Authorised Therapeutic use (Phase IV) Insomnia

Sleeping through Menopause

Q: Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Q: Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

Q: How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Q: Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

EU CTIS ID: 2024-512071-12-00

What this study is testing

This study aims to evaluate effectiveness of stand alone MHT and a guided online CBTi with CRS on insomnia and depressive symptoms in perimenopausal women. Additionally, the added effect of a combination of MHT and guided online CBTi and CRS will be evaluated on the same outcome measurements. This study aims to ameliorate mental health complaints and improve well-being in perimenopausal women.

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Age between 40-55 years old
Insomnia severity index score =>10
Green Climacteric Score =>13
Self-considered capability of completing online questionnaires and diaries in Dutch and English
Presence of a menstrual cycle (<1yr since last menstruation)

You likely can't join if

CBTi treatment in past 3 months
Bipolar disorder or psychotic disorder
Contra-indication for Menopausal Hormonal Therapy
Use of hormonal contraceptives
Women using thyroid medication of lamotrigine
Women already on MHT

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.