Actively Recruiting
Developing an Internet-Delivered Cognitive Behaviour Therapy Program for Women with Perimenopausal Anxiety: a Feasibility and Acceptability Study
Led by Dr. Nazanin Alavi · Updated on 2025-03-07
25
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to develop and test an online psychotherapy program combining Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT) to manage anxiety in women going through perimenopause. The study focuses on whether this online approach is practical and acceptable, and if it can effectively improve anxiety symptoms during this transitional stage. Participants are women aged 40 to 60 years experiencing perimenopause as defined by specific medical criteria, and diagnosed with Generalized Anxiety Disorder (GAD). Participants will access weekly e-CBT modules tailored to address perimenopausal anxiety, delivered through a secure online platform called the Online Psychotherapy Tool (OPTT). Each session covers specific topics related to menopause and anxiety management, including mindfulness, acceptance, thought records, and sleep hygiene. Weekly homework will be assigned and personalized feedback provided by trained care providers. The program lasts nine weeks, and participants can interact with their care providers via the platform. Throughout the study, participants will complete validated questionnaires about anxiety, menopause symptoms, stress, sleep quality, depression, and quality of life at five points: start, midpoint, end, and three and six months after treatment. Data confidentiality is strictly maintained, with de-identified information stored securely. Additionally, some participants will take part in post-study interviews to share their experiences and feedback. The total study duration covers initial assessment, nine weeks of treatment, and follow-up evaluations.
CONDITIONS
Brief Title
Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- In perimenopausal staging as defined by the STRAW +10 criteria
- Assigned female at birth
- Diagnosis of Generalized Anxiety Disorder by an attending psychiatrist
- Competent to consent to participate
- Able to speak and read English
- Have consistent and reliable access to the internet
You will not qualify if you...
- Received cognitive behavioural therapy or hormone therapy within the last 6 months
- Have active psychosis
- Have acute mania
- Have severe alcohol or substance use disorder
- Have active suicidal or homicidal thoughts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual screening and enrollment visit
Duration - 9 weeks
Participants engage in weekly internet-delivered cognitive behavioural therapy sessions with acceptance commitment therapy components, including weekly homework assignments and personalized feedback from an online care provider.
Weekly virtual therapy sessions for 9 weeks
Duration - 6 months
Participants complete follow-up questionnaires to assess symptom changes and program feedback at 3 and 6 months after treatment completion.
2 follow-up assessments at 3 and 6 months post-treatment
Trial Site Locations
Total: 2 locations
1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 5G3
Actively Recruiting
2
Nazanin Alavi
Kingston, Ontario, Canada, K7L 5G3
Actively Recruiting
Research Team
N
Nazanin Alavi, MD, FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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