Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2025-01-10
2025-08-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hypnotherapy App
Participants in the experimental arm will be asked to engage with a mobile health app that provides hypnotherapy and educational resources tailored for managing hot flashes. The hypnotherapy 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 hypnotherapy 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.
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).
Health and habits tracker app
Participants assigned to the comparator group will be asked to engage with a daily health and habits tracker app, participants will access the control app free-of-charge, and will be asked to use the app for the five-week period. The app provides users with an interface that facilitates tracking of symptoms, physical activity, medications, and more. Participants will be asked to 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. Data will not be collected from the app.
No interventions assigned to this group
Interventions
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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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Self-reported history of a minimum of 36 hot flashes per week at baseline.
* Ability to access the app to which the participant is randomized to (the Evia app or the Talli Care app).
* Ability to speak and understand English. Non-English speakers are not considered in this study because the Apps are currently only offered in English.
* Does not have access to a Smartphone
* Severe or unstable medical or psychiatric illness.
* Current use of hypnosis for any condition.
40 Years
FEMALE
No
Sponsors
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Baylor University
OTHER
Responsible Party
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Vanessa Muniz
Principal Investigator
Locations
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Baylor University
Waco, Texas, United States
Countries
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Other Identifiers
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2220078
Identifier Type: -
Identifier Source: org_study_id
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