Amygdala and Insula Retraining for Perimenopause
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new mind-body program called Amygdala and Insula Retraining (AIR) to determine its effectiveness in reducing symptoms for individuals experiencing perimenopause. The program aims to improve issues such as sleep problems, hot flashes, fatigue, mood swings, and anxiety. Participants will either begin the AIR program immediately or after a short wait. Individuals who feel the effects of perimenopause, can read English, and have internet access may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance quality of life during perimenopause.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.
What prior data suggests that Amygdala and Insula Retraining is safe for perimenopausal individuals?
Research has shown that Amygdala and Insula Retraining (AIR) is a safe treatment option. People using AIR for a year or more have reported improvements without harmful effects, suggesting the treatment is well-tolerated over time. Although specific negative effects are not detailed in the sources, the absence of reported problems in long-term users is reassuring. As a non-drug, mind-body approach, AIR often results in fewer side effects compared to medications, making it a potentially safer choice for managing perimenopausal symptoms.12345
Why are researchers excited about this trial?
Amygdala and Insula Retraining (AIR) is unique because it targets the brain's emotional centers, specifically the amygdala and insula, which are thought to play a role in the symptoms of perimenopause. Traditional treatments for perimenopause often focus on hormone replacement therapy (HRT) to manage symptoms, but AIR offers a non-hormonal approach. This method aims to retrain the brain's response to stress and emotional triggers, potentially providing relief without the side effects associated with hormone therapies. Researchers are excited about AIR because it represents a fresh approach that could help women who are seeking alternatives to hormonal treatments.
What evidence suggests that Amygdala and Insula Retraining is effective for perimenopausal symptoms?
Research has shown that Amygdala and Insula Retraining (AIR) may help manage symptoms of chronic conditions such as chronic fatigue syndrome and fibromyalgia. Studies have found that AIR can enhance overall health and quality of life for individuals with these conditions. This method leverages neuroplasticity, the brain's ability to form new connections, to alter how the brain responds to stress and other triggers. Although specific results for perimenopause are not yet available, AIR's success in similar conditions suggests it could alleviate perimenopausal symptoms like sleep problems, tiredness, and mood swings. Early findings also indicate that AIR might improve the body's automatic functions, such as heart rate. Participants in this trial will either receive immediate access to the AIR program or continue with their usual treatment, with the option to access AIR after the primary outcome assessment.12345
Are You a Good Fit for This Trial?
This trial is for people experiencing perimenopausal symptoms who have internet access and can read English. Those with uncontrolled thyroid disease, certain cancers, severe psychiatric conditions, or who are pregnant cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the 12-week Amygdala and Insula Retraining (AIR) program or are in a wait-list control group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants in the wait-list control arm receive access to the AIR program after the primary endpoint assessment
What Are the Treatments Tested in This Trial?
Interventions
- Amygdala and Insula Retraining (AIR)
Trial Overview
The study tests Amygdala and Insula Retraining (AIR), a mind-body program aimed at reducing perimenopause symptoms, compared to a wait-list group. Participants may use wearable devices to track sleep and heart rate changes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual.
Participants receive treatment as usual for 12 weeks and are offered access to the Amygdala and Insula Retraining (AIR) program after completion of the primary outcome assessment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chronic Conditions Research Fund
Lead Sponsor
Citations
Amygdala Insula Retraining in the Management of ...
The goal of this study is to evaluate a neuroplasticity-based mind-body intervention, Amygdala and Insula Retraining (AIR), compared to a wait-list control in ...
Amygdala Insula Retraining in the Management of ...
Our research questions include: Does AIR reduce overall perimenopausal symptom burden compared to a wait-list control? Does AIR improve sleep ...
Neuroplasticity Intervention, Amygdala and Insula Retraining ...
Amygdala and Insula Retraining (AIR), otherwise known as The Gupta Program, has shown promise in recent years for treating such conditions, including ME/CFS, ...
Effectiveness of an amygdala and insula retraining program ...
Positive results from this RCT may have a significant impact on the clinical context by confirming the beneficial effect of the intervention program being ...
Amygdala Insula Retraining in the Management of ... - GoodDay
The goal of this study is to evaluate a neuroplasticity-based mind-body intervention, Amygdala and Insula Retraining (AIR), compared to a wait-list control ...
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