Randomized Controlled Trial of Occupational Performance Coaching for Adults With Multiple Sclerosis.

OBJECTIVE: To determine if the receipt of occupational performance coaching (OPC) by adults living with multiple sclerosis (MS) improves participants' satisfaction with performance in daily activities (primary outcome); improves perceived performance in daily activities, resilience, autonomy, and participation; and reduces illness intrusiveness and effect of MS (secondary outcomes). DESIGN: Two-group randomized clinical trial with a waitlist control. SETTING: Community. PARTICIPANTS: Convenience sample of adults with MS were recruited through a research registry. Eighty-three individuals were approached; 35 were assessed for eligibility and 31 were enrolled and 30 completed baseline assessment (Final sample size, N=30). Participants were English-speaking, were without serious cognitive impairment or severe depression, and were not receiving other coaching interventions. INTERVENTIONS: Six telephone sessions of OPC were delivered by a trained facilitator over 10 weeks. Initial sessions focused on goal setting, prioritization, and action planning. Subsequent sessions involved goal and action plan review, discussion of facilitators and barriers, and goal and plan refinement. MAIN OUTCOME MEASURES: Primary outcome was participants' satisfaction with performance in daily activities, as measured by the Canadian Occupational Performance Measure (COPM). Secondary outcome measures included the COPM performance rating, Connor-Davidson Resilience Scale, Impact on Participation and Autonomy Questionnaire, Adapted Illness Intrusiveness Rating Scale, and MS Impact Scale. Measures were administered by a blinded assessor at baseline, 10 weeks, and 2 months. RESULTS: Participants in the intervention and waitlist control groups were equivalent on demographic and outcome measures at baseline. At 10 weeks, the intervention group had significantly higher COPM ratings for both satisfaction (P<.001) and performance (P=.002). No other outcomes were significantly different. For the intervention group, the benefits of OPC were maintained at 2 months. CONCLUSIONS: OPC led to improved satisfaction with performance and performance in daily activities. Future research with a larger sample is needed to determine other effects and who benefits most from OPC.

Making Sense of Vagus Nerve Stimulation for Stroke.

Implantable vagus nerve stimulation, paired with high-dose occupational therapy, has been shown to be effective in improving upper limb function among patients with stroke and received regulatory approval from the US Food and Drug Administration and the Centers for Medicare & Medicaid Services. Combining nonsurgical and surgical approaches of vagus nerve stimulation in recent meta-analyses has resulted in misleading reports on the efficacy of each type of stimulation among patients with stroke. This article aims to clarify the confusion surrounding implantable vagus nerve stimulation as a poststroke treatment option, highlighting the importance of distinguishing between transcutaneous auricular vagus nerve stimulation and implantable vagus nerve stimulation. Recent meta-analyses on vagus nerve stimulation have inappropriately combined studies of fundamentally different interventions, outcome measures, and participant selection, which do not conform to methodological best practices and, hence, cannot be used to deduce the relative efficacy of the different types of vagus nerve stimulation for stroke rehabilitation. Health care providers, patients, and insurers should rely on appropriately designed research to guide well-informed decisions.

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.

Using electronically delivered therapy and brain imaging to understand OCD pathology: A pilot feasibility study.

Background: Obsessive-compulsive disorder (OCD) is a debilitating mental health disorder with current psychotherapeutic treatments, while somewhat effective, yielding low accessibility and scalability. A lack of knowledge regarding the neural pathology of OCD may be hindering the development of innovative treatments. Previous research has observed baseline brain activation patterns in OCD patients, elucidating some understanding of the implications. However, by using neuroimaging to observe the effects of treatment on brain activation, a more complete picture of OCD can be drawn. Currently, the gold standard treatment is cognitive behavioral therapy (CBT). However, CBT is often inaccessible, time-consuming, and costly. Fortunately, it can be effectively delivered electronically (e-CBT). Objectives: This pilot study implemented an e-CBT program for OCD and observed its effects on cortical activation levels during a symptom provocation task. It was hypothesized that abnormal activations could be attenuated following treatment. Methods: OCD patients completed a 16-week e-CBT program administered through an online platform, mirroring in-person content. Treatment efficacy was evaluated using behavioral questionnaires and neuroimaging. Activation levels were assessed at the resting state and during the symptom provocation task. Results: In this pilot, seven participants completed the program, with significant improvements (p < 0.05) observed between baseline and post-treatment for symptom severity and levels of functioning. No statistically significant (p = 0.07) improvement was observed in the quality of life. Participants had mostly positive qualitative feedback, citing accessibility benefits, comprehensive formatting, and relatable content. No significant changes in cortical activation were observed between baseline and post-treatment. Conclusion: This project sheds light on the application of e-CBT as a tool to evaluate the effects of treatment on cortical activation, setting the stage for a larger-scale study. The program showed great promise in feasibility and effectiveness. While there were no significant findings regarding changes in cortical activation, the trends were in agreeance with previous literature, suggesting future work could provide insight into whether e-CBT offers comparable cortical effects to in-person psychotherapy. Applying a greater knowledge of the neural mechanisms of action in OCD can help develop novel treatment plans in the future.

Using Electronically Delivered Therapy and Brain Imaging to Understand Obsessive-Compulsive Disorder Pathophysiology: Protocol for a Pilot Study.

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.

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.