A Mobile App for Hot Flashes and Sleep Disturbances

Not Applicable

Recruiting

• Conditions: Hot Flashes

• Registration Number: NCT06718803
• Lead Sponsor: Baylor University

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.

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-01
• Study Start: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hot Flash Daily Diaries	From enrollment to the end of treatment (week 6)	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.

Secondary Outcome Measures

Name	Time	Method
Hot Flash Related Daily Interference Scale	From enrollment to the end of treatment (week 6)	Daily-life interference caused by hot flashes will be assessed using the Hot Flash Related Daily Interference Scale (HFRDIS; Carpenter et al., 2001). The HFRDIS is a 10-item scale that asks respondents to rate, on a 0-10 scale, the degree to which hot flashes interfere with various daily activities and overall enjoyment or quality of life. This measure has been shown to be valid and internally consistent, with an alpha of .96 (Carpenter et al., 2001). The HFRDIS will be administered at all measurement points (baseline and post-treatment).
Pittsburgh Sleep Quality Index	From enrollment to the end of treatment (week 6)	The Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989), a 19-item self-report questionnaire, will be administered to the participants across all three measurement points to evaluate sleep quality. Previous research demonstrates significant correlations between PSQI total scores and measures such as sleep onset latency, time spent awake after initial sleep onset, and total sleep time recorded by sleep diary and wrist actigraphy (Mollayeva et al., 2016). The PSQI will be administered at all measurement points (baseline and post-treatment).
Leeds Sleep Evaluation Questionnaire	End of treatment (week 6)	The Leeds Sleep Evaluation Questionnaire (LSEQ; Parrott \& Hindmarch, 1980) is a 10-item questionnaire that measures different dimensions of sleep and early morning behavior for the assessment of changes in sleep due to a treatment intervention. The scale was first introduced and validated in a clinical trial for the efficacy of temazepam for sleep quality and improved early morning behavior (Hindmach, 1975).
Hospital Anxiety Sub Scale	From enrollment to the end of treatment (week 6)	Anxiety will be measured using the Hospital Anxiety Sub Scale (HADS; Zigmond \& Snaith, 1983). The HADS-A is a 7-item self-report measure of patients' generalized anxiety over the past week. The HADS-A has shown internal consistency in previous studies with Cronbach's alphas ranging from .68-.93 and a mean of .83. It has also been shown to be correlated with other self-report measures of anxiety. The HADS-A will be administered at all measurement points (baseline and post-treatment).
Heart Palpitations	From enrollment to the end of treatment (week 6)	Heart palpitations will be measured using a single-item baseline questionnaire. Women will be asked to rate their distress associated with "heart racing or pounding" in the past two weeks. The questionnaire will have five options, in which participants can select from "not at all" (0) to "extremely" (5). However, any indication of heart palpitations (ratings of 1 through 5) will be entered as a "yes" for palpitation distress in data analysis.
Perceived Stress Scale	From enrollment to the end of treatment (week 6)	The Perceived Stress Scale (PSS; Cohen, 1983) is a 10-item scale that will be measuring the participants' stress before and after the intervention period. The scale provides the degree to which individuals find different situations of their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0-4 with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83 (Cohen, 1983). This scale will be administered at baseline and post-treatment.
App satisfaction and program ratings	End of treatment (week 6)	Participants will be asked to rate their overall level of satisfaction with the app they used. A 10- point VAS scale (Wewers \& Lowe, 1990) anchored with 0 "Completely Dissatisfied" to 10 "Completely Satisfied" will be given after 5 weeks of use. In order to assess participants' perceptions of the value of the app they receive, they will be asked, "How do you rate this app program overall regarding ease of use?" and "How do you rate this app program overall in regard to improving your hot flashes?" Responses will be given on a 10-point scale ranging from 1 (poor) to 10 (excellent) after completing 5 weeks of use.
Adherence	From enrollment to the end of treatment (week 6)	Participants will be instructed to interact daily with the apps. Mindset Health will provide a log of user activity for data on adherence to the Evia app. In addition, the RAs will be inquiring on all participants' frequency of daily use during the weeks 1 through 5 phone calls. The research coordinator will closely monitor accrual and retention in addition to adverse events.; Participants who drop out of the study will be contacted and given an opportunity to respond to an Exit Checklist to identify their reasons for dropping out.
Elkins Hypnotizability Scale-Clinical Form	End of treatment (week 6)	Hypnotizability will be measured using the Elkins Hypnotizability Scale-Clinical Form (EHS-CF; Elkins, 2013). The EHS-CF is a standardized hypnotizability scale that is remotely administered using a Zoom call. The EHS-CF will be administered by a trained graduate student. The EHS-CF is highly correlated with longer measures of hypnotizability and has excellent validity and reliability in both a general and clinical population (Kekecs et al., 2016; Zimmerman et al., 2024). The EHS-CF takes approximately 20 minutes to administer and will be administered after the intervention. Those in the control condition will not complete the EHS-CF as they will not have any exposure to hypnosis (the EHS-CF involves a hypnotic induction).

Trial Locations

Locations (1)

Baylor University; 🇺🇸 Waco, Texas, United States