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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to design an online Cognitive Behavioural Therapy (CBT) and Acceptance Commitment Therapy (ACT) program and to learn if it can treat anxiety in women transitioning into menopause (perimenopause). The main questions it aims to answer are: * Is our online psychotherapy program a practical and acceptable means of managing anxiety during perimenopause? * Does our online psychotherapy program work in improving anxiety levels during perimenopause? Participants will participate in weekly e-CBT module sessions tailored to perimenopausal anxiety and will be given weekly feedback on assignments from trained care providers through a secure online platform. Participants will complete questionnaires at the beginning, middle, and at end of the study, as well as at the three and six-month follow-up.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• In perimenopausal staging (as defined by the STRAW +10 criteria)

• Assigned female at birth

• Diagnosis of GAD according to DSM-5 by attending psychiatrist on research team

• Competence to consent to participate

• Ability to speak and read English

• Consistent and reliable access to the internet

Locations
Other Locations
Canada
Kingston General Hospital
RECRUITING
Kingston
Nazanin Alavi
RECRUITING
Kingston
Contact Information
Primary
Nazanin Alavi, MD, FRCPC
nazanin.alavitabari@kingstonhsc.ca
613-544-3310
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 25
Treatments
Experimental: Online psychotherapy treatment arm
All participants will receive access to e-CBT modules offered through the Online Psychotherapy Tool (OPTT) and will be paired with an online careprovider, who is trained to administer online CBT and ACT. Following the structure of previous e-CBT modules developed by the QUOPL team, the module for this study will be designed to mirror standard in-person CBT for Generalized Anxiety Disorder and will combine components of ACT. Weekly homework will be assigned and evaluated by the participant's designated care provider, who will provide personalized feedback on the online platform (OPTT), acknowledging their module completion and homework
Related Therapeutic Areas
Sponsors
Leads: Dr. Nazanin Alavi

This content was sourced from clinicaltrials.gov