Recruiting

CBT

Sponsor:

Dr. Nazanin Alavi

Code:

NCT06865066

Conditions

Menopause

Anxiety

Depressive/Anxiety Symptoms

Perimenopause

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

e-CBT

Study Details

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

Study ID

NCT06865066

Start date

Nov 11, 2024

Status verified date

Feb, 2025

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

e-CBT

Electronically delivered cognitive behavioural therapy with acceptance commitment therapy components

Primary outcome measure

  • Change in symptoms (Generalized Anxiety Disorder - 7 Item) [ Time Frame: Week 0, week 4, week 9, 3 and 6-month follow-up ]

Central Contacts and Locations

Central contacts

Nazanin Alavi, MD, FRCPC

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

Locations

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G3

Contacts

Nazanin Alavi

6479672079nazanin.alavitabari@kingstonhsc.ca

Nazanin Alavi

Recruiting

Kingston, Ontario, Canada, K7L 5G3

Contacts

Nazanin Alavi, MD, FRCPC

6479672079nazanin.alavitabari@kingstonhsc.ca

More Information

Sponsor

Dr. Nazanin Alavi

Last update posted

Mar 7, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Nazanin Alavi on 2025-03-07.