Comparing the Efficacy of Electronically Delivered Cognitive Behavioral Therapy (e-CBT) to Weekly Online Mental Health Check-Ins for Generalized Anxiety Disorder-A Randomized Controlled Trial: Comparaison de l'efficacité de la thérapie cognitivo-comportementale délivrée par voie électronique (e-TCC) aux contrôles hebdomadaires en ligne de santé mentale pour le trouble d'anxiété généralisée - un essai randomisé contrôlé.

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

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

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.

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).

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.

Benefits of Digital Mental Health Care Interventions for Correctional Workers and Other Public Safety Personnel: A Narrative Review.

Chronic exposure to stressors and potentially psychologically traumatic events contributes to the high prevalence of mental health disorders in correctional workers (CWs) and other public safety personnel (PSP). Digital mental health interventions are an accessible and scalable method of improving and maintaining the mental health of this population. The current review explores the benefits of digital mental health interventions for PSP-with a focus on CWs-and how these innovations can address the limitations in in-person mental health care. A systematic literature search of five databases (Medline, PsycInfo, Embase, CINAHL, Google Scholar) was conducted until March 2022. The search yielded 16 publications that focused on digital mental health interventions or care available to CWs and other PSP. The benefits of digital innovations were summarized into five categories which discussed (1) their ability to enhance accessibility and reduce stigma; (2) the provision of evidence-based and structured psychotherapy programs; (3) variability in the degree of therapist engagement; (4) the integration of proactive interventions; and (5) enhancing engagement by acknowledging unique experiences and interpersonal relationships. Although digital mental health technologies for CWs are still in their infancy, there is strong evidence to support their effectiveness in ameliorating symptoms of mental distress. Future research should consider how ethnicity, gender, culture, sexual orientation, and socioeconomic status can be integrated into these therapies and how the interplay between different stakeholders and organizations can impact the effectiveness of online therapies and programs.

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.

Comparison of efficacy and safety of two available natural surfactants in Iran, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome: A randomized clinical trial.

INTRODUCTION: The benefit of surfactant prescription for respiratory distress syndrome (RDS) has been approved. Curosurf and Survanta are two commonly used natural surfactants in Iran. Previous studies did not report priority for one of these two drugs. The present study aimed to compare the effectiveness and safety of Curosurf and Survanta in treatment of RDS. METHODS: In this randomized clinical trial, neonates were born with RDS diagnosis in two governmental and referral hospitals of Tehran (the capital of Iran) in 2014 were randomly selected. Neonates were randomly assigned into two groups receiving 100 mg/kg Curosurf or Survanta as soon as possible after randomization. Complications, mortality and needing the second dose were compared between the two groups. RESULTS: A total 112 patients with the mean gestational age of 32.59 ± 3.39 weeks were evaluated (56 patients in each group). There were no significant differences regarding birth weight, gestational age, delivery method, and parity between the two groups (P > 0.05). The complications were occurred in 18 neonates (32.1%) of Curosurf group and 20 neonates (35.7%) of Survanta group (RR = 0.922, 95% CI = 0.617-1.379). There were no significant differences regarding complications, mortality, and needing nasal CPAP and endotracheal tube between the two groups. In the neonates with gestational age of 29-32 weeks the IVH and NEC incidence were significantly more in Curosurf group compared to Survanta group (27.8% vs 0% and 22.3% vs 0%, P < 0.05). CONCLUSION: There was no significant difference in complications or mortality between those two groups; however Curosurf was associated with less need of ET tube (in >32 birth weeks subgroup) and NCPAP (in 29-32 birth weeks subgroup) (p = 0.008). Further evaluations with longer follow-up duration are needed for comparing these two surfactants.

Effect of pioglitazone therapy on high sensitive C-reactive protein and lipid profile in diabetic patients with renal transplantation; a randomize clinical trial.

BACKGROUND: Inflammation has a major role in disease lead to renal failure and diabetes mellitus, controlling inflammation in diabetic kidney receivers could decrease morbidity and mortality. OBJECTIVES: This study designed for evaluating the efficacy of pioglitazone on C-reactive protein and lipid profile in diabetic kidney transplant receivers. PATIENTS AND METHODS: In this double blinded clinical trial, 58 diabetic renal transplant receivers, in first month after transplantation, randomized into two groups; receiving insulin and pioglitazone (15 mg tablet daily, group A); and insulin and placebo (group B). Blood pressure, weight, body mass index (BMI) and laboratory data compared in before and after 4-month treatment in two groups by SPSS. RESULTS: Fifty-eight patients with mean age of 44.15 ± 2 years included. There were no significant difference between groups in demographic data and other baseline measured variables (P > 0.05) .The mean weigh and BMI were slightly increased in group A and decreased in group B. The mean hs-CRP was decreased 4.82 mg/dL in group A and 1.93 mg/dL in group B (P = 0.007). The mean total serum cholesterol was significantly decreased 34 mg/dL in group A and 18.07 mg/dL in group B (P = 0.027). The mean serum HDL-C was significantly increased 13.31 mg/dL in group A and 5.89 mg/dl in group B (P < 0.001). CONCLUSIONS: Pioglitazone seems to be a safe drug for reducing serum lipids and CRP in kidney transplant receivers with diabetes mellitus in short term. Long term effect of this drug could be evaluated in future studies.