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1.
Can J Psychiatry ; 69(9): 695-707, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39033431

RESUMO

BACKGROUND: Generalized anxiety disorder (GAD) is a prevalent anxiety disorder characterized by uncontrollable worry, trouble sleeping, muscle tension, and irritability. Cognitive behavioural therapy (CBT) is one of the first-line treatments that has demonstrated high efficacy in reducing symptoms of anxiety. Electronically delivered CBT (e-CBT) has been a promising adaptation of in-person treatment, showing comparable efficacy with increased accessibility and scalability. Finding further scalable interventions that can offer benefits to patients requiring less intensive interventions can allow for better resource allocation. Some studies have indicated that weekly check-ins can also lead to improvements in GAD symptoms. However, there is a lack of research exploring the potential benefits of online check-ins for patients with GAD. OBJECTIVE: This study aims to investigate the effects of weekly online asynchronous check-ins on patients diagnosed with GAD and compare it with a group receiving e-CBT. METHODS: Participants (n e-CBT = 45; n check-in = 51) with GAD were randomized into either an e-CBT or a mental health check-in program for 12 weeks. Participants in the e-CBT program completed pre-designed modules and homework assignments through a secure online delivery platform where they received personalized feedback from a trained care provider. Participants in the mental health check-in condition had weekly asynchronous messaging communication with a care provider where they were asked structured questions with a different weekly theme to encourage conversation. RESULTS: Both treatments demonstrated statistically significant reductions in GAD-7-item questionnaire (GAD-7) scores over time, but when comparing the groups there was no significant difference between the treatments. The number of participants who dropped out and baseline scores on all questionnaires were comparable for both groups. CONCLUSIONS: The findings support the effectiveness of e-CBT and mental health check-ins for the treatment of GAD. PLAIN LANGUAGE SUMMARY TITLE: Comparing the Effectiveness of Electronically Delivered Therapy (e-CBT) to Weekly Online Mental Health Check-ins for Generalized Anxiety Disorder-A Randomized Controlled Trial.


Generalized anxiety disorder (GAD) is a prevalent psychiatric condition that leads to symptoms like uncontrollable worry, trouble sleeping, muscle tension, and irritability. Cognitive behavioural therapy (CBT) is a common psychotherapy used for GAD since it has been shown to reduce symptoms. However, traditional CBT that is in person can have barriers such as being inaccessible and costly, and therefore electronically delivered CBT (e-CBT) is a viable alternative since previous studies have shown its efficacy in reducing symptoms and being similar compared to face-to-face CBT. Previous studies have also shown reductions in GAD symptomology through the use of checking in on people and their mental health. Therefore, this study aimed to compare e-CBT to a check-in condition and had a total of 45 individuals in e-CBT and 51 participants in the check-in condition. Participants in the e-CBT condition completed 12 weeks of predesigned e-CBT modules, homework and received personalized feedback from a care provider. In contrast, individuals in the check-in condition completed 12 weeks of unstructured asynchronous messaging with a care provider. Results from the study showed that both the e-CBT and check-in condition demonstrated statistically significant improvements in GAD-7 across time, but when comparing the groups there was no significant difference. The results show the efficacy of e-CBT and checking in on people's mental health to reduce GAD and future research should examine the 2 conditions combined.


Assuntos
Transtornos de Ansiedade , Terapia Cognitivo-Comportamental , Intervenção Baseada em Internet , Humanos , Transtornos de Ansiedade/terapia , Terapia Cognitivo-Comportamental/métodos , Adulto , Feminino , Masculino , Pessoa de Meia-Idade , Telemedicina , Avaliação de Resultados em Cuidados de Saúde , Adulto Jovem
2.
JMIR Ment Health ; 11: e51704, 2024 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-38173167

RESUMO

BACKGROUND: Depression is a hidden burden, yet it is a leading cause of disability worldwide. Despite the adverse effects of depression, fewer than one-third of patients receive care. Internet-based cognitive behavioral therapy (i-CBT) is an effective treatment for depression, and combining i-CBT with supervised care could make the therapy scalable and effective. A stepped care model is a framework for beginning treatment with an effective and low-intensity intervention while adapting care based on the patient's needs. OBJECTIVE: This study investigated the efficacy of a stepped care i-CBT model for depression based on changes in self-reported depressive symptoms. METHODS: In this single-blinded, randomized controlled trial, participants were allocated to either the i-CBT-only group (28/56, 50%) or the i-CBT with stepped care group (28/56, 50%). Both groups received a 13-week i-CBT program tailored for depression. The i-CBT program was provided through a secure, online mental health clinic called the Online Psychotherapy Tool. Participants read through the sessions and completed the assignments related to each session. Participants in the stepped care group received additional interventions from their care provider based on standard questionnaire scores (ie, Patient Health Questionnaire-9 [PHQ-9], Quick Inventory of Depressive Symptomatology [QIDS], and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) and their assignment responses. From lowest to highest intensity, the additional interventions included SMS text messages, phone calls, video calls, or a video call with a psychiatrist. RESULTS: For this study, 56 participants were recruited to complete an i-CBT program (n=28, 50%; mean age 37.9; SD 13.08 y; 7/28, 27% were men) or an i-CBT with stepped care program (n=28, 50%; mean age 40.6; SD 14.28 y; 11/28, 42% were men). The results of this study indicate that the i-CBT program was effective in significantly reducing depressive symptoms, as measured by the PHQ-9 (F4,80=9.95; P<.001) and QIDS (F2,28=5.73; P=.008); however, there were no significant differences in the reduction of depressive symptoms between the 2 groups (PHQ-9: F4,80=0.43; P=.78; QIDS: F2,28=3.05; P=.06). The stepped care group was not significantly better in reducing depressive symptoms than the i-CBT group (PHQ-9, P=.79; QIDS, P=.06). Although there were no significant differences observed between the number of participants who completed the program between the groups (χ21=2.6; P=.10), participants in the stepped care group, on average, participated in more sessions than those who prematurely terminated participation in the i-CBT group (t55=-2; P=.03; 95% CI -4.83 to -0.002). CONCLUSIONS: Implementing a stepped care approach in i-CBT is an effective treatment for depression, and the stepped care model can assist patients to complete more sessions in their treatment. TRIAL REGISTRATION: Clinicaltrials.gov NCT04747873; https://clinicaltrials.gov/study/NCT04747873.


Assuntos
Terapia Cognitivo-Comportamental , Depressão , Masculino , Humanos , Adulto , Feminino , Depressão/terapia , Qualidade de Vida , Terapia Cognitivo-Comportamental/métodos , Psicoterapia/métodos , Internet
3.
Front Psychiatry ; 14: 1194955, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38125282

RESUMO

Background: Generalized anxiety disorder (GAD) is a debilitating mental health disorder with first-line treatments include cognitive behavioral therapy (CBT) and pharmacotherapy. CBT is costly, time-consuming, and inaccessible. Electronic delivery (e-CBT) is a promising solution to address these barriers. However, due to the novelty of this intervention, more research testing the e-CBT efficacy independently and in conjunction with other treatments is needed. Objective: This study investigated the efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD. Methods: This study employed a quasi-experimental design where patients selected their preferred treatment modality. Patients with GAD were enrolled in either e-CBT, medication, or combination arms. The 12-week e-CBT program was delivered through a digital platform. The medications followed clinical guidelines. The efficacy of each arm was evaluated using questionnaires measuring depression, anxiety, and stress severity, as well as quality of life. Results: There were no significant differences between arms (N e-CBT = 41; N Medication = 41; N Combination = 33) in the number of weeks completed or baseline scores. All arms showed improvements in anxiety scores after treatment. The medication and combination arms improved depression scores. The e-CBT and Combination arms improved quality of life, and the combination arm improved stress scores. There were no differences between the groups in depression, anxiety, or stress scores post-treatment. However, the combination arm had a significantly larger improvement in quality of life. Gender and treatment arm were not predictors of dropout, whereas younger age was. Conclusion: Incorporating e-CBT on its own or in combination with pharmaceutical interventions is a viable option for treating GAD. Treating GAD with e-CBT or medication appears to offer significant improvements in symptoms, with no meaningful difference between the two. Combining the treatments also offer significant improvements, while not necessarily superior to either independently. The findings suggest that all options are viable. Taking the patient's preferred treatment route based on their lifestyle, personality, and beliefs into account when deciding on treatment should be a priority for care providers.

4.
JMIR Res Protoc ; 12: e48899, 2023 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-37587552

RESUMO

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.

5.
Front Psychiatry ; 14: 1113956, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37187863

RESUMO

Objective: The increased prevalence of major depressive disorder (MDD) amid the COVID-19 pandemic has resulted in substantial growth in online mental health care delivery. Compared to its in-person counterpart, online cognitive behavioral therapy (e-CBT) is a time-flexible and cost-effective method of improving MDD symptoms. However, how its efficacy compares to in-person CBT is yet to be explored. Therefore, the current study compared the efficacy of a therapist-supported, electronically delivered e-CBT program to in-person therapy in individuals diagnosed with MDD. Methods: Participants (n = 108) diagnosed with MDD selected either a 12 week in-person CBT or an asynchronous therapist-supported e-CBT program. E-CBT participants (n = 55) completed weekly interactive online modules delivered through a secure cloud-based online platform (Online Psychotherapy Tool; OPTT). These modules were followed by homework in which participants received personalized feedback from a trained therapist. Participants in the in-person CBT group (n = 53) discussed sessions and homework with their therapists during one-hour weekly meetings. Program efficacy was evaluated using clinically validated symptomatology and quality of life questionnaires. Results: Both treatments yielded significant improvements in depressive symptoms and quality of life from baseline to post-treatment. Participants who opted for in-person therapy presented significantly higher baseline symptomatology scores than the e-CBT group. However, both treatments demonstrated comparable significant improvements in depressive symptoms and quality of life from baseline to post-treatment. e-CBT seems to afford higher participant compliance as dropouts in the e-CBT group completed more sessions on average than those in the in-person CBT group. Conclusion: The findings support e-CBT with therapist guidance as a suitable option to treat MDD. Future studies should investigate how treatment accessibility is related to program completion rates in the e-CBT vs. in-person group. Clinical Trial Registration: ClinicalTrials.Gov Protocol Registration and Results System (NCT04478058); clinicaltrials.gov/ct2/show/NCT04478058.

6.
PLoS One ; 18(5): e0285757, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37192176

RESUMO

BACKGROUND: Insomnia is one of the most prevalent sleep disorders characterized by an inability to fall or stay asleep. Available treatments include pharmacotherapy and cognitive behavioural therapy for insomnia (CBTi). Although CBTi is the first-line treatment, it has limited availability. Therapist-guided electronic delivery of CBT for insomnia (e-CBTi) offers scalable solutions to enhance access to CBTi. While e-CBTi produces comparable outcomes to in-person CBTi, there is a lack of comparison to active pharmacotherapies. Therefore, direct comparisons between e-CBTi and trazodone, one of the most frequently prescribed medications for insomnia, is essential in establishing the effectiveness of this novel digital therapy in the health care system. OBJECTIVE: The aim of this study is to compare the effectiveness of a therapist-guided electronically-delivered cognitive behavioural therapy (e-CBTi) program to trazodone in patients with insomnia. METHODS: Patients (n = 60) will be randomly assigned to two groups: treatment as usual (TAU) + trazodone and TAU + e-CBTi for seven weeks. Each weekly sleep module will be delivered through the Online Psychotherapy Tool (OPTT), a secure, online mental health care delivery platform. Changes in insomnia symptoms will be evaluated throughout the study using clinically validated symptomatology questionnaires, Fitbits, and other behavioural variables. RESULTS: Participant recruitment began in November 2021. To date, 18 participants have been recruited. Data collection is expected to conclude by December 2022 and analyses are expected to be completed by January 2023. CONCLUSIONS: This comparative study will improve our understanding of the efficacy of therapist-guided e-CBTi in managing insomnia. These findings can be used to develop more accessible and effective treatment options and influence clinical practices for insomnia to further expand mental health care capacity in this population. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05125146).


Assuntos
Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Trazodona , Humanos , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Preparações Farmacêuticas , Trazodona/uso terapêutico , Terapia Cognitivo-Comportamental/métodos , Resultado do Tratamento , Inquéritos e Questionários , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Front Psychiatry ; 14: 1220607, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38188047

RESUMO

Introduction: Depression is a leading cause of disability worldwide, affecting up to 300 million people globally. Despite its high prevalence and debilitating effects, only one-third of patients newly diagnosed with depression initiate treatment. Electronic cognitive behavioural therapy (e-CBT) is an effective treatment for depression and is a feasible solution to make mental health care more accessible. Due to its online format, e-CBT can be combined with variable therapist engagement to address different care needs. Typically, a multi-professional care team determines which combination therapy most benefits the patient. However, this process can add to the costs of these programs. Artificial intelligence (AI) has been proposed to offset these costs. Methods: This study is a double-blinded randomized controlled trial recruiting individuals experiencing depression. The degree of care intensity a participant will receive will be randomly decided by either: (1) a machine learning algorithm, or (2) an assessment made by a group of healthcare professionals. Subsequently, participants will receive depression-specific e-CBT treatment through the secure online platform. There will be three available intensities of therapist interaction: (1) e-CBT; (2) e-CBT with a 15-20-min phone/video call; and (3) e-CBT with pharmacotherapy. This approach aims to accurately allocate care tailored to each patient's needs, allowing for more efficient use of resources. Discussion: Artificial intelligence and providing patients with varying intensities of care can increase the efficiency of mental health care services. This study aims to determine a cost-effective method to decrease depressive symptoms and increase treatment adherence to online psychotherapy by allocating the correct intensity of therapist care for individuals diagnosed with depression. This will be done by comparing a decision-making machine learning algorithm to a multi-professional care team. This approach aims to accurately allocate care tailored to each patient's needs, allowing for more efficient use of resources with the convergence of technologies and healthcare. Ethics: The study received ethics approval and began participant recruitment in December 2022. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2024. Clinical trial registration: ClinicalTrials.Gov, identifier NCT04747873.

8.
Front Psychiatry ; 13: 1004143, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36386978

RESUMO

Purpose: Correctional work is described as a high-stress environment associated with increased prevalence of mental health disorders in employees. Identifying appropriate healthcare services necessitates investigating the mental health challenges and needs of correctional workers (CWs). Methods: Individual interviews (n = 9; 5 M and 4 W) and a mixed gender focus group (n = 6; 3 M and 3 W) were conducted to gather a general sense of the mental health landscape. Data were analyzed to develop a targeted and comprehensive question guide for gender-specific focus groups (n = 14 unique participants; 6 M and 8 W). Results: Eight themes emerged from the gender-specific focus groups. Themes focusing on work culture described the negative repercussions of job stress and the inability to discuss challenges openly due to confidentiality concerns and feelings of seclusion associated with the CW profession. Men were more likely to be subjected to physical violence and women to emotional and sexual harassment from staff and inmates. Themes related to mental health care described the benefits and limitations of the current services and digital mental healthcare. Stigma and accessibility were notable treatment barriers. Lastly, sector-specific therapy was seen as an important component in enhancing engagement and therapist interaction. Conclusion: The study demonstrates the interconnection between work culture and CW mental health that needs to be acknowledged when addressing mental health care.

9.
JMIR Res Protoc ; 10(7): e30845, 2021 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-34088656

RESUMO

BACKGROUND: Public safety personnel have regular and often intense exposure to potentially traumatic events at work, especially workplace violence in the case of correctional workers. Subsequently, correctional workers are at higher risk of developing mental health problems such as posttraumatic stress disorder. Public safety personnel are up to 4 times more likely to experience suicidal ideation, suicidal attempts, and death by suicide compared to the general population. Despite this high prevalence, help-seeking behaviors from public safety personnel are low due to stigma and irregular work hours limiting access to care. Innovative treatments are needed to address these challenges. OBJECTIVE: This study will investigate the efficacy of an electronically delivered cognitive behavioral therapy (e-CBT) program tailored to correctional workers' mental health problems. METHODS: This study is composed of 4 phases. In phase 1, we will interview correctional workers individually and in focus groups to identify personal, social, and cultural factors affecting their mental health and barriers to care. Phase 2 will use the information gathered from the interviews to develop gender- and diagnosis-specific e-CBT modules. These will be presented to a new group of participants who will provide further feedback on their usability and accessibility. In phase 3, we will randomly assign participants to either an e-CBT or treatment as usual arm. The program will be evaluated with validated symptomatology questionnaires and interviews. Phase 4 will use this additional information to fine-tune the e-CBT modules for a larger-scale randomized controlled trial design comparing the e-CBT program to in-person CBT. All e-CBT modules will be delivered through a secure online platform. RESULTS: The study received ethics approval in December 2020, and participant recruitment began in March 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. To date, there have been 15 participants recruited for Phase 1, and it is expected to conclude in July 2021, with phase 2 beginning in September 2021. Complete data collection and analysis from all phases are expected to conclude by July 2023. Linear and binomial regression (for continuous and categorical outcomes, respectively) will be conducted along with interpretive qualitative methods. CONCLUSIONS: If proven efficacious and feasible, this e-CBT program can provide a high-quality and clinically validated resource to address the mental health problems of correctional workers. Additionally, findings can contribute to the development of innovative treatments for other public safety professions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04666974; https://www.clinicaltrials.gov/ct2/show/NCT04666974. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30845.

10.
JMIR Res Protoc ; 10(6): e27489, 2021 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-33990076

RESUMO

BACKGROUND: Major depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers. OBJECTIVE: This study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement. METHODS: This nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. RESULTS: Ethics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted. CONCLUSIONS: The results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27489.

11.
JMIR Res Protoc ; 10(5): e27772, 2021 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-33857917

RESUMO

BACKGROUND: Generalized anxiety disorder (GAD) is an extremely prevalent and debilitating mental health disorder. Currently, the gold standard treatment for GAD is cognitive behavioral therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. While CBT is the gold standard treatment for GAD, it is costly, time-consuming, and often inaccessible. Fortunately, the electronic delivery of CBT (e-CBT) has emerged as a promising solution to address these barriers. e-CBT has shown to offer comparable results to in-person CBT while improving accessibility for patients and time efficiency for clinicians. OBJECTIVE: This study aims to investigate the treatment efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD. METHODS: This study will use a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to receive. Participants with a diagnosis of GAD will be enrolled in 1 of 3 possible treatment arms: (1) e-CBT, (2) medication, or (3) a combination of e-CBT and medication. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool-a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared with that of medication alone and medication in combination with e-CBT. RESULTS: The study received ethics approval in April 2019 and participant recruitment began in June 2019. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 146 participants (e-CBT: n=53; medication: n=49; combination: n=44) have been recruited. Data collection is expected to conclude by June 2021, and data analysis is expected to be completed by October 2021. Linear regression (for continuous outcomes) and binomial regression (for categorical outcomes) analysis will be conducted using interpretive qualitative methods. CONCLUSIONS: If either the efficacy of e-CBT is shown to be comparable to that of medication or the effects of both treatments are augmented when used in tandem, these findings could have major implications on the mental health care system. e-CBT is a more accessible and affordable treatment that could increase mental health care capacity 4-fold if proven viable. TRIAL REGISTRATION: ClinicalTrials.gov NCT04478526; https://clinicaltrials.gov/ct2/show/NCT04478526. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27772.

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