Internet-Delivered Cognitive Behavioural Therapy for Hot Flashes

(ICBT-Meno-VS Trial)

SM
MW
Overseen ByMichelle W Chow, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online cognitive behavioral therapy (CBT) program designed to manage hot flashes and night sweats during menopause. The researchers aim to determine if participants find the program easy to use at home and if it improves symptoms, sleep, mood, anxiety, and quality of life. Participants will either start the program immediately or wait four weeks before beginning. Suitable candidates for this trial are individuals assigned female at birth, aged 40-65, living in Canada, experiencing bothersome hot flashes, and comfortable using the internet. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance quality of life during menopause.

What prior data suggests that this online program is safe for managing menopause-related symptoms?

Previous studies have shown that cognitive behavioral therapy (CBT) is safe and well-tolerated by participants. Research indicates that CBT can manage symptoms like hot flashes and night sweats during menopause without major side effects. As a non-drug treatment, CBT avoids the side effects often associated with medications. Participants frequently feel more in control of their symptoms and report an improved quality of life. This suggests that the online CBT program for hot flashes is likely a safe option for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about Internet-delivered Cognitive Behavioural Therapy (ICBT) for hot flashes because it offers a unique, accessible approach compared to traditional methods like hormone replacement therapy and medications. Unlike these standard treatments, which often involve in-person visits and potential side effects, ICBT is an online program that can be completed from the comfort of home. This delivery method makes it particularly appealing for individuals seeking a non-pharmacological and convenient solution to manage their symptoms. Additionally, its structured, cognitive-behavioral approach may provide long-lasting coping strategies for managing hot flashes.

What evidence suggests that this internet-delivered cognitive behavioural therapy is effective for managing hot flashes?

Research has shown that cognitive behavioral therapy (CBT) can lessen the intensity of hot flashes and night sweats. Studies have found that both in-person and online CBT effectively manage these symptoms. In this trial, participants will receive the Internet-delivered Cognitive Behavioural Therapy program either immediately or after a waitlist period. An online CBT program has proven promising and practical for easing menopausal symptoms. While CBT does not reduce the frequency of these symptoms, it makes them feel less bothersome. Specifically, previous patients reported improvements not only in hot flashes but also in mood and sleep. These findings suggest that online CBT could be a useful tool for those experiencing menopausal symptoms.678910

Who Is on the Research Team?

MW

Michelle W Chow, MSc

Principal Investigator

McMaster University

SM

Sheryl M Green, PhD, CPsych

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

This trial is for people experiencing hot flashes and night sweats related to menopause. Participants should be able to use the internet, complete online activities, and meet briefly with a guide each week. Specific inclusion or exclusion criteria are not detailed.

Inclusion Criteria

I am a woman or AFAB and between 40 and 65 years old.
I am not taking hormonal or psychotropic drugs, or my dose has been stable for 8 weeks.
Fluent in English
See 4 more

Exclusion Criteria

I do not have cognitive issues that prevent me from using an online program.
Participants with severe depression defined 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 such as severe substance abuse, recent history of psychosis or mania
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 12 months

Treatment

Participants complete a four-week therapist-guided online CBT-based program for menopause-related hot flashes and night sweats

4 weeks
4 weekly online sessions

Follow-up

Participants complete follow-up questionnaires to assess the maintenance of treatment effects

3 months
Follow-up assessments at post-treatment and 3 months later

What Are the Treatments Tested in This Trial?

Interventions

  • Internet-delivered Cognitive Behavioural Therapy

Trial Overview

The study tests a four-week, therapist-guided online cognitive behavioural therapy (CBT) program designed to help manage menopausal hot flashes and night sweats. Some participants start right away; others wait four weeks before beginning.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Waitlist ICBT-Meno-VSExperimental Treatment1 Intervention
Group II: ICBT-Meno-VSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

Citations

Cognitive behavioural therapy for menopausal symptoms - PMC

[44] demonstrated that face-to-face CBT, particularly group-based therapy, was effective in reducing vasomotor symptoms like hot flushes and night sweats, as ...

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The study found that both in-person and telephone counseling using cognitive-behavioral therapy (CBT) effectively reduced hot flashes and night sweats to a ...

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CBT tailored for menopause may improve insomnia, hot flashes, and mood. New research highlights benefits—and the need for strategies to sustain improvements ...

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These findings suggest that an Internet-based CBT program for women with treatment-induced menopausal symptoms is feasible and promising in terms of efficacy.

COGNITIVE BEHAVIORAL THERAPY

Cognitive behavioral therapy has been shown to reduce the degree to which hot flashes and night sweats are rated as a problem. CBT does not change the frequency ...

CBT for Menopause When HRT Is Not an Option | TMC

Hot Flushes and Night Sweats: While CBT may not eliminate hot flushes entirely, it significantly reduces how problematic they feel. Women learn ...

Study explores benefits of cognitive behavioural therapy for ...

Mindfulness and cognitive behavioural therapy (CBT) could be effective in treating non-physiological symptoms of the menopause, ...

Pilot Randomized Controlled Trial for Internet-Delivered ...

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- ...

Cognitive behavioural interventions for the treatment of ...

Hot flushes and night sweats (HF/NS), the main physical symptoms experienced during the menopause transition, tend to be problematic for approximately ...

How CBT Can Support Women With Menopause

CBT has been shown to be effective. It can also help to manage the impact of hot flashes and night sweats. such as hot flashes, can lead us to ...