NCT04754438

Comparing the Efficacy of E-CBT to Mental Health Coaching for GAD

Completed NA Last updated 18 October 2024

What this trial tests

NA trial testing e-CBT in Anxiety in 96 participants. Completed in 30 December 2023.

Timeline

1 April 2021

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Dr. Nazanin Alavi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	1 April 2021
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• e-CBT
• Mental Health Coaching

Conditions studied

• Anxiety — all drugs for Anxiety →
• Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →

Sponsor

Dr. Nazanin Alavi

Who can join

Adults 18 to 65, any sex, with Anxiety or Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will compare the efficacy of an electronically-delivered cognitive behavioural therapy (e-CBT) program versus a mental health coaching program to treat generalized anxiety disorder (GAD). This randomized trial intervention will provide the e-CBT and mental health coaching for GAD through a secure, online platform. Participants will be between the ages of 18 and 65 years with a confirmed diagnosis of GAD according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5). Participants will either be offered an e-CBT program tailored to GAD or an online mental health coaching program over 12 weeks to address their anxiety symptoms. e-CBT participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the coaching group will be contacted weekly through the online platform's chat feature. Therapists will ask the participants a series of pre-designed questions that revolve around a different theme each week to prompt conversation. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared to the coaching group. These questionnaires will be completed at baseline, week 6, week 12, and at a 6-month follow-up. Questionnaires include the State-Trait Anxiety Inventory (STAI), the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), the Generalized Anxiety Disorder - 7 Item (GAD-7), and the Depression Anxiety Stress Scale - 42 Item (DASS-42).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparing the Efficacy of Electronically Delivered Cognitive Behavioral Therapy (e-CBT) to Weekly Online Mental Health Check-Ins for Generalized Anxiety Disorder-A Randomized Controlled Trial: Comparaison de l'efficacité de la thérapie cognitivo-comportementale délivrée par voie
   Chermahini MB, Eadie J, Agarwal A, Stephenson C, et al · · 2024 · cited 3× · PMID 39033431 · DOI 10.1177/07067437241261933
2. Comparing the Efficacy of an Electronically Delivered Cognitive Behavioral Therapy Program to a Mental Health Check-In Program for Generalized Anxiety Disorder: Protocol for a Randomized Trial.
   Stephenson C, Kumar A, Malakouti N, Nikjoo N, et al · · 2023 · PMID 37587552 · DOI 10.2196/48899