160 Participants NeededMy employer runs this trial

Amygdala and Insula Retraining for Perimenopause

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Chronic Conditions Research Fund
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Access to internet
Experiencing perimenopausal symptoms
Meets STRAW+10 criteria based on self-assessment
See 1 more

Exclusion Criteria

I do not have uncontrolled thyroid disease or prolactinoma.
I am currently receiving treatment for cancer.
Any medical or psychiatric condition that, in the judgment of the investigator or study team, would interfere with safe participation or study completion
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 12-week Amygdala and Insula Retraining (AIR) program or are in a wait-list control group

12 weeks
Conducted remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Conducted remotely

Open-label extension (optional)

Participants in the wait-list control arm receive access to the AIR program after the primary endpoint assessment

12 weeks

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

Group I: Amygdala insula retrainingExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

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 ...