Amygdala Insula Retraining in the Management of Perimenopause Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age38-60
SponsorChronic Conditions Research Fund
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Experiencing perimenopausal symptoms
Meets STRAW+10 criteria based on self-assessment (-2 to +1c)
Able to read and understand English
Access to internet
Disqualifiers
Pregnancy
Presence of a severe psychiatric condition requiring immediate clinical intervention
Uncontrolled thyroid disease or prolactinoma
Active cancer treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Amygdala and Insula Retraining (AIR)
BehavioralMind-body brain retraining intervention
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Amygdala insula retrainingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Menopause Rating Scale (MRS) Total Score
Overall perimenopausal symptom burden as measured by the Menopause Rating Scale (MRS). Scale: none (0)/extremely severe (4) - higher means worse outcome
Time frame
Baseline (Week 0) to post-intervention (Week 12)Secondary outcomes
1
Greene Climacteric Scale
Overall climacteric symptom severity. Scale: not at all (0)/extremely (3) - higher means worse outcome
Time frame
Baseline (Week 0) to post-intervention (Week 12)2
Hot Flash Related Daily Interference Scale (HFRDIS)
Impact of vasomotor symptoms on daily functioning. Scale: do not interfere (0)/completely interfere (10) - higher means worse outcome
Time frame
Baseline (Week 0) to post-intervention (Week 12)3
Insomnia Severity Index (ISI)
Subjective sleep disturbance and insomnia severity. Scale: none (0)/very (4) - higher means worse outcome.
Time frame
Baseline (Week 0) to post-intervention (Week 12)4
PROMIS Fatigue Short Form 8a
Fatigue severity and impact. Scale: not at all or never (33)/ very much or always (78) - higher means worse outcome
Time frame
Baseline (Week 0) to post-intervention (Week 12)Sponsors and contacts
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Source ClinicalTrials.gov