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Behavioral Intervention

Mobile App for Hot Flashes

N/A

Recruiting

Research Sponsored by Baylor University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to speak and understand English. Non-English speakers are not considered in this study because the Apps are currently only offered in English

Self-reported history of a minimum of 36 hot flashes per week at baseline

Must not have

Current use of hypnosis for any condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment (week 6)

Summary

This trial aims to compare two mobile apps that help reduce hot flashes and related symptoms. Participants will use one of the apps daily for five weeks and share their feedback and experience with the app.

Who is the study for?

This trial is for individuals experiencing hot flashes and sleep disturbances, possibly related to nocturnal eating-drinking syndrome or parasomnia. Participants must be willing to use a mobile health app daily for five weeks and provide feedback on their experience.

What is being tested?

The study is testing the effectiveness of two mobile apps designed to help reduce hot flashes and improve sleep. One app uses structured attention techniques while the other employs hypnosis. The trial will compare outcomes from using these apps over a period of five weeks.

What are the potential side effects?

Since this trial involves non-invasive interventions through mobile apps, significant side effects are not anticipated. However, participants may experience varying levels of engagement or satisfaction with the app's interface or content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak and understand English.

Select...

I experience at least 36 hot flashes a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using hypnosis for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (week 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment (week 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (week 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hot Flash Daily Diaries

Secondary study objectives

Adherence

App satisfaction and program ratings

Elkins Hypnotizability Scale-Clinical Form

+6 more

Side effects data

From 2020 Phase 4 trial • 133 Patients • NCT03075501

Dry mouth

Shakiness/Trembling

Heart racing

High heart rate and blood pressure

100%

80%

60%

40%

20%

Study treatment Arm

20mg Methamphetamine

0mg Methamphetamine (Placebo)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hypnotherapy App - EviaExperimental Treatment1 Intervention

The Evia app (https://www.eviamenopause.com/), developed by Mindset Health, provides hypnotherapy and educational resources tailored for managing hot flashes. The Evia app offers a structured 5-week program adapted from a hypnosis protocol that has been tested in various randomized clinical trials (Elkins et al., 2008; Elkins et al., 2013). During the 5-week program, users engage in daily activities such as reading brief educational materials, undergoing hypnotic sessions, and tracking their hot flashes. The app also offers users with optional hypnotherapy to improve sleep quality. The Evia app uses audio recordings to deliver hypnotherapy remotely, these are composed of mental imagery techniques focused on sensations of coolness, such as imagining cool breezes, snow, and a sense of calmness.

Group II: Health-tracker app - Talli CarePlacebo Group1 Intervention

For the health tracker app, participants will access the Talli Care app (https://talli.me/talli-care-app). The Talli Care app is a free-of-charge mobile-health application designed by Baby Logger, LLC that provides users with an interface that facilitates tracking of symptoms, physical activity, medications, water intake, and more. With the Talli Care app, participants can track their number of hot flashes, sleep quality, and additional symptoms and habits related to the management of hot flashes. Instructions regarding suggestions on what to track and how to maximize app usage will be provided to the participants by our research coordinator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypnosis

2006

Completed Phase 4

~1300

0 / 3Eligibility criteria met