Internet-Delivered Cognitive Behaviour Therapy for Women with Perimenopausal Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorDr. Nazanin Alavi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Undergone CBT or hormone therapy within the last 6 months will be excluded
Active psychosis
Acute mania
Severe alcohol or substance use disorder
Trial design
Design model
Single group
Treatments tested in this trial
e-CBT
BehavioralElectronically delivered cognitive behavioural therapy with acceptance commitment therapy components
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Online psychotherapy treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in symptoms (Generalized Anxiety Disorder - 7 Item)
Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.
Time frame
Week 0, week 4, week 9, 3 and 6-month follow-upSecondary outcomes
1
Change in symptoms (Menopausal Rating Scale)
Clinically validated symptom questionnaire. Scale of 0-4, 4 being the worst level of severity
Time frame
Week 0, week 4, week 9, 3 and 6-month follow-up2
Change in symptoms (Depression Anxiety Scale - 21 Item)
Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.
Time frame
Week 0, week 4, week 9, 3 and 6-month follow-up3
Change in symptoms (The Menopause-specific Quality of Life)
Clinically validated symptom questionnaire. Scale of 0-6, 6 being the worst level of severity
Time frame
Week 0, week 4, week 9, 3 and 6-month follow-up4
Change in symptoms (Center for Epidemiologic Studies Depression Scale)
Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst level of severity
Time frame
Week 0, week 4, week 9, 3 and 6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Nazanin Alavi
Lead sponsor
Queen's University
Sponsor institution
Source ClinicalTrials.gov