NCT06718803

A Mobile App for Hot Flashes and Sleep Disturbances

A Mobile App for Hot Flashes and Sleep Disturbances (Evia): Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Baylor University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the possible efficacy and acceptability of two mobile health applications for the reduction of hot flashes and related symptoms.This study is completely remote, and participants will be be asked to engage with a mobile health application daily for five weeks and provide feedback and experience with the app.

Detailed description

The North American Menopause Society's 2023 position statement on non-hormonal interventions for hot flashes has recognized hypnotherapy as a Level 1 recommended intervention, meaning there is good and consistent scientific evidence for the intervention. Hypnotherapy for hot flashes has been shown to be an efficacious treatment for hot flashes (hot flashes measured by hot flash daily diaries and the Hot Flash Related Daily Interference Scale) when administered face-to-face, with women experiencing on average between 70% reductions in hot flashes, which is well over the clinically significant threshold of 50% reduction. In addition, hypnotherapy for hot flashes has been shown to improve sleep quality by up to 50% on average. Further, a mobile app (Evia) has been developed by Mindset Health to deliver hypnotherapy for hot flashes. Evia is an app that delivers a 5-week program for hypnotic inductions and educational information for hot flashes. The app provides daily tasks such as educational readings, hypnotic inductions, and tracking hot flashes. Due to growth in smartphone ownership and an increase in remotely delivered mobile health (mHealth) apps for smartphones, it is clear that smartphone apps are a strategic way to increase access to hypnosis interventions for hot flashes. However, there has not yet been a randomized controlled trial evaluating the mobile app for hot flash reduction in menopausal women. The goal of this feasibility randomized clinical trial study is to evaluate the feasibility and potential efficacy of hypnotherapy delivered through the use of a mHealth app vs. a daily health and habit-tracker app for the reduction of hot flashes and improved sleep quality. This proposal delineates three specific aims. Aim 1: To assess the feasibility of remote accrual of menopausal women with at least 36 weekly hot flashes, randomization to both apps, and retention. Aim 2: To assess the feasibility of data collection, and the potential efficacy of hypnotherapy on primary and secondary outcomes (i.e., hot flash diaries, interference caused by hot flashes, physiologically-measured hot flash frequency, sleep quality, anxiety, heart palpitations, stress). Aim 3: To evaluate the satisfaction rating and adverse events. After using the apps for 5 weeks, participants will provide satisfaction ratings on a 0-10 scale (0=completely unsatisfied and 10=completely satisfied. We will also inquire about and record any reported adverse events related to or unrelated to the use of this study's apps. Aim 4: To explore the feasibility of measuring hypnotizability and practice adherence in a completely remote, mhealth app-based study.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
BEHAVIORAL	Hypnosis	The Evia program includes three mayor components, 1. A hypnotherapy program for the reduction of hot flashes, 2. Educational readings on hot flashes and menopausal-related topics, 3. Daily hot flash tracker. The hypnotherapy is delivered in short, daily 10-20 minute audio recordings that involve numerous suggestions for coolness and relaxation (i.e., cool breeze, snowy mountain, deep lake) for a period of five weeks. The hypnotherapy program is based on previous randomized controlled trials for the reduction of hot flashes (Elkins et al., 2008; Elkins et al., 2013).
OTHER	Structured Attention	Data collection of hot flash severity and frequency will mirror the hot flashes daily tracker offered by the intervention group (Evia app), and account for time and structured attention control while removing any potential therapeutic effects.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-08-21
• Completion: 2025-08-21
• First posted: 2024-12-05
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States