Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety

NCT06865066 | Recruiting

• 1 other identifier: 6041810
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Menopause; Anxiety; Depressive/Anxiety Symptoms; Perimenopause

Keywords

Menopause; Anxiety; Online Psychotherapy; e-CBT; CBT; ACT; Menopause Transition; Digital Therapy; Perimenopause; Perimenopausal Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in symptoms (Generalized Anxiety Disorder - 7 Item)

  Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.

  Week 0, week 4, week 9, 3 and 6-month follow-up

Secondary Outcomes (7)

• Change in symptoms (Menopausal Rating Scale)

  Week 0, week 4, week 9, 3 and 6-month follow-up

• Change in symptoms (Depression Anxiety Scale - 21 Item)

  Week 0, week 4, week 9, 3 and 6-month follow-up

• Change in symptoms (The Menopause-specific Quality of Life)

  Week 0, week 4, week 9, 3 and 6-month follow-up

• Change in symptoms (Center for Epidemiologic Studies Depression Scale)

  Week 0, week 4, week 9, 3 and 6-month follow-up

• Change in symptoms (Pittsburgh Sleep Quality Index)

  Week 0, week 4, week 9, 3 and 6-month follow-up

Study Arms (1)

Online psychotherapy treatment arm

EXPERIMENTAL

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

Behavioral: e-CBT

Interventions

e-CBT BEHAVIORAL

Electronically delivered cognitive behavioural therapy with acceptance commitment therapy components

Online psychotherapy treatment arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Undergone CBT or hormone therapy within the last 6 months will be excluded
• Active psychosis
• Acute mania
• Severe alcohol or substance use disorder
• Active suicidal or homicidal ideation

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L 5G3, Canada

RECRUITING

Nazanin Alavi

Kingston, Ontario, K7L 5G3, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nazanin Alavi, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazanin Alavi, MD, FRCPC

CONTACT

613-544-3310; nazanin.alavitabari@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: This one-arm trial will deliver e-CBT for perimenopausal anxiety using the Online Psychotherapy Tool (OPTT), a secure, cloud-based digital mental health platform. All participants will be enrolled in a 9-week e-CBT/e-ACT program specifically designed to address perimenopausal anxiety. Each week, they will complete structured e-modules and homework assignments while receiving personalized feedback and asynchronous support from a therapist through the platform. The program consists of 9 weekly sessions, each containing approximately 30 e-module slides with interactive content, all delivered through OPTT. This structured approach aims to help participants effectively manage their anxiety symptoms during perimenopause.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: November 11, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)