Experiences using an online therapist-guided psychotherapy platform (OPTT) in correctional workers with depression, anxiety, and PTSD.

Introduction: Correctional workers (CWs) are frequently exposed to potentially traumatic events in the workplace, leading to an increased prevalence of mental health concerns. Online psychotherapy can address many of the barriers CWs face when seeking adequate mental health care. Despite their benefits, CWs' experience using digital mental health interventions is relatively unknown. This information could be valuable in developing enhanced care delivery to improve recruitment, retention, satisfaction, and treatment outcomes. Methods: This study investigated the experiences of a sample of CWs enrolled in a clinical trial evaluating the efficacy of the Online Psychotherapy Tool (OPTT) in this population. Participants were surveyed and interviewed to capture their opinions and feedback on the program. Survey analysis was conducted through Qualtrics statistical analysis software. The interview transcripts and open-ended survey questions were analyzed using thematic analysis methods in NVivo. Results: Participants (n=14) were cis-gender, predominantly white, with an average age of 38 years. While most respondents preferred in-person therapy, they also reported the benefits of the online psychotherapy program. Specifically, they expressed positive perceptions of the platform, the quality and interaction of their care provider, and the homework assignments and skills learned. Lack of motivation to complete weekly homework assignments was a frequently cited challenge. Unhelpful aspects of the therapy noted issues with the online format and frustration with certain program elements. Discussion: Participants expressed a positive outlook on the program, the platform, and treatment outcomes. A preference for in-person therapy was still indicated, demonstrating the need to focus on engagement in digital mental health interventions. In addition, the findings of this study shed light on the factors that can influence help-seeking in this population, including stigma in the work environment, demanding work schedules, workplace perceptions, and previous experiences accessing mental health services.

Incorporating a Stepped Care Approach Into Internet-Based Cognitive Behavioral Therapy for Depression: Randomized Controlled Trial.

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.

Comparing the efficacy of electronic cognitive behavioral therapy to medication and combination therapy for generalized anxiety disorder: a quasi-experimental clinical trial.

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.

Efficacy of an Electronic Cognitive Behavioral Therapy Program Delivered via the Online Psychotherapy Tool for Depression and Anxiety Related to the COVID-19 Pandemic: Pre-Post Pilot Study.

BACKGROUND: Lockdowns and social distancing resulting from the COVID-19 pandemic have worsened the population's mental health and made it more difficult for individuals to receive care. Electronic cognitive behavioral therapy (e-CBT) is a cost-effective and evidence-based treatment for anxiety and depression and can be accessed remotely. OBJECTIVE: The objective of the study was to investigate the efficacy of online psychotherapy tailored to depression and anxiety symptoms during the pandemic. METHODS: The pilot study used a pre-post design to evaluate the efficacy of a 9-week e-CBT program designed for individuals with depression and anxiety affected by the pandemic. Participants were adults (N=59) diagnosed with major depressive disorder and generalized anxiety disorder, whose mental health symptoms initiated or worsened during the COVID-19 pandemic. The online psychotherapy program focused on teaching coping, mindfulness, and problem-solving skills. Symptoms of anxiety and depression, resilience, and quality of life were assessed. RESULTS: Participants demonstrated significant improvements in symptoms of anxiety (P=.02) and depression (P=.03) after the intervention. Similar trends were observed in the intention-to-treat analysis. No significant differences were observed in resilience and quality-of-life measures. The sample comprised mostly females, making it challenging to discern the benefits of the intervention in males. Although a pre-post design is less rigorous than a controlled trial, this design was selected to observe changes in scores during a critical period. CONCLUSIONS: e-CBT for COVID-19 is an effective and accessible treatment option. Improvements in clinical symptoms of anxiety and depression can be observed in individuals whose mental health is affected by the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/study/NCT04476667. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/24913.

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, 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.

User experiences of an online therapist-guided psychotherapy platform, OPTT: A cross-sectional study.

Introduction: In the last few years, online psychotherapy programs have burgeoned since they are a more accessible and scalable treatment option compared to in-person therapies. While these online programs are promising, understanding the user experience and perceptions of care is essential for program optimization. Methods: This study investigated the experiences of end-users who had previously received online psychotherapy through a web-based platform. A 35-item multiple-choice survey was developed by the research team and distributed to past users to capture their perceptions of the program. Results: The survey yielded 163 responses, with a 90 % completion rate. Participants were predominantly white and female, with an average age of 42 years. While most participants preferred in-person therapy, they also reported the benefits of the online psychotherapy program. Participants had positive perceptions of the platform, the quality and interaction of their therapist, and the homework assignments and skills covered. Lack of motivation to complete weekly homework assignments was cited as a common struggle. Discussion: The findings support online psychotherapy as a beneficial digital mental health tool and highlight some areas for improvement. Scalability and accessibility are key benefits of the platform. At the same time, improvements in participant engagement, including those from equity-seeking and equity-deserving groups, may enhance the efficacy of the programs offered.

Comparison of online and in-person cognitive behavioral therapy in individuals diagnosed with major depressive disorder: a non-randomized controlled trial.

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.

Investigating the effectiveness of electronically delivered cognitive behavioural therapy (e-CBTi) compared to pharmaceutical interventions in treating insomnia: Protocol for a randomized controlled trial.

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).

Mental health challenges, treatment experiences, and care needs of post-secondary students: a cross-sectional mixed-methods study.

BACKGROUND: Post-secondary students frequently experience high rates of mental health challenges. However, they present meagre rates of treatment-seeking behaviours. This elevated prevalence of mental health problems, particularly after the COVID-19 pandemic, can lead to distress, poor academic performance, and lower job prospects following the completion of education. To address the needs of this population, it is important to understand students' perceptions of mental health and the barriers preventing or limiting their access to care. METHODS: A broad-scoping online survey was publicly distributed to post-secondary students, collecting demographic, sociocultural, economic, and educational information while assessing various components of mental health. RESULTS: In total, 448 students across post-secondary institutions in Ontario, Canada, responded to the survey. Over a third (n = 170; 38.6%) of respondents reported a formal mental health diagnosis. Depression and generalized anxiety disorder were the most commonly reported diagnoses. Most respondents felt that post-secondary students did not have good mental health (n = 253; 60.5%) and had inadequate coping strategies (n = 261; 62.4%). The most frequently reported barriers to care were financial (n = 214; 50.5%), long wait times (n = 202; 47.6%), insufficient resources (n = 165; 38.9%), time constraints (n = 148; 34.9%), stigma (n = 133; 31.4%), cultural barriers (n = 108; 25.5%), and past negative experiences with mental health care (n = 86; 20.3%). The majority of students felt their post-secondary institution needed to increase awareness (n = 231; 56.5%) and mental health resources (n = 306; 73.2%). Most viewed in-person therapy and online care with a therapist as more helpful than self-guided online care. However, there was uncertainty about the helpfulness and accessibility of different forms of treatment, including online interventions. The qualitative findings highlighted the need for personal strategies, mental health education and awareness, and institutional support and services. CONCLUSIONS: Various barriers to care, perceived lack of resources, and low knowledge of available interventions may contribute to compromised mental health in post-secondary students. The survey findings indicate that upstream approaches such as integrating mental health education for students may address the varying needs of this critical population. Therapist-involved online mental health interventions may be a promising solution to address accessibility issues.

Developing and Implementing a Web-Based Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND:  Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically substantial distress. Patients with AUD frequently experience high relapse rates, and only 1 in 5 remain abstinent 12 months post treatment. Traditional face-to-face relapse prevention therapy (RPT) is a form of cognitive behavioral therapy (CBT) that examines one's situational triggers, maladaptive thought processes, self-efficacy, and motivation. However, access to this treatment is frequently limited due to its high cost, long waitlists, and inaccessibility. A web-based adaptation of RPT (e-RPT) could address these limitations by providing a more cost-effective and accessible delivery method for mental health care in this population. OBJECTIVE:  This study protocol aims to establish the first academic e-RPT program to address AUD in the general population. The primary objective of this study is to compare the efficacy of e-RPT to face-to-face RPT in decreasing relapse rates. The secondary objective is to assess the effects of e-RPT on quality of life, self-efficacy, resilience, and depressive symptomatology. The tertiary objective is to evaluate the cost-effectiveness of e-RPT compared to face-to-face RPT. METHODS:  Adult participants (n=60) with a confirmed diagnosis of AUD will be randomly assigned to receive 10 sessions of e-RPT or face-to-face RPT. e-RPT will consist of 10 predesigned modules and homework with asynchronous, personalized feedback from a therapist. Face-to-face RPT will comprise 10 one-hour face-to-face sessions with a therapist. The predesigned modules and the face-to-face sessions will present the same content and structure. Self-efficacy, resilience, depressive symptomatology, and alcohol consumption will be measured through various questionnaires at baseline, amid treatment, and at the end of treatment. RESULTS:  Participant recruitment is expected to begin in October 2022 through targeted advertisements and physician referrals. Completed data collection and analysis are expected to conclude by October 2023. Outcome data will be assessed using linear and binomial regression (for continuous and categorical outcomes, respectively). Qualitative data will be analyzed using thematic analysis methods. CONCLUSIONS:  This study will be the first to examine the effectiveness of e-RPT compared to face-to-face RPT. It is posited that web-based care can present benefits in terms of accessibility and affordability compared to traditional face-to-face psychotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05579210; https://clinicaltrials.gov/ct2/show/NCT05579210. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44694.

Comparing clinical decision-making of AI technology to a multi-professional care team in an electronic cognitive behavioural therapy program for depression: protocol.

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.

Developing and Implementing a Web-Based Psychotherapy Program to Address Mental Health Challenges Among Patients Receiving Oncologic and Palliative Care: Protocol for an Open-Label Randomized Controlled Trial.

BACKGROUND: The demand for mental health care, particularly for depression and anxiety, is 3-fold greater among patients receiving oncologic and palliative care than for the general population. This population faces unique barriers, making them more susceptible to mental health challenges. Various forms of psychotherapy have been deemed effective in addressing mental health challenges in this population, including supportive psychotherapy, cognitive behavioral therapy, problem-based therapy, and mindfulness; however, their access to traditional face-to-face psychotherapy resources is limited owing to their immunocompromised status, making frequent hospital visits dangerous. Additionally, patients can face hospital fatigue from numerous appointments and investigations or may live in remote areas, which makes commutes both physically and financially challenging. Web-based psychotherapy is a promising solution to address these accessibility barriers. Moreover, web-based psychotherapy has been proven effective in addressing depression and anxiety in other populations and may be implementable among patients receiving oncologic and palliative care. OBJECTIVE: The study will investigate the feasibility and effectiveness of web-based psychotherapy among patients receiving oncologic and palliative care, who have comorbid depression or anxiety. We hypothesized that this program will be a viable and efficacious treatment modality compared to current treatment modalities in addressing depression and anxiety symptoms in this population. METHODS: Participants (n=60) with depression or anxiety will be recruited from oncology and palliative care settings in Kingston (Ontario, Canada). Participants will be randomly allocated to receive either 8 weeks of web-based psychotherapy plus treatment as usual (treatment arm) or treatment as usual exclusively (control arm). The web-based psychotherapy program will incorporate cognitive behavioral therapy, mindfulness, and problem-solving skills, and homework assignments with personalized feedback from a therapist. All web-based programs will be delivered through a secure platform specifically designed for web-based psychotherapy delivery. To evaluate treatment efficacy, all participants will complete standardized symptomology questionnaires at baseline, midpoint (week 4), and posttreatment. RESULTS: The study received ethics approval in February 2021 and began recruiting participants in April 2021. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 11 participants (treatment, n=5; control, n=4; dropout, n=2) have been recruited. Data collection and analysis are expected to conclude by December 2021 and January 2022, respectively. Linear regression (for continuous outcomes) will be conducted with interpretive qualitative methods. CONCLUSIONS: Our findings can be incorporated into clinical policy and help develop more accessible mental health treatment options for patients receiving oncologic and palliative care. Asynchronous and web-based psychotherapy delivery is a more accessible, scalable, and financially feasible treatment that could have major implications on the health care system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04664270; https://clinicaltrials.gov/ct2/show/NCT04664270. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30735.

Delivering an Online Cognitive Behavioral Therapy Program to Address Mental Health Challenges Faced by Correctional Workers and Other Public Safety Personnel: Protocol for a Mixed Methods Study.

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.

Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND: Over one third of patients with posttraumatic stress disorder (PTSD) do not respond to current interventions. Ketamine presents a potential treatment option; however, its effects are temporary. Administering ketamine alongside psychotherapy is one potential means of prolonging its effects; however, only a few studies have investigated this treatment method to date, and none have tested ketamine with internet-based or electronically delivered cognitive behavioral therapy (e-CBT). OBJECTIVE: This open-label randomized controlled trial aims to assess the efficacy of a combined treatment method of subanesthetic intravenous ketamine and e-CBT for treating patients with PTSD. METHODS: In total, 20 patients with refractory PTSD recruited from a community clinic will be randomly assigned to either an experimental group (n=10), receiving a combination of ketamine and therapist-administered e-CBT over 14 weeks, or a waitlist control group (n=10), receiving the experimental treatment after 14 weeks. Both groups will be assessed for the symptoms of PTSD and comorbid disorders before treatment, at two midway points, and at the end of the experiment. RESULTS: PTSD symptoms of participants in the experimental group are expected to improve significantly more than those of participants in the waitlist control group (P=.05) with a large effect size (η2=0.14). CONCLUSIONS: This is the first study to assess the relationship between e-CBT and ketamine and their combined ability to treat refractory PTSD. If successful, this study will open web-based, asynchronous therapeutic options for patients with PTSD and will provide new insights into the functional role of glutamate in trauma-related disorders as well as in learning, memory, and fear extinction. TRIAL REGISTRATION: ClinicalTrials.gov NCT04771767; https://clinicaltrials.gov/ct2/show/NCT04771767. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30334.

Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial.

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.

Using the Online Psychotherapy Tool to Address Mental Health Problems in the Context of the COVID-19 Pandemic: Protocol for an Electronically Delivered Cognitive Behavioral Therapy Program.

BACKGROUND: The considerable rise of mental health challenges during the COVID-19 pandemic has had detrimental effects on the public health sector and economy. To meet the overwhelming and growing demand for mental health care, innovative approaches must be employed to significantly expand mental health care delivery capacity. Although it is not feasible to increase the number of mental health care providers or hours they work in the short term, improving their time efficiency may be a viable solution. Virtually and digitally delivering psychotherapy, which has been shown to be efficient and clinically effective, might be a good method for addressing this growing demand. OBJECTIVE: This research protocol aims to evaluate the feasibility and efficacy of using an online, digital, asynchronous care model to treat mental health issues that are started or aggravated by stressors associated with the COVID-19 pandemic. METHODS: This nonrandomized controlled trial intervention will be delivered through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week electronically delivered cognitive behavioral therapy program that is tailored to address mental health problems in the context of the COVID-19 pandemic. This program will involve weekly self-guided educational material that provides an overview of behavioral skills and weekly homework. Participants (N=80) will receive personalized feedback from and weekly interaction with a therapist throughout the course of the program. The efficacy of the program will be evaluated using clinically validated symptomology questionnaires, which are to be completed by participants at baseline, week 5, and posttreatment. Inclusion criteria includes the capacity to consent; a primary diagnosis of generalized anxiety disorder or major depressive disorder, with symptoms that started or worsened during the COVID-19 pandemic; the ability to speak and read English; and consistent and reliable access to the internet. Exclusion criteria includes active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. RESULTS: This study received funding in May 2020. Ethics approval was received in June 2020. The recruitment of participants began in June 2020. Participant recruitment is being conducted via social media, web-based communities, and physician referrals. To date, 58 participants have been recruited (intervention group: n=35; control group: n=23). Data collection is expected to conclude by the end of 2020. Analyses (ie, linear regression analysis for continuous outcomes and binomial regression analysis for categorical outcomes) are expected to be completed by February 2021. CONCLUSIONS: If proven feasible, this care delivery method could increase care capacity by up to fourfold. The findings from this study can potentially influence clinical practices and policies and increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/ct2/show/NCT04476667. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24913.