MenopauseICBT-Meno-VSNCT07873177
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Menopause and Menopausal Vasomotor Symptoms, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause, Menopausal Vasomotor Symptoms
- What is being tested?
- Internet-delivered Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2026to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle W Chow, MSc contact
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8P 3R2
Sheryl M Green, PhD, CPsych, 905-522-1155 ext. Ext. 33672, sgreen@stjoes.ca
Sheryl M Green, PhD, CPsych
About this study
Official title: A Pilot Randomized Controlled Trial: Internet-Delivered Cognitive Behavioural Therapy Program for Menopausal Vasomotor Symptoms
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.
Read more
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.
- Conditions
- Menopause, Menopausal Vasomotor Symptoms
- Being tested
- Internet-delivered Cognitive Behavioural Therapy
- Keywords
- Menopause, Menopausal Vasomotor Symptoms, Cognitive Behavioural Therapy, Internet-delivered Cognitive Behavioural Therapy, Hot flashes, Night sweats
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavioural TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICBT-Meno-VS | Experimental | Individual 4-week online CBT-based program Receives: Other: Internet-delivered Cognitive Behavioural Therapy |
| Waitlist ICBT-Meno-VS | Other | Four-week waitlist, followed by the ICBT-Meno-VS program Receives: Other: Internet-delivered Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Recruitment rates, reflecting the portion of individuals that express interest and enroll in the study, will provide information about our recruitment process and whether this is sufficient for conducting the study. This will be calculated as a percentage of the proportion of individuals who express interest in the study and subsequently enroll.
Measured: Measured through the recruitment period (up to 12 months)
Feasibility: Eligibility Rate
Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention, including the eligibility rate. Eligibility rate will be calculated as the proportion in percentage of screened individuals who meet inclusion and exclusion criteria.
Measured: Measured through the recruitment period (up to 12 months)
Feasibility: Homework Completion
Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Homework completion will be used to assess engagement with treatment components. Homework completion will be assessed as the proportion of assigned homework tasks completed during the intervention period.
Measured: Measured during the treatment period, from the first to last session (up to 4 weeks)
Feasibility: Treatment Completion Rate
Treatment completion rates will indicate whether the treatment is feasible for a menopausal population. Treatment completion will be defined as the proportion of participants who complete 4 out of 4 lessons.
Measured: Measured at the end of treatment (4 weeks)
Feasibility: Retention Rate
Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Retention rates (i.e., continued participation in study assessments - baseline, post-treatment, 3-month follow-up), will provide information about the feasibility of collecting outcome data over time.
Measured: Measured at baseline (at enrolment, 0 weeks), post-treatment (4 weeks), and 3-month follow-up (20 weeks)
Acceptability: Treatment Credibility/ Expectancy (TCQ)
The Treatment Credibility instrument is a 4-item survey used to measure the participant's experience with the program and whether it helped them achieve their wellbeing goals. Items on the questionnaire are rated on a 10-point Likert scale, where 10 represents 'very confident', 'very logical', or 'very successful'.
Measured: Administered immediately at the end of the 4-week treatment
Acceptability: Internet-CBT Treatment Satisfaction Measure (ICBT-TS)
The ICBT-TS is a post-treatment program satisfaction questionnaire used to assess participants' satisfaction with the internet-delivered CBT program and to evaluate treatment acceptability. The questionnaire will consist of forced-choice items related to course satisfaction (i.e., treatment platform, lessons, and overall program), rated on a 5-point Likert scale ranging from 1 (Very Dissatisfied) to 5 (Very Satisfied). Additional yes/no items will assess whether participants would recommend the course to a friend, whether they experienced any negative effects during the course, and whether the course was perceived as worth their time. Consistent with prior internet-delivered treatment studies, the ICBT-TS will include 19 items assessing overall program satisfaction and acceptability.
Measured: Administered immediately at the end of the 4-week treatment
Acceptability: measured using a Brief Qualitative Interview
At one-week post-treatment, participants will attend a brief qualitative interview to review treatment progress and provide feedback on their care, including what aspects of the treatment were helpful and what could be improved, as well as feedback on the length of treatment and its delivery. This does not include a specific number or scale, rather, qualitative feedback on the treatment and their care will be reported on.
Measured: Administered one week after finishing the treatment
Secondary outcomes (8)
Hot Flash Related Daily Interference Scale (HFRDIS)
The HFRDIS is a validated scale which assesses the level of vasomotor interference in daily activities. Total scores range from 0-100, with scores of 30 or greater suggesting clinically significant interference related to vasomotor symptoms. Higher scores indicate greater symptom severity.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Greene Climacteric Scale (GCS)
The GCS is a validated 21-item self-report measure assessing menopausal symptom severity across psychological, somatic, vasomotor, and sexual domains. Items are rated on a 4-point scale from 0 ("not at all") to 3 ("extremely"), with higher scores indicating greater symptom severity. Vasomotor symptoms will be assessed using the vasomotor subscale (GCS-VM), which includes hot flashes and night sweats and yields total scores ranging from 0 to 6, with scores of 3 or greater indicating clinically significant vasomotor symptom severity. Sexual concerns will be assessed using the sex-specific item ("loss of interest in sex"), scored from 0 to 3.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Hot Flush Behaviour Scale (HFBehS)
The HFBehS is an 11-item self-report measure that assesses behaviors used to manage or respond to vasomotor symptoms during the menopausal transition. The scale comprises three subscales assessing behavioral avoidance, cooling behaviors, and positive coping behaviors. Items are rated based on the frequency of these responses, with higher scores indicating greater endorsement of each behavior type.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Hot Flush Beliefs Scale (HFBS)
The HFBS is a 27-item measure designed to assess beliefs and appraisals related to hot flashes and night sweats. The scale includes three domains: beliefs about the self in a social context (HFBSSelf; e.g., "When I have a hot flush, other people will think I am incompetent"), beliefs about coping with hot flashes (HFBS-HF; e.g., "When I have a hot flush, I think when will they ever end", and beliefs about coping with night sweats (HFBS-NS; e.g., "When I have night sweats, it is harder to cope the next day"). Items are rated on a Likert-type scale, with higher scores reflecting more negative or unhelpful beliefs about vasomotor symptoms.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 contains 9 items that measure depression symptoms over the past 2 weeks based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PHQ, in the form of a self-report questionnaire (Kroenke et al., 2001) Total scores range from 0-27, where higher scores indicate greater severity of depression symptoms, and a total score of ≥ 10 is widely considered a standard for major depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period (Spitzer et al., 2006). Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder (Spitzer et al., 2006).
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire that assesses sleep quality via the nature, severity, and impact of insomnia (Morin, 1993; Bastien et al., 2001). Items are scored on a 5-point Likert scale ranging from 0 ('no problem') to 4 ('very severe problem') with higher scores reflecting greater insomnia severity. Total scores between 0-7 indicate an absence of insomnia; scores between 8-14 suggest sub-threshold insomnia; scores between 15-21 indicate moderate insomnia; and scores between 22-28 suggest severe insomnia.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Menopause-Related Quality of Life (MENQOL)
The MENQOL is a 29-item self-report measure assessing menopause-related quality of life across vasomotor, psychosocial, physical, and sexual domains. Items assess symptom-related bother over the past month on a 7-point Likert scale, with higher scores indicating poorer quality of life.
Measured: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start13 Oct 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active intervention vs. waitlist control
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl M Green, PhD, CPsych, Principal investigator, St. Joseph's Healthcare HamiltonMichelle W Chow, MSc, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873177
- Sponsor's protocol ID
- 19665
- Acronym
- ICBT-Meno-VS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No