Mobile App for Depression in Multiple Sclerosis
(MS-CATCH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Cognitive impairment, Psychotic disorders, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. It seems you can continue any MS therapy or have no treatment at all.
What data supports the effectiveness of the treatment MS CATCH for depression in patients with Multiple Sclerosis?
Research shows that mobile apps and digital tools can help manage multiple sclerosis by improving access to care and supporting self-management. Apps like MS Energize, which use cognitive-behavioral therapy principles, have been found useful for managing symptoms like fatigue, suggesting potential benefits for addressing depression as well.12345
Is the mobile app for depression in multiple sclerosis safe for humans?
How does the mobile app for depression in multiple sclerosis differ from other treatments?
This mobile app is unique because it uses digital technology to help manage depression in multiple sclerosis by providing self-management tools and education based on cognitive-behavioral therapy principles. Unlike traditional treatments, it offers interactive tasks and supports users in applying these principles to their daily lives, making it a novel approach to addressing mental health in MS patients.12389
Eligibility Criteria
This trial is for California residents aged 18-80 with Multiple Sclerosis, who can use a mobile app and have mild to moderate depression. They must be able to give consent and follow the study plan without being limited by cognitive or visual issues, and should not have bipolar disorder, schizophrenia, or schizoaffective disorder.Inclusion Criteria
PHQ-9 score of 5-19
I have been diagnosed with multiple sclerosis according to the 2017 criteria.
I am between 18 and 80 years old.
See 2 more
Exclusion Criteria
Cognitive dexterity or visual impairment that would put the participant at risk or limit their ability to adhere to the study protocol
Inability to provide informed consent
Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Usual Care
Participants receive usual care for 6 months to assess the definition of 'usual care'
6 months
Regular clinical visits
MS CATCH Tool Intervention
Participants use the MS CATCH tool for mood reporting and receive in-visit interventions and monthly questionnaires
6 months
Monthly questionnaires and clinical visits
Follow-up
Participants are monitored for sustained use of the MS CATCH tool and mood reporting
12 months
Quarterly assessments
Treatment Details
Interventions
- MS CATCH (Behavioral Intervention)
Trial OverviewThe MS CATCH smartphone application is being tested to see if it improves patient care in those with Multiple Sclerosis and depression. It lets patients report mood symptoms regularly for their neurologist to monitor through their medical records.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: 6 month "usual care", 6 month MS CATCH tool interventionExperimental Treatment1 Intervention
Participants in arm 2 will receive 6 months "usual care" followed by 6 months of MS CATCH tool intervention. These first 6 months will be used to assess the definition of "usual care".
Group II: Arm 1: 12 month MS CATCH tool interventionExperimental Treatment1 Intervention
Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Institute for Neurosciences, University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
United States Department of DefenseCollaborator
References
Engaging across dimensions of diversity: A cross-national perspective on mHealth tools for managing relapsing remitting and progressive multiple sclerosis. [2019]Smartphone apps and wearable devices could augment clinical practice by detecting changes in health status for multiple sclerosis (MS). This study sought to investigate potential barriers and facilitators for uptake and sustained use in (i) people with both relapsing remitting MS (RRMS) and progressive MS (PMS) and (ii) across different countries.
Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. [2021]Clinical trials in multiple sclerosis (MS) have been including digital technology tools to overcome limitations in treatment delivery and disease monitoring. In March 2020, we conducted a systematic search on pubmed.gov and clinicaltrials.gov databases (with no restrictions) to identify all relevant published and unpublished clinical trials, in English language, including MS patients, in which digital technology was applied. We used "multiple sclerosis" and "clinical trial" as the main search words, and "app", "digital", "electronic", "internet" and "mobile" as additional search words, separately. Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Digital technology has been used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms (e.g., electronic recording of motor performance). Other clinical trials have been using digital technology for monitoring symptoms that would be otherwise difficult to detect (e.g., fatigue, balance), for measuring treatment adherence and side effects, and for self-assessment purposes. Collection of outcome measures is progressively shifting from paper-based on site, to internet-based on site, and, in the future, to internet-based at home, with the detection of clinical and treatment features that would have remained otherwise invisible. Similarly, remote interventions provide new possibilities of motor and cognitive rehabilitation.
MS Energize: Field trial of an app for self-management of fatigue for people with multiple sclerosis. [2020]Multiple sclerosis (MS) is a lifelong neurological condition affecting around 2.2 million people worldwide. There are a wide range of symptoms, with fatigue reported as one of the most troublesome. MS Energize-or MS Energise in UK English regions-is an iPhone app focused on self-management of fatigue for people with MS. Based on cognitive-behavioral therapy principles, the app covers MS fatigue, how to use energy effectively, how behavior, thoughts and emotions interact and impact on MS fatigue, as well as the potential effects of bodily and environmental factors. MS Energize provides education, interactive tasks, and supports application of the principles into a user's day-to-day life. We field tested the usability and perceived usefulness of MS Energize with 11 people with longstanding multiple sclerosis in New Zealand and the United Kingdom. Participants used the app over a period of five to six weeks after which they rated the usability of the app and participated in an in-depth qualitative interview. We developed four main themes through our thematic analysis. 1. Validation of participants' own experiences of living with MS fatigue. 2. The personal cost in engaging with such an intervention. 3. Reframing experiences and adding to knowledge. 4. That the app was generally a good idea. Field testers' feedback also identified usability issues that could be addressed. In particular, the amount of text-based content in the app contributed to the app itself being fatiguing. This field-testing process has highlighted the value of the app while also guiding our roadmap for further developments to enhance usability and usefulness. The next step is further refinement of components of MS Energize in preparation for a trial of its clinical and cost effectiveness.
The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review. [2020]Despite recent advances in multiple sclerosis (MS) care, many patients only infrequently access health care services, or are unable to access them easily, for reasons such as mobility restrictions, travel costs, consultation and treatment time constraints, and a lack of locally available MS expert services. Advances in mobile communications have led to the introduction of electronic health (eHealth) technologies, which are helping to improve both access to and the quality of health care services. As the Internet is now readily accessible through smart mobile devices, most people can take advantage of eHealth apps. The development of digital applications and remote communication technologies for patients with MS has increased rapidly in recent years. These apps are intended to complement traditional in-clinic approaches and can bring significant benefits to both patients with MS and health care providers (HCPs). For patients, such eHealth apps have been shown to improve outcomes and increase access to care, disease information, and support. These apps also help patients to participate actively in self-management, for example, by tracking adherence to treatment, changes in bladder and bowel habits, and activity and mood. For HCPs, MS eHealth solutions can simplify the multidisciplinary approaches needed to tailor MS management strategies to individual patients; facilitate remote monitoring of patient symptoms, adverse events, and outcomes; enable the efficient use of limited resources and clinic time; and potentially allow more timely intervention than is possible with scheduled face-to-face visits. These benefits are important because MS is a long-term, multifaceted chronic condition that requires ongoing monitoring, assessment, and management. We identified in the literature 28 eHealth solutions for patients with MS that fall within the four categories of screening and assessment, disease monitoring and self-management, treatment and rehabilitation, and advice and education. We review each solution, focusing on any clinical evidence supporting their use from prospective trials (including ASSESS MS, Deprexis, MSdialog, and the Multiple Sclerosis Performance Test) and consider the opportunities, barriers to adoption, and potential pitfalls of eHealth technologies in routine health care.
Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis. [2023]The applicability of mobile digital technology to promote clinical care of people with multiple sclerosis (pwMS) is gaining increased interest as part of the implementation of patient-centered approaches. We aimed at assessing adherence to a smartphone-based e-diary, which was designed to collect patient-reported outcomes (PROs). Secondary objectives were to evaluate the construct and predictive validity of e-diary derived PROs and to explore the various factors that were associated with changes in PROs over time.
A Novel Digital Care Management Platform to Monitor Clinical and Subclinical Disease Activity in Multiple Sclerosis. [2021]In multiple sclerosis (MS), the early detection of disease activity or progression is key to inform treatment changes and could be supported by digital tools. We present a novel CE-marked and FDA-cleared digital care management platform consisting of (1) a patient phone/web application and healthcare professional portal (icompanion) including validated symptom, disability, cognition, and fatigue patient-reported outcomes; and (2) clinical brain magnetic resonance imaging (MRI) quantifications (icobrain ms). We validate both tools using their ability to detect (sub)clinical disease activity (known-groups validity) and real-world data insights. Surveys showed that 95.6% of people with MS (PwMS) were interested in using an MS app, and 98.2% were interested in knowing about MRI changes. The icompanion measures of disability (p < 0.001) and symptoms (p = 0.005) and icobrain ms MRI parameters were sensitive to (sub)clinical differences between MS subtypes. icobrain ms also decreased intra- and inter-rater lesion count variability and increased sensitivity for detecting disease activity/progression from 24% to 76% compared to standard radiological reading. This evidence shows PwMS' interest, the digital care platform's potential to improve the detection of (sub)clinical disease activity and care management, and the feasibility of linking different digital tools into one overarching MS care pathway.
Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study. [2023]Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application "levidex" was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health.
Wearable technologies to measure clinical outcomes in multiple sclerosis: A scoping review. [2023]Wearable technology refers to any sensor worn on the person, making continuous and remote monitoring available to many people with chronic disease, including multiple sclerosis (MS). Daily monitoring seems an ideal solution either as an outcome measure or as an adjunct to support rater-based monitoring in both clinical and research settings. There has been an increase in solutions that are available, yet there is little consensus on the most appropriate solution to use in either MS research or clinical practice. We completed a scoping review (using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines) to summarise the wearable solutions available in MS, to identify those approaches that could potentially be utilised in clinical trials, by evaluating the following: scalability, cost, patient adaptability and accuracy. We identified 35 unique products that measure gait, cognition, upper limb function, activity, mood and fatigue, with most of these solutions being phone applications.
Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. [2022]Multiple sclerosis (MS) is a chronic, progressive neurological autoimmune disease impacting quality of life. BRISA is an app designed to help MS patients in Germany track their disease course by symptom-monitoring. This study aimed to understand demographic and health-related characteristics of BRISA users.