Amygdala Insula Retraining in the Management of Perimenopause Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amygdala and Insula Retraining (AIR).
- Who it may be relevant to
- Registry conditions: Perimenopause, Menopausal Complaints. Basic parameters: 38 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 individuals experiencing perimenopausal symptoms. Our research questions include: Does AIR reduce overall perimenopausal symptom burden compared to a wait-list control? Does AIR improve sleep disturbance, vasomotor symptom interference, fatigue, mood, anxiety, and quality of life in perimenopausal individuals? Are symptom changes associated with improvements in autonomic regulation and sleep parameters, as reflected by exploratory wearable measures including heart rate variability?
Detailed description
Perimenopause is a transitional reproductive stage marked by fluctuations in ovarian steroid hormones. It is often associated with sleep disruption, fatigue, mood changes, anxiety, cognitive changes, and diminished quality of life. Emerging evidence suggests that, in addition to hormonal changes, alterations in central threat processing, interoception, and autonomic nervous system regulation may contribute to symptom amplification and persistence during this period.
Amygdala and Insula Retraining (AIR) is a structured, neuroplasticity-based behavioral intervention designed to modulate the autonomic nervous system. The program integrates cognitive reframing, somatic retraining, mindfulness practices, breathwork, behavioral pattern interruption, and safety-signal conditioning with the aim of calming hyper-reactive limbic pathways. Through repeated practice, AIR seeks to restore autonomic balance and reduce symptom burden.
This study is a 24-week, parallel-group, randomized, wait-list-controlled trial conducted remotely. A minimum of 160 perimenopausal participants aged 38 to 60 years will be randomized in a 1:1 ratio to either an active intervention arm or a wait-list control arm. Participants in the active intervention arm will receive immediate access to the 12-week AIR program in addition to treatment as usual. Participants in the wait-list control arm will continue treatment as usual for 12 weeks and will receive access to the recorded AIR intervention following completion of the primary endpoint assessment. Both groups will be followed through week 24.
The primary assessment is the the Menopause Rating Scale (MRS) total score from baseline (T0) to post-intervention at week 12 (T1). Secondary outcomes, assessed at baseline, week 12, and week 24, include insomnia severity, fatigue, anxiety, depression, patient global impression of change, and sexual function (optional). Concomitant therapies, including hormone replacement therapy and relevant medications, will be recorded at all assessment time points.
An exploratory wearable sub-study will be conducted in a randomly selected subset of approximately 50 participants distributed across both study arms. Wearable devices will be used to collect objective physiological measures, including heart rate variability, resting heart rate, sleep duration and efficiency, and activity metrics. These data will be analyzed descriptively to explore potential physiological correlates of symptom change.
Interventions
- Behavioral Amygdala and Insula Retraining (AIR)
Mind-body brain retraining intervention
Primary outcome measures
- Menopause Rating Scale (MRS) Total Score [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
Secondary outcome measures (8)
- Greene Climacteric Scale [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- Hot Flash Related Daily Interference Scale (HFRDIS) [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- Insomnia Severity Index (ISI) [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- PROMIS Fatigue Short Form 8a [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline (Week 0) to post-intervention (Week 12)]
- Patient Global Impression of Change (PGIC) [Time frame: Assessed at Weeks 12 and 24]
- Female Sexual Function Index (FSFI) [Time frame: Baseline (Week 0) to post-intervention (Week 12) (optional)]
Eligibility criteria
Inclusion criteria
- Experiencing perimenopausal symptoms
- Meets STRAW+10 criteria based on self-assessment (-2 to +1c)
- Able to read and understand English
- Access to internet
Exclusion criteria
- Pregnancy
- Presence of a severe psychiatric condition requiring immediate clinical intervention
- Uncontrolled thyroid disease or prolactinoma
- Active cancer treatment
- Inability to provide informed consent
- Any medical or psychiatric condition that, in the judgment of the investigator or study team, would interfere with safe participation or study completion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Luther College Department of Psychology — Decorah
Identifiers
NCT: NCT07427459 · CCRF-AIR-PM