Mobile App for Hot Flashes

Overseen By Vanessa Muniz, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor University

Must not be taking: Hypnosis

Disqualifiers: No smartphone, Severe illness, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You can continue taking your current medications for hot flashes, but you must not change them during the study. If you are using any prescription or alternative treatments, you need to provide details and agree not to change them while participating.

What data supports the effectiveness of the treatment for hot flashes?

Research shows that hypnosis can significantly reduce hot flashes. In one study, postmenopausal women experienced a 72% decrease in hot flashes after guided self-hypnosis sessions. Another study with breast cancer survivors reported a 59% reduction in daily hot flashes and improved quality of life after hypnosis treatment. ^{1 2 3 4 5}

Is hypnosis safe for treating hot flashes?

Hypnosis is generally considered safe, but occasional adverse effects can occur in clinical and workshop settings. It's important for clinicians to be aware of and monitor these potential effects. ^{1 4 5 6 7}

How does hypnosis treatment for hot flashes differ from other treatments?

Hypnosis for hot flashes is unique because it is a non-drug, mind-body treatment that uses personalized mental imagery to help reduce symptoms. Unlike hormonal or pharmacological treatments, hypnosis involves guided sessions and self-hypnosis techniques, focusing on cool imagery to decrease the frequency and severity of hot flashes. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals experiencing hot flashes and sleep disturbances, possibly related to nocturnal eating-drinking syndrome or parasomnia. Participants must be willing to use a mobile health app daily for five weeks and provide feedback on their experience.

Inclusion Criteria

I can speak and understand English.

Ability to access the app to which the participant is randomized to (the Evia app or the Talli Care app)

I experience at least 36 hot flashes a week.

Exclusion Criteria

I am not planning to change my current medication or alternative treatments for hot flashes during the study.

Does not have access to a Smartphone

Severe or unstable medical or psychiatric illness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with a mobile health app daily for five weeks, focusing on hypnotherapy for hot flashes and sleep disturbances.

5 weeks

Remote engagement with daily app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction ratings and adverse event reporting.

1 week

Treatment Details

Interventions

• Hypnosis

Trial Overview The study is testing the effectiveness of two mobile apps designed to help reduce hot flashes and improve sleep. One app uses structured attention techniques while the other employs hypnosis. The trial will compare outcomes from using these apps over a period of five weeks.

Participant Groups

Group I: Hypnotherapy App Experimental Treatment 1 Intervention

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.

Group II: Health and habits tracker app Placebo Group 1 Intervention

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.

Hypnosis is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hypnotherapy for:

• Anxiety
• Stress Reduction
• Chronic Pain
• Sleep Disturbances
• Post-Traumatic Stress Disorder (PTSD)
• Phobias
• Eating Disorders

Approved in United States as Hypnotherapy for:

• Anxiety
• Stress Reduction
• Chronic Pain
• Sleep Disturbances
• Post-Traumatic Stress Disorder (PTSD)
• Phobias
• Eating Disorders

Approved in Canada as Hypnotherapy for:

• Anxiety
• Stress Reduction
• Chronic Pain
• Sleep Disturbances
• Post-Traumatic Stress Disorder (PTSD)
• Phobias
• Eating Disorders

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

Findings from Research

In a study involving 51 breast cancer survivors, most women preferred imagery related to coolness, particularly water imagery, to help alleviate hot flashes during hypnotherapy.

The findings suggest that incorporating patients' personal imagery preferences in hypnotherapy could enhance its effectiveness in reducing hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for hypnotic imagery for hot-flash reduction: a brief communication. Elkins, G., Marcus, J., Bunn, J., et al.[2019]

In a study involving four menopausal women, behavioral methods such as relaxation and temperature control techniques led to significant reductions in hot flash frequency, with decreases of 41% to 90% observed during the training period.

The benefits of these behavioral interventions were maintained even six months after the training, suggesting they could be effective alternatives or complements to traditional medication for managing hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple component self-control program for menopausal hot flashes. Stevenson, DW., Delprato, DJ.[2019]

A guided self-hypnosis intervention significantly reduced the frequency of hot flashes by 72% and the severity of hot flashes by 76% in a pilot study involving 13 postmenopausal women.

The study suggests that self-hypnosis could be a feasible and beneficial approach for managing hot flashes, providing a non-pharmacological option for symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of guided self-hypnosis in the treatment of hot flashes among postmenopausal women. Elkins, G., Johnson, A., Fisher, W., et al.[2015]

In a study of 60 female breast cancer survivors, a hypnosis intervention significantly reduced hot flash scores by 68% after five weekly sessions, indicating its efficacy in managing this common symptom.

Participants who received hypnosis also reported improvements in anxiety, depression, and sleep quality, suggesting that this mind-body treatment may enhance overall well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. Elkins, G., Marcus, J., Stearns, V., et al.[2020]

In a pilot study involving 16 breast cancer survivors, hypnosis led to a significant 59% reduction in daily hot flashes and a 70% decrease in weekly hot flash scores, indicating its potential effectiveness.

Patients reported improved quality of life, with notable decreases in how hot flashes interfered with daily activities, suggesting that hypnosis could be a valuable non-hormonal treatment option for managing hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors. Elkins, G., Marcus, J., Stearns, V., et al.[2007]

Hypnosis is generally a safe treatment method, but adverse effects can occur during clinical and workshop settings, highlighting the need for enhanced safety measures.

The article identifies 9 categories of adverse events that can arise in hypnosis workshops and discusses factors that may prevent these incidents from being recognized or reported, emphasizing the importance of awareness and proactive modifications to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues in the detection of those suffering adverse effects in hypnosis training workshops. Kluft, RP.[2015]

A survey of hypnosis clinicians revealed discrepancies between research evidence and actual clinical practice, particularly regarding the effectiveness of hypnosis for various conditions and the occurrence of adverse events during treatment.

The study suggests improvements in hypnosis training, including better monitoring of adverse events, enhanced methods for addressing trauma-related symptoms, and support for clinician competency development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Connections between Clinicians and Research in Hypnosis Practice: Strategies for Practice and Training. McKernan, LC., Walsh, EG.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Preferences for hypnotic imagery for hot-flash reduction: a brief communication. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Multiple component self-control program for menopausal hot flashes. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A pilot investigation of guided self-hypnosis in the treatment of hot flashes among postmenopausal women. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Issues in the detection of those suffering adverse effects in hypnosis training workshops. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Enhancing Connections between Clinicians and Research in Hypnosis Practice: Strategies for Practice and Training. [2023]