed ...

7. mdpi.com mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ... Digital CBT tools are expected to provide long-term treatment outcomes that are comparable to those of traditional face-to-face therapy. The hypothesis is that ...