NCT06865066 Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety
| NCT ID | NCT06865066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Nazanin Alavi |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-11-11 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Participants will complete questionnaires at the beginning, middle, and at end of the study, as well as at the three and six-month follow-up.
Eligibility Criteria
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
Contact & Investigator
Nazanin Alavi, MD, FRCPC
PRINCIPAL INVESTIGATOR
Queen's University
Frequently Asked Questions
Who can join the NCT06865066 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 60 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06865066 currently recruiting?
Yes, NCT06865066 is actively recruiting participants. Contact the research team at nazanin.alavitabari@kingstonhsc.ca for enrollment information.
Where is the NCT06865066 trial being conducted?
This trial is being conducted at Kingston, Canada, Kingston, Canada.
Who is sponsoring the NCT06865066 clinical trial?
NCT06865066 is sponsored by Dr. Nazanin Alavi. The principal investigator is Nazanin Alavi, MD, FRCPC at Queen's University. The trial plans to enroll 25 participants.