Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pilot RCT for Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Sponsor: St. Joseph's Healthcare Hamilton
Summary
Given the impact that hot flashes and night sweats can have on daily life during the menopausal transition, our team has developed a therapist-guided online cognitive behavioural therapy (CBT)- based program to help individuals manage these symptoms. An online program may help address systemic barriers to in-person care, such as cost, time, travel, and caregiving needs. The broad aim of this pilot clinical trial is to examine the experience of a four-week therapist-guided online CBT-based program for menopause-related hot flashes and night sweats. The primary objective of this study is to evaluate the acceptability and feasibility of the four-week online program, including how participants experience the program and how well they are able to complete it at home. The secondary objective is to explore whether the program may help with hot flashes and night sweats, and related concerns such as sleep, mood, anxiety, and quality of life. Exploratory analyses will examine whether changes in these outcomes are maintained three months after completing the program. Researchers will compare participants who receive the program immediately with participants who wait four weeks before receiving it. Participants will: * Complete online questionnaires about their symptoms and well-being. * Complete four weekly online lessons and activities. * Meet briefly with a guide each week for guidance and support. * Complete follow-up questionnaires after the program and three months later.
Official title: Pilot Randomized Controlled Trial for Internet-Delivered Cognitive Behavioural Therapy Program for Menopausal Vasomotor Symptoms
Key Details
Gender
FEMALE
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-10-13
Completion Date
2028-08-31
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Internet-delivered Cognitive Behavioural Therapy
This study is a randomized waitlist-controlled pilot study. The ICBT-Meno-VS program is based on CBT-Meno, a structured CBT protocol and accompanying workbook developed to help individuals manage menopause-related symptoms, including vasomotor symptoms, mood, sleep, and anxiety (Green et al., 2012; Green et al., 2019). The ICBT-Meno-VS program adapts these CBT-based strategies for delivery through an online, therapist-guided format and focuses on managing menopause-related vasomotor symptoms. Eligible participants will be randomly assigned to receive the 4-week ICBT-Meno-VS program immediately or to a 4-week waitlist. Participants assigned to the intervention group will complete the 4-week ICBT-Meno-VS program, followed by a post-treatment assessment, and a 3-month follow-up assessment. Participants assigned to the waitlist will complete a 4-week waitlist period and assessment, after which they will receive the 4-week ICBT-Meno-VS program, followed by a post-treatment assessment.
Locations (1)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada