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BACKGROUND Generalized anxiety disorder (GAD) is a prevalent anxiety disorder with cognitive behavioural 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. Online interventions for mental health disorders are an innovative and promising way to address these barriers. While the electronic delivery of CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on one's 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 online delivery of this intervention. OBJECTIVE This study will compare the efficacy of e-CBT and a virtual mental health check-in program to treat GAD. These programs will both be delivered through a secure, online, care delivery platform. METHODS Participants (n = 100) over 18 years with a confirmed diagnosis of GAD will be randomly allocated 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 pre-designed 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 online platform’s written chat feature (messaging system). 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 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, week 12, and at a 6-month follow-up. 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 2022. 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 an online 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. CLINICALTRIAL clinicaltrials.gov (NCT04754438)

BACKGROUND Law enforcement officers are routinely exposed to hazardous, disturbing events that can impose severe stress and long-term psychological trauma. As a result, police and other public safety personnel (PSP) are at increased risk of developing posttraumatic stress injuries (PTSIs) and disruptions to the autonomic nervous system (ANS). ANS functioning can be objectively and noninvasively measured by heart rate (HR), heart rate variability (HRV), and respiratory sinus arrhythmia (RSA). Traditional interventions aimed at building resilience among PSP have not adequately addressed the physiological ANS dysregulations that lead to mental and physical health conditions, as well as burnout and fatigue following potential psychological trauma. OBJECTIVE In this study, we will investigate the efficacy of a web-based Autonomic Modulation Training (AMT) intervention on the following outcomes: (1) reducing self-reported symptoms of PTSI, (2) strengthening ANS physiological resilience and wellness capacity, and (3) exploring how sex and gender are related to baseline differences in psychological and biological PTSI symptoms and response to the AMT intervention. METHODS The study is comprised of 2 phases. Phase 1 involves the development of the web-based AMT intervention, which includes 1 session of baseline survey measures, 6 weekly sessions that integrate HRV biofeedback (HRVBF) training with meta-cognitive skill practice, and 1 session of follow-up survey measures. Phase 2 will use a cluster randomized control design to test the effectiveness of AMT on the following prepost outcomes: (1) self-report symptoms of PTSI and other wellness measures; (2) physiological indicators of health and resilience including resting HR, HRV, and RSA; and (3) the influence of sex and gender on other outcomes. Participants will be recruited for an 8-week study across Canada in rolling cohorts. RESULTS The study received grant funding in March 2020 and ethics approval in February 2021. Due to delays related to COVID-19, phase 1 was completed in December 2022, and phase 2 pilot testing began in February 2023. Cohorts of 10 participants in the experimental (AMT) and control (prepost assessment only) groups will continue until a total of 250 participants are tested. Data collection from all phases is expected to conclude in December 2025 but may be extended until the intended sample size is reached. Quantitative analyses of psychological and physiological data will be conducted in conjunction with expert coinvestigators. CONCLUSIONS There is an urgent need to provide police and PSP with effective training that improves physical and psychological functioning. Given that help-seeking for PTSI is reduced among these occupational groups, AMT is a promising intervention that can be completed in the privacy of one’s home. Importantly, AMT is a novel program that uniquely addresses the underlying physiological mechanisms that support resilience and wellness promotion and is tailored to the occupational demands of PSP. CLINICALTRIAL ClinicalTrials.gov NCT05521360; https://clinicaltrials.gov/ct2/show/NCT05521360 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/33492

BACKGROUND Bipolar disorder (BD) is a highly prevalent psychiatric condition that can significantly impact every aspect of a person’s life if left untreated. A subtype of BD, bipolar disorder type II (BD-II), is characterized by long depressive episodes and residual depression symptoms, with short-lived hypomanic episodes. Medication and psychotherapy, such as cognitive behavioral therapy (CBT), are the main treatment options for BD-II. CBT specific for BD-II involves the recognition of warning signs, potentially triggering stimuli, and the development of coping skills to increase euthymic periods and improve global functioning. However, access to in-person CBT may be limited by several barriers, including low availability, high costs, and geographical limitations. Thus, web-based adaptations of CBT (e-CBT) have become a promising solution to address these treatment barriers. Nevertheless, e-CBT for the treatment of BD-II remains understudied. OBJECTIVE The proposed study aims to establish the first e-CBT program specific for the treatment of BD-II with residual depressive symptoms. The primary objective of this study will be to determine the effect of e-CBT in managing BD symptomatology. The secondary objective will be to assess the effects of this e-CBT program on quality of life and resilience. The tertiary objective will involve gathering user feedback using a posttreatment survey to support the continuous improvement and optimization of the proposed program. METHODS Adult participants (N=170) with a confirmed diagnosis of BD-II experiencing residual depressive symptoms will be randomly assigned to either the e-CBT and treatment as usual (TAU; n=85) group or the TAU (n=85) control group. Participants in the control group will be able to participate in the web-based program after the first 13 weeks. The e-CBT program will consist of 13 weekly web-based modules designed following a validated CBT framework. Participants will complete module-related homework and receive asynchronous personalized feedback from a therapist. TAU will consist of standard treatment services conducted outside of this research study. Depression and manic symptoms, quality of life, and resiliency will be assessed using clinically validated symptomatology questionnaires at baseline, week 6, and week 13. RESULTS The study received ethics approval in March 2020, and participant recruitment is expected to begin in February 2023 through targeted advertisements and physician referrals. Data collection and analysis are expected to conclude by December 2024. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted along with qualitative interpretive methods. CONCLUSIONS The findings will be the first on the effectiveness of delivering e-CBT for patients with BD-II with residual depressive symptoms. This approach can provide an innovative method to address barriers to in-person psychotherapy by increasing accessibility and decreasing costs. CLINICALTRIAL ClinicalTrials.gov NCT04664257; https://clinicaltrials.gov/ct2/show/NCT04664257 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/46157

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

BACKGROUND Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically significant distress. Patients with AUD frequently experience high relapse rates and only one in five remain abstinent 12 months post-treatment. Traditional face-to-face relapse prevention treatment (RPT) is a form of cognitive behavioural therapy 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. An online 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 at 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 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 ten 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, mid-treatment, and 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 (continuous and categorical outcomes respectively). Qualitative data will be analyzed using thematic analysis methods. CONCLUSIONS The current study will be the first to examine the effectiveness of e-RPT compared to face-to-face RPT. It is posited that online care can present benefits in terms of accessibility and affordability compared to traditional face-to-face psychotherapy. CLINICALTRIAL clinicaltrials.gov (NCT05579210)

Background Obsessive-compulsive disorder (OCD) is a debilitating and prevalent anxiety disorder. Although the basal ganglia and frontal cortex are the brain regions that are most commonly hypothesized to be involved in OCD, the exact pathophysiology is unknown. By observing the effects of proven treatments on brain activation levels, the cause of OCD can be better understood. Currently, the gold standard treatment for OCD is cognitive behavioral therapy (CBT) with exposure and response prevention. However, this is often temporally and geographically inaccessible, time consuming, and costly. Fortunately, CBT can be effectively delivered using the internet (electronically delivered CBT [e-CBT]) because of its structured nature, thus addressing these barriers. Objective The aims of this study are to implement an e-CBT program for OCD and to observe its effects on brain activation levels using functional magnetic resonance imaging (MRI). It is hypothesized that brain activation levels in the basal ganglia and frontal cortex will decrease after treatment. Methods Individuals with OCD will be offered a 16-week e-CBT program with exposure and response prevention mirroring in-person CBT content and administered through a secure web-based platform. The efficacy of the treatment will be evaluated using clinically validated symptomology questionnaires at baseline, at week 8, and after treatment (week 16). Using functional MRI at baseline and after treatment, brain activation levels will be assessed in the resting state and while exposed to anxiety-inducing images (eg, dirty dishes if cleanliness is an obsession). The effects of treatment on brain activation levels and the correlation between symptom changes and activation levels will be analyzed. Results The study received initial ethics approval in December 2020, and participant recruitment began in January 2021. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 5 participants have been recruited. Data collection is expected to conclude by January 2022, and data analysis is expected to be completed by February 2022. Conclusions The findings from this study can further our understanding of the causation of OCD and help develop more effective treatments for this disorder. Trial Registration ClinicalTrials.gov NCT04630197; https://clinicaltrials.gov/ct2/show/NCT04630197. International Registered Report Identifier (IRRID) PRR1-10.2196/30726

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

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 for developing mental health problems such as posttraumatic stress disorder. Public safety personnel are up to 4 times more likely to experience suicidal ideation, attempts, and death by suicide compared to the general population. Despite this high prevalence, help-seeking behaviours 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 behavioural therapy (e-CBT) program tailored to correctional workers’ mental health problems. METHODS This study is composed of 4 phases. Phase 1 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. Phase 3 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 is expected to conclude by July 2023. Linear and binomial regression (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. CLINICALTRIAL ClinicalTrials.gov NCT04666974; clinicaltrials.gov/ct2/show/NCT04666974

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. CLINICALTRIAL ClinicalTrials.gov NCT04664270; https://clinicaltrials.gov/ct2/show/NCT04664270 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30735

BACKGROUND Obsessive-compulsive disorder (OCD) is a debilitating and prevalent anxiety disorder. Although the basal ganglia and frontal cortex are the brain regions that are most commonly hypothesized to be involved in OCD, the exact pathophysiology is unknown. By observing the effects of proven treatments on brain activation levels, the cause of OCD can be better understood. Currently, the gold standard treatment for OCD is cognitive behavioral therapy (CBT) with exposure and response prevention. However, this is often temporally and geographically inaccessible, time consuming, and costly. Fortunately, CBT can be effectively delivered using the internet (electronically delivered CBT [e-CBT]) because of its structured nature, thus addressing these barriers. OBJECTIVE The aims of this study are to implement an e-CBT program for OCD and to observe its effects on brain activation levels using functional magnetic resonance imaging (MRI). It is hypothesized that brain activation levels in the basal ganglia and frontal cortex will decrease after treatment. METHODS Individuals with OCD will be offered a 16-week e-CBT program with exposure and response prevention mirroring in-person CBT content and administered through a secure web-based platform. The efficacy of the treatment will be evaluated using clinically validated symptomology questionnaires at baseline, at week 8, and after treatment (week 16). Using functional MRI at baseline and after treatment, brain activation levels will be assessed in the resting state and while exposed to anxiety-inducing images (eg, dirty dishes if cleanliness is an obsession). The effects of treatment on brain activation levels and the correlation between symptom changes and activation levels will be analyzed. RESULTS The study received initial ethics approval in December 2020, and participant recruitment began in January 2021. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 5 participants have been recruited. Data collection is expected to conclude by January 2022, and data analysis is expected to be completed by February 2022. CONCLUSIONS The findings from this study can further our understanding of the causation of OCD and help develop more effective treatments for this disorder. CLINICALTRIAL ClinicalTrials.gov NCT04630197; https://clinicaltrials.gov/ct2/show/NCT04630197. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/30726

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

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. CLINICALTRIAL ClinicalTrials.gov NCT04771767; https://clinicaltrials.gov/ct2/show/NCT04771767. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/30334

Cardiovascular disease is the leading global cause of mortality, with ischemic heart disease causing the majority of cardiovascular deaths. Despite this, diagnostic delay commonly occurs in women experiencing acute myocardial infarction (AMI) who have a higher associated in-hospital mortality. Several studies have demonstrated that women are significantly more likely than men to experience depression and anxiety following AMI which is linked with increased morbidity, rehospitalization, and mortality, as well as decreased quality of life. Thus, it is imperative that future work aims to understand the factors that put women at higher risk for depression and anxiety following AMI, informing prevention and intervention. This narrative review will summarize the current literature on the association between AMI and mental health in women, including the impact on morbidity, mortality, and quality of life.

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. CLINICALTRIAL ClinicalTrials.gov NCT04478526; https://clinicaltrials.gov/ct2/show/NCT04478526 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27772

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. CLINICALTRIAL ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27489

BACKGROUND Borderline personality disorder is a debilitating and prevalent mental health disorder, with often inaccessible treatment options. Electronically delivered dialectical behavioral therapy could be an efficacious and more accessible intervention. OBJECTIVE We aimed to evaluate the efficacy of electronic delivery of dialectical behavioral therapy in the treatment of individuals with symptoms of borderline personality disorder. METHODS Study participants diagnosed with borderline personality disorder were offered either an email-based or in-person group format dialectical behavioral therapy skill-building program. During each session, participants were provided with both the material and feedback regarding their previous week’s homework. Electronically delivered dialectical behavioral therapy protocol and content were designed to mirror in-person content. Participants were assessed using the Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale (DERS). RESULTS There were significant increases in SAQ scores from pre- to posttreatment in the electronic delivery group (F1,92=69.32, PF1,92=60.97, PF1,92=.05, P=.83). There were significant decreases in DERS scores observed between pre- and posttreatment in the electronic delivery group (F1,91=30.15, PF1,91=58.18, PF1,91=.24, P=.63). There was no significant difference in treatment efficacy observed between the 2 treatment arms (P CONCLUSIONS Despite the proven efficacy of in-person dialectical behavioral therapy in the treatment of borderline personality disorder, there are barriers to receiving this treatment. With the prevalence of internet access continuing to rise globally, delivering dialectical behavioral therapy with email may provide a more accessible alternative to treatment for individuals with borderline personality disorder without sacrificing the quality of care. CLINICALTRIAL ClinicalTrials.gov NCT04493580; https://clinicaltrials.gov/ct2/show/NCT04493580

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

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. CLINICALTRIAL ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/ct2/show/NCT04476667 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24913

Background: Vitamin D deficiency and infertility are two important health problems in Iran. Some studies suggest that vitamin D may influence Anti-Müllerian hormone (AMH) and antral follicle count (AFC) as an ovarian reserve.Objective: The present study aimed to investigate the impact of vitamin D on AMH serum concentrations/AFC.Materials and Methods: Three hundred and five infertile women referred to the IVF Unit of Yas hospital, between July and December 2017, were enrolled in this cross-sectional study. The demographic characteristics of the participants, as well as the serum levels of vitamin D, AMH, and ultrasonic examination of AFC were recorded.Results: Finally, 287 infertile women were included in the analysis with a mean age of 29.95 ± 4.73 yr (18-45 yr) and a mean Body mass indexof 25.11 ± 4.41 kg/m 2 . The median AMH and vitamin D levels were 3.20 and 22.82 ng/ml, respectively. Considering the cut-off level of 20 ng/ml, 58.7% were vitamin D deficient. Regression analysis showed no association between AMH and vitamin D levels (p = 0.161), even after adjusting for baseline variables (p = 0.182). A total of 120 patients had an AFC < 6 and 164 ≥ 6, which was not statistically different between the groups with normal level or deficient vitamin D (p = 0.133).Conclusion: The present cross-sectional study showed no significant association between serum levels of vitamin D and AMH or AFC in infertile women, even after adjusting for baseline variables.

OBJECTIVE A lack of resources and cultural stigma associated with mental health treatment necessitate the development of innovative and economical individualized treatments. This study evaluated the efficacy of delivering computer-based cognitive behavioral therapy (e-CBT) presented through Microsoft PowerPoint and delivered via email in the treatment of generalized anxiety disorder (GAD) to Iranian patients, as a means of overcoming treatment barriers. METHODS Participants (N=80) of Iranian descent were recruited through announcements on psychology websites, Iranian organization websites, weblogs, and in flyers. Participants were randomly assigned to either an e-CBT or a control group. The e-CBT group received 12 weekly modules and homework assignments through email, presented using PowerPoint. The control group received no treatment (individuals in the control group were able to pursue another treatment, but would then be excluded from the study although they could continue with the program). All emails were sent by an attending or resident psychiatrist, who also provided feedback on weekly homework via email. The Beck Anxiety Inventory was used to measure levels of anxiety before study onset and changes in levels of anxiety upon completion of the program at 12 weeks, and at 6-month and 1-year follow-up in both groups. RESULTS Beck Anxiety Inventory scores were significantly reduced in the group who received PowerPoint e-CBT modules delivered via email, compared with the control group, following 12 weeks of treatment, and the reductions were maintained at both follow-up points. CONCLUSIONS Delivery of PowerPoint e-CBT modules via email was found to be a viable method for delivering CBT to individuals with GAD and a simple method for overcoming language, cultural, and travel barriers to accessing mental health resources. This simplified approach to the individualization and delivery of treatment modules has the potential to improve access to CBT as a treatment option throughout the world.

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

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

Objective Although risk assessment for suicide has been extensively studied, it is still an inexact process. The current study determined how busy emergency clinicians actually assessed and documented suicide risk, while also examining the differences between psychiatric and emergency medicine opinions on the importance of various suicide predictors. Method Phase 1 of the study involved the administration of a survey on the relative importance of various suicide predictors for the specialties of psychiatry and emergency medicine. In phase 2 of the study, a chart review of psychiatric emergency room patients was conducted to determine the actual documentation rates of the suicide predictors. Results Several predictors that were deemed to be important, including suicidal plan, intent for suicide, having means available for suicide, and practicing suicide (taking different steps leading up to suicide but not actually attempting suicide), had low documentation rates. Conclusions Medical specialties have different opinions on the importance of various suicide predictors. Also, some predictors deemed important had low documentation rates. Educational interventions and simple assessment tools may help to increase documentation rates of several suicide predictors in busy clinical settings.