A Mobile App for Hot Flashes and Sleep Disturbances

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.

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).

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).

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).

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 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.

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.

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.

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.

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).