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NCT07873177
Pilot RCT for Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Conditions: Menopause, Menopausal Vasomotor Symptoms
Sex: Female
Ages: 40 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: St. Joseph's Healthcare Hamilton
Location: St. Joseph's Healthcare Hamilton Hamilton Ontario
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.
Eligibility Criteria
Inclusion Criteria:
* women and individuals assigned female at birth (AFAB) aged 40-65 years of age;
* subjective distressing vasomotor symptoms (a score of 30 or higher on the Hot Flash Rating Scale);
* residing in Canada;
* fluent in English;
* access to, and comfort with, the internet and a computer;
* not currently engaged in psychotherapy;
* not taking hormonal or psychotropic medication or if taking medication, stable in type and dose for 8 weeks prior to study and stable for duration of the study
Exclusion Criteria:
* participants with severe depression (as a score of 15 and over on the PHQ-9 or active suicidal ideation or psychotic symptoms;
* participants with a severe mental health disorder requiring in-person therapy (e.g., severe substance abuse, recent history of psychosis or mania);
* participants with an unstable general medical condition;
* participants with cognitive impairment that would limit comprehension or ability to engage with the online program.
Source: ClinicalTrials.gov (NCT07873177). StuddyBuddy aggregates publicly available trial information.