Caria: Digital Intervention for Menopause Symptom

Overseen By Jennifer Duffecy, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

150 Participants Needed

Trial Summary

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 seems focused on using a mobile app to manage menopause symptoms, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What data supports the effectiveness of the Caria app and Menopause Education treatment?

Research shows that patients' expectations can significantly influence treatment outcomes. This suggests that if users of the Caria app and Menopause Education have positive expectations, they may experience better results, similar to findings in other medical conditions where expectation-focused interventions improved outcomes. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a mobile app aimed at helping women manage menopause symptoms. The app uses education, goal setting, motivation, social support, and cognitive behavioral techniques. Women will report their symptoms and quality of life at different stages of using the app.

Research Team

Jennifer Duffecy, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

) by 66% of women If you experience hot flashes or night sweats that are problematic (average score of 2 or higher on three items of the Hot Flush Rating Scale), then 66% of women will experience the same thing.

The person has an elevated score on at least one measure of depression, sleep, or anxiety.

You have an Apple device able to run the Caria app.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Caria app for menopause symptom management, including education, goal setting, and cognitive behavioral techniques

6 weeks

Self-report assessments at baseline, 3 weeks, and 6 weeks

Follow-up

Participants are monitored for changes in menopause symptoms and quality of life after app usage

4 weeks

Treatment Details

Interventions

• Caria app
• Menopause Education

Participant Groups

Group I: Caria app Experimental Treatment 1 Intervention

The Caria app is publically available on the Apple app store. It is an interactive native app that provides education on menopause as well as symptom tracking/feedback features, social support as well as cognitive behavioral and relaxation techniques. Participants will be given an "unlocked" version with all content available at no charge. The app sends out occasional automated emails to users to remind of features of the app and to encourage them to return to the app. Users can opt out of reminder features.

Group II: Menopause education Active Control 1 Intervention

Participants will receive educational material about menopause from the North American Menopause Society, a well respected menopause organization.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Chorus Health

Collaborator

Trials

1

Recruited

150+

References

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

Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain. [2021]

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

Expectation-Focused Psychotherapy to Improve Clinical Outcomes. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Measuring outcomes in trials of interventions for people who self-harm: qualitative study of service users' views. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Placebo, an underestimated ally]. [2015]

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

Changes Over a Decade in Patient-Reported Outcome Measures and Minimal Clinically Important Difference Reporting in Total Joint Arthroplasty. [2023]