Online therapy for anxiety in women going through menopause
Developing an Internet-Delivered Cognitive Behaviour Therapy Program for Women with Perimenopausal Anxiety: a Feasibility and Acceptability Study
This study is testing an online therapy program to see if it can help women going through menopause feel less anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Queen's University Academic / other |
| Locations | 2 sites (Kingston, Ontario and 1 other locations) |
| Trial ID | NCT06865066 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop and evaluate an online Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT) program specifically designed for women experiencing anxiety during perimenopause. Participants will engage in weekly e-CBT sessions tailored to their needs and receive feedback from trained care providers through a secure online platform. The study will assess the program's practicality and effectiveness in reducing anxiety levels through questionnaires administered at various stages of the trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-60 who are experiencing perimenopausal anxiety as defined by the STRAW +10 criteria.
Not a fit: Patients with active psychosis, acute mania, severe substance use disorders, or those who have undergone CBT or hormone therapy in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide an accessible and effective treatment option for managing anxiety in women during the perimenopausal transition.
How similar studies have performed: Other studies have shown promise in using online psychotherapy for anxiety management, suggesting that this approach could be effective, though this specific application for perimenopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingston, Ontario and 1 other locations
- Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)
- Nazanin Alavi — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Nazanin Alavi, MD, FRCPC — Queen's University
- Study coordinator: Nazanin Alavi, MD, FRCPC
- Email: nazanin.alavitabari@kingstonhsc.ca
- Phone: 613-544-3310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.