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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

BACKGROUND: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder, with cognitive behavioral therapy (CBT) being the gold standard treatment. However, it is inaccessible and costly to many, as the mental health industry is overwhelmed by the demand for treatment. This means effective, a...

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Autores principales: Stephenson, Callum, Kumar, Anchan, Malakouti, Niloufar, Nikjoo, Niloofar, Jagayat, Jasleen, Gizzarelli, Tessa, Patel, Charmy, Gutierrez, Gilmar, Shirazi, Amirhossein, Yang, Megan, Omrani, Mohsen, Alavi, Nazanin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10551799/
https://www.ncbi.nlm.nih.gov/pubmed/37587552
http://dx.doi.org/10.2196/48899
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author Stephenson, Callum
Kumar, Anchan
Malakouti, Niloufar
Nikjoo, Niloofar
Jagayat, Jasleen
Gizzarelli, Tessa
Patel, Charmy
Gutierrez, Gilmar
Shirazi, Amirhossein
Yang, Megan
Omrani, Mohsen
Alavi, Nazanin
author_facet Stephenson, Callum
Kumar, Anchan
Malakouti, Niloufar
Nikjoo, Niloofar
Jagayat, Jasleen
Gizzarelli, Tessa
Patel, Charmy
Gutierrez, Gilmar
Shirazi, Amirhossein
Yang, Megan
Omrani, Mohsen
Alavi, Nazanin
author_sort Stephenson, Callum
collection PubMed
description BACKGROUND: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder, with cognitive behavioral therapy (CBT) being the gold standard treatment. However, it is inaccessible and costly to many, as the mental health industry is overwhelmed by the demand for treatment. This means effective, accessible, and time-saving strategies must be developed to combat these problems. Web-based interventions for mental health disorders are an innovative and promising way to address these barriers. While electronically delivered CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on mental health face-to-face has been shown to provide similar benefits to patients with anxiety disorders previously, but more research is needed to evaluate the efficacy of web-based delivery of this intervention. OBJECTIVE: This study will compare the efficacy of e-CBT and a web-based mental health check-in program to treat GAD. These programs will both be delivered through a secure, web-based care delivery platform. METHODS: We will randomly allocate participants (N=100) who are 18 years or older with a confirmed diagnosis of GAD to either an e-CBT program or a mental health check-in program over 12 weeks to address their anxiety symptoms. Participants in the e-CBT arm will complete predesigned modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the mental health check-in arm will be contacted weekly through the web-based platform’s written chat feature (messaging system). Therapists will ask the participants a series of predesigned questions that revolve around a different theme each week to prompt conversation. Using clinically validated questionnaires, the efficacy of the e-CBT arm will be compared to the mental health check-in arm. These questionnaires will be completed at baseline, week 6, and week 12. RESULTS: The study received ethics approval in April 2021, and participant recruitment began in May 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2023. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted. CONCLUSIONS: To the research team’s knowledge, this will be the first study to date comparing the efficacy of e-CBT with a web-based mental health check-in program to treat GAD. The findings from this study can help progress the development of more scalable, accessible, and efficacious mental health treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04754438; https://classic.clinicaltrials.gov/ct2/show/NCT04754438 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48899
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spelling pubmed-105517992023-10-06 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, Callum Kumar, Anchan Malakouti, Niloufar Nikjoo, Niloofar Jagayat, Jasleen Gizzarelli, Tessa Patel, Charmy Gutierrez, Gilmar Shirazi, Amirhossein Yang, Megan Omrani, Mohsen Alavi, Nazanin JMIR Res Protoc Protocol BACKGROUND: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder, with cognitive behavioral therapy (CBT) being the gold standard treatment. However, it is inaccessible and costly to many, as the mental health industry is overwhelmed by the demand for treatment. This means effective, accessible, and time-saving strategies must be developed to combat these problems. Web-based interventions for mental health disorders are an innovative and promising way to address these barriers. While electronically delivered CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on mental health face-to-face has been shown to provide similar benefits to patients with anxiety disorders previously, but more research is needed to evaluate the efficacy of web-based delivery of this intervention. OBJECTIVE: This study will compare the efficacy of e-CBT and a web-based mental health check-in program to treat GAD. These programs will both be delivered through a secure, web-based care delivery platform. METHODS: We will randomly allocate participants (N=100) who are 18 years or older with a confirmed diagnosis of GAD to either an e-CBT program or a mental health check-in program over 12 weeks to address their anxiety symptoms. Participants in the e-CBT arm will complete predesigned modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the mental health check-in arm will be contacted weekly through the web-based platform’s written chat feature (messaging system). Therapists will ask the participants a series of predesigned questions that revolve around a different theme each week to prompt conversation. Using clinically validated questionnaires, the efficacy of the e-CBT arm will be compared to the mental health check-in arm. These questionnaires will be completed at baseline, week 6, and week 12. RESULTS: The study received ethics approval in April 2021, and participant recruitment began in May 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2023. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted. CONCLUSIONS: To the research team’s knowledge, this will be the first study to date comparing the efficacy of e-CBT with a web-based mental health check-in program to treat GAD. The findings from this study can help progress the development of more scalable, accessible, and efficacious mental health treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04754438; https://classic.clinicaltrials.gov/ct2/show/NCT04754438 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48899 JMIR Publications 2023-09-20 /pmc/articles/PMC10551799/ /pubmed/37587552 http://dx.doi.org/10.2196/48899 Text en ©Callum Stephenson, Anchan Kumar, Niloufar Malakouti, Niloofar Nikjoo, Jasleen Jagayat, Tessa Gizzarelli, Charmy Patel, Gilmar Gutierrez, Amirhossein Shirazi, Megan Yang, Mohsen Omrani, Nazanin Alavi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.09.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Stephenson, Callum
Kumar, Anchan
Malakouti, Niloufar
Nikjoo, Niloofar
Jagayat, Jasleen
Gizzarelli, Tessa
Patel, Charmy
Gutierrez, Gilmar
Shirazi, Amirhossein
Yang, Megan
Omrani, Mohsen
Alavi, Nazanin
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10551799/
https://www.ncbi.nlm.nih.gov/pubmed/37587552
http://dx.doi.org/10.2196/48899
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