Amygdala Insula Retraining in the Management of Perimenopause Symptoms

NCT07427459 | Recruiting

• 1 other identifier: CCRF-AIR-PM
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Perimenopause

Keywords

Amygdala and Insula Retraining (AIR)

Outcome Measures

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

  Baseline (Week 0) to post-intervention (Week 12)

Secondary Outcomes (8)

• Greene Climacteric Scale

  Baseline (Week 0) to post-intervention (Week 12)

• Hot Flash Related Daily Interference Scale (HFRDIS)

  Baseline (Week 0) to post-intervention (Week 12)

• Insomnia Severity Index (ISI)

  Baseline (Week 0) to post-intervention (Week 12)

• PROMIS Fatigue Short Form 8a

  Baseline (Week 0) to post-intervention (Week 12)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline (Week 0) to post-intervention (Week 12)

Study Arms (2)

Amygdala insula retraining

EXPERIMENTAL

Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual.

Behavioral: Amygdala and Insula Retraining (AIR)

Control

NO INTERVENTION

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.

Interventions

Amygdala and Insula Retraining (AIR) BEHAVIORAL

Mind-body brain retraining intervention

Amygdala insula retraining

Eligibility Criteria

• Age: 38 Years - 61 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Experiencing perimenopausal symptoms
• Meets STRAW+10 criteria based on self-assessment
• Able to read and understand English
• Access to internet

You may not qualify if:

• 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

Sponsors & Collaborators

• Chronic Conditions Research Fund: lead

Study Sites (1)

Luther College Department of Psychology

Decorah, Iowa, 52101, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)