Clinical trial NCT06718803: A Mobile App for Hot Flashes and Sleep Disturbances
Official title: A Mobile App for Hot Flashes and Sleep Disturbances (Evia): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hot Flashes
Keywords: Hypnosis
post-menopausal
mhealth
apps
hypnotherapy
hot flashes
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hot Flash Daily Diaries
timeFrame: From enrollment to the end of treatment (week 6)
Secondary outcomes:
measure: Hot Flash Related Daily Interference Scale
timeFrame: From enrollment to the end of treatment (week 6)
measure: Pittsburgh Sleep Quality Index
timeFrame: From enrollment to the end of treatment (week 6)
measure: Leeds Sleep Evaluation Questionnaire
timeFrame: End of treatment (week 6)
measure: Hospital Anxiety Sub Scale
timeFrame: From enrollment to the end of treatment (week 6)
measure: Heart Palpitations
timeFrame: From enrollment to the end of treatment (week 6)
measure: Perceived Stress Scale
timeFrame: From enrollment to the end of treatment (week 6)
measure: App satisfaction and program ratings
timeFrame: End of treatment (week 6)
measure: Adherence
timeFrame: From enrollment to the end of treatment (week 6)
measure: Elkins Hypnotizability Scale-Clinical Form
timeFrame: End of treatment (week 6)
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
References: