RecruitingNAINTERVENTIONAL

Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety

This study is developing and testing an online therapy program specifically for women aged 40 to 60 who are experiencing anxiety during perimenopause (the time leading up to menopause). The program uses types of talk therapy called Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT). Researchers want to find out if this online program is easy to use and helpful for managing anxiety during this life stage. Participants will take part in weekly online sessions, get feedback from therapists, and fill out questionnaires to track their progress over several months. The goal is to see if this digital approach can make a real difference in reducing anxiety for these women.

At a glance

Status

Recruiting

Phase

Sponsor

Dr. Nazanin Alavi

Enrolment target

Start

11 Nov 2024

Estimated completion

28 Feb 2025

Menopause Anxiety Depressive/Anxiety Symptoms Perimenopause

What is this study about?

This research study is focused on helping women who are going through perimenopause – that's the time when your body starts changing before menopause itself. Many women experience anxiety during this period, and it can be a really challenging time.

The main idea behind this study is to create an online program that combines two well-known types of talk therapy, called Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT). These therapies teach you how to understand and change your thoughts and behaviours to manage difficult feelings like anxiety. The researchers want to see if delivering this support online can be a good way to help women cope with anxiety during their perimenopause journey. They are particularly interested in whether it's practical to use and if it actually helps to lower anxiety levels.

By finding effective and accessible ways to support women during perimenopause, this study hopes to improve their well-being. It's an important step towards understanding how online tools can be used to provide mental health support during a significant time of life.

Key takeaways

Tests online therapy (CBT/ACT) for perimenopausal anxiety.
For women aged 40-60 in perimenopause with anxiety.
Involves weekly online sessions and feedback from therapists.
Participation includes filling out questionnaires over several months.
Confidential and you can withdraw at any time.

Who may be eligible?

This study is looking for women between 40 and 60 years old who are currently in the perimenopausal stage. This means they are experiencing the natural changes that happen before their periods stop completely, which a doctor will be able to confirm. You also need to have been diagnosed with a type of anxiety called Generalised Anxiety Disorder (GAD) by a specialist involved in the research.

To take part, you must have been assigned female at birth, be able to understand and speak English, and have reliable access to the internet. It's also important that you are able to give your full permission to join the study.

However, if you've recently had other types of therapy like CBT or hormone therapy (within the last 6 months), or if you have certain other mental health conditions like severe depression, psychosis, severe addiction issues, or are having thoughts of harming yourself or others, this study might not be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 40 and 60 years old?
Are you currently going through perimenopause (beginning of menopause transition)?
Have you been diagnosed with Generalised Anxiety Disorder (GAD)?
Do you have regular and reliable internet access?
Have you NOT had CBT or hormone therapy in the last six months?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be one of about 25 women taking part. The main part of your participation will involve weekly online sessions. These sessions will be part of an online therapy program called e-CBT, which is specially designed for anxiety during perimenopause. You'll work through different parts of the program each week.

You won't be alone in this – you'll get regular feedback on your work from trained healthcare providers. This will all happen through a secure online platform, so you can do it from the comfort of your home. You'll also be asked to fill out questionnaires at several points: when you start the study, halfway through, and at the end. After the study finishes, they'll check in with you again with more questionnaires at three months and six months to see how you're doing.

Potential risks and benefits

Participating in this study might offer you the potential benefit of learning new ways to manage your anxiety through proven therapy techniques, delivered conveniently online. While generally considered safe, some people might find discussing their anxiety challenging, or the amount of time involved in the assessments and therapy might feel demanding. It's really important to remember that if you join, you have the right to withdraw from the study at any time, for any reason, without needing to explain why, and it won't affect any medical care you receive.

Locations (2)

Kingston General Hospital
Verified postcode
Kingston, Canada· Recruiting
Nazanin Alavi
Verified postcode
Kingston, Canada· Recruiting

Common questions

What is perimenopause?

Perimenopause is the natural transition period leading up to menopause, when your body starts making less of certain hormones, and your periods become irregular before eventually stopping.

What is e-CBT?

e-CBT stands for electronic Cognitive Behavioural Therapy. It's a type of talk therapy delivered online, helping you change unhelpful thoughts and behaviours to manage anxiety.

Will I have to pay to join the study?

No, you will not have to pay to participate in this research study.

How long will the online program last?

The study involves weekly online sessions, and questionnaires will be completed over several months, including follow-ups at three and six months after the main part of the study.

Who will see my information?

Your information will be kept confidential and handled securely. Only authorized staff involved in the research will have access to your study data.

How to find out more

Nazanin Alavi, MD, FRCPC

nazanin.alavitabari@kingstonhsc.ca 613-544-3310 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.