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Not recruiting

Mobile App

Sponsor:

Baylor University

Code:

NCT06718803

Conditions

Hot Flashes

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Hypnosis

Structured Attention

Study Details

Brief 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.

Conditions

Hot Flashes

Study ID

NCT06718803

Start date

Jan, 2025

Status verified date

Jan, 2025

Completion date

May, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 40 years or older and able to consent to participate in the study.
  • 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.

Exclusion Criteria:

  • New or changes in the current use of any prescription or complementary and alternative medicine (CAM) treatments for hot flashes during the duration of the intervention. \[If the participant is already using any prescription or CAM, they will be asked to provide details of ingredients, dose and frequency. They will be permitted to participate in the study if they agree to no change for the duration of their participation in the study and otherwise meet inclusion criteria.\]
  • Does not have access to a Smartphone
  • Severe or unstable medical or psychiatric illness.
  • Current use of hypnosis for any condition.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

Primary outcome measure

  • Hot Flash Daily Diaries [ Time Frame: From enrollment to the end of treatment (week 6) ]

Central Contacts and Locations

Central contacts

Vanessa Muniz, MA

(956)645-8109Vanessa_muniz1@baylor.edu

Keith Sanford, PhD

(254) 710-2256keith_sanford@baylor.edu

Locations

Baylor University

Recruiting

Waco, Texas, United States, 76706

Contacts

Vanessa Muniz, MA

(254) 307-1006mindbody@baylor.edu

More Information

Sponsor

Baylor University

Last update posted

Jan 10, 2025

Last verified

Jan, 2025

Keywords

  • Hypnosis
  • post-menopausal
  • mhealth
  • apps
  • hypnotherapy
  • hot flashes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Baylor University on 2025-01-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.