What this trial studies
The goal of this clinical trial is to design an online Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT) program and to learn if it can treat anxiety in women transitioning into menopause (perimenopause). The main questions it aims to answer are: * Is our online psychotherapy program a practical and acceptable means of managing anxiety during perimenopause? * Does our online psychotherapy program work in improving anxiety levels during perimenopause? Participants will participate in weekly e-CBT module sessions tailored to perimenopausal anxiety and will be given weekly feedback on assignments from trained care providers through a secure online platform.
Conditions in scope
- Menopause
- Anxiety
- Depressive/Anxiety Symptoms
- Perimenopause
Interventions
- e-CBT (Behavioral) — Electronically delivered cognitive behavioural therapy with acceptance commitment therapy components
Who can join
Women only · Ages 40 Years to 60 Years
Inclusion criteria
- In perimenopausal staging (as defined by the STRAW +10 criteria)
- Assigned female at birth
- Diagnosis of GAD according to DSM-5 by attending psychiatrist on research team
- Competence to consent to participate
- Ability to speak and read English
- Consistent and reliable access to the internet
Exclusion criteria
- Undergone CBT or hormone therapy within the last 6 months will be excluded
- Active psychosis
- Acute mania
- Severe alcohol or substance use disorder
- Active suicidal or homicidal ideation
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Kingston | Ontario | Kingston General Hospital | Recruiting |
| Kingston | Ontario | Nazanin Alavi | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2024-11-11
- Primary completion: 2025-02-28
- Last update posted: 2025-03-07
- First posted: 2025-03-07
Sponsor & contact
Lead sponsor: Dr. Nazanin Alavi (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in symptoms (Generalized Anxiety Disorder - 7 Item) (Week 0, week 4, week 9, 3 and 6-month follow-up)
Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06865066 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.