Actively Recruiting

Phase Not Applicable
Age: 40Years - 60Years
FEMALE
ID06865066

Developing an Internet-Delivered Cognitive Behaviour Therapy Program for Women with Perimenopausal Anxiety: a Feasibility and Acceptability Study

Led by Dr. Nazanin Alavi · Updated on 2025-03-07

25

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to develop and test an online psychotherapy program combining Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT) to manage anxiety in women going through perimenopause. The study focuses on whether this online approach is practical and acceptable, and if it can effectively improve anxiety symptoms during this transitional stage. Participants are women aged 40 to 60 years experiencing perimenopause as defined by specific medical criteria, and diagnosed with Generalized Anxiety Disorder (GAD). Participants will access weekly e-CBT modules tailored to address perimenopausal anxiety, delivered through a secure online platform called the Online Psychotherapy Tool (OPTT). Each session covers specific topics related to menopause and anxiety management, including mindfulness, acceptance, thought records, and sleep hygiene. Weekly homework will be assigned and personalized feedback provided by trained care providers. The program lasts nine weeks, and participants can interact with their care providers via the platform. Throughout the study, participants will complete validated questionnaires about anxiety, menopause symptoms, stress, sleep quality, depression, and quality of life at five points: start, midpoint, end, and three and six months after treatment. Data confidentiality is strictly maintained, with de-identified information stored securely. Additionally, some participants will take part in post-study interviews to share their experiences and feedback. The total study duration covers initial assessment, nine weeks of treatment, and follow-up evaluations.

CONDITIONS

Brief Title

Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety

Who Can Participate

Age: 40Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • In perimenopausal staging as defined by the STRAW +10 criteria
  • Assigned female at birth
  • Diagnosis of Generalized Anxiety Disorder by an attending psychiatrist
  • Competent to consent to participate
  • Able to speak and read English
  • Have consistent and reliable access to the internet
Not Eligible

You will not qualify if you...

  • Received cognitive behavioural therapy or hormone therapy within the last 6 months
  • Have active psychosis
  • Have acute mania
  • Have severe alcohol or substance use disorder
  • Have active suicidal or homicidal thoughts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 virtual screening and enrollment visit

Outpatient Treatment

Duration - 9 weeks

Participants engage in weekly internet-delivered cognitive behavioural therapy sessions with acceptance commitment therapy components, including weekly homework assignments and personalized feedback from an online care provider.

Weekly virtual therapy sessions for 9 weeks

Follow-up

Duration - 6 months

Participants complete follow-up questionnaires to assess symptom changes and program feedback at 3 and 6 months after treatment completion.

2 follow-up assessments at 3 and 6 months post-treatment

Trial Site Locations

Total: 2 locations

1

Kingston General Hospital

Kingston, Ontario, Canada, K7L 5G3

Actively Recruiting

2

Nazanin Alavi

Kingston, Ontario, Canada, K7L 5G3

Actively Recruiting

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Research Team

N

Nazanin Alavi, MD, FRCPC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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