A Mobile App for Hot Flashes and Sleep Disturbances

NCT06718803 | Completed

• 1 other identifier: 2220078
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hot Flash Daily Diaries

  Hot flash frequency and hot flash scores will be measured using hot flash daily diaries (Sloan et al., 2001) to assess the feasibility of the intervention for the reduction of hot flashes compared to a structured attention control condition. Hot flash daily diaries are a reliable measure of hot flash frequency and severity most commonly used in prior randomized control trials using hypnotherapy for hot flash treatment (Barton et al., 2017; Elkins et al., 2008; Elkins et al., 2013; MacLaughlan et al., 2013). In hot flash daily diaries, participants are asked to document their daily experiences of hot flashes as they occur by categorizing their symptom severity (mild, moderate, severe, and very severe). A participant's hot flash score is computed by adding the product of frequency x severity of hot flashes in each category.

  From enrollment to the end of treatment (week 6)

Secondary Outcomes (9)

• Hot Flash Related Daily Interference Scale

  From enrollment to the end of treatment (week 6)

• Pittsburgh Sleep Quality Index

  From enrollment to the end of treatment (week 6)

• Leeds Sleep Evaluation Questionnaire

  End of treatment (week 6)

• Hospital Anxiety Sub Scale

  From enrollment to the end of treatment (week 6)

• Heart Palpitations

  From enrollment to the end of treatment (week 6)

Study Arms (2)

Hypnotherapy App

EXPERIMENTAL

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.

Behavioral: Hypnosis

Health and habits tracker app

PLACEBO COMPARATOR

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 BEHAVIORAL

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).

Also known as: hypnotherapy, hypnotic relaxation therapy, clinical hypnosis

Hypnotherapy App

Structured Attention OTHER

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Does not have access to a Smartphone
• Severe or unstable medical or psychiatric illness.
• Current use of hypnosis for any condition.

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University

Waco, Texas, 76706, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: January 10, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)