A Mobile App for Hot Flashes and Sleep Disturbances (Evia): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Hot Flash Daily Diaries
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hypnosis (Behavioral)
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.
结局指标
主要结局
Hot Flash Daily Diaries
时间窗: 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.
次要结局
- Heart Palpitations(From enrollment to the end of treatment (week 6))
- 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))
- Perceived Stress Scale(From enrollment to the end of treatment (week 6))
- App satisfaction and program ratings(End of treatment (week 6))
- Adherence(From enrollment to the end of treatment (week 6))
- Elkins Hypnotizability Scale-Clinical Form(End of treatment (week 6))
研究者
Vanessa Muniz
Principal Investigator
Baylor University