Mobile App for Depression in Multiple Sclerosis

(MS-CATCH Trial)

Overseen By Kyra Henderson, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, Psychotic disorders, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called MS CATCH, designed to support people with multiple sclerosis (MS) who experience mood-related symptoms. The app allows patients to track their symptoms and share them with their neurologist to improve care between visits. The study includes two groups: one uses the app for 12 months, while the other receives usual care for 6 months before using the app for the next 6 months. The trial seeks California residents with MS who often feel down or experience mood swings. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance MS care.

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 prior data suggests that the MS CATCH app is safe for use in patients with Multiple Sclerosis?

A previous study tested the MS CATCH app to evaluate its effectiveness in depression care. This smartphone app enables users to report mood symptoms, which doctors can then review and receive alerts if concerns arise about a patient's mental health.

MS CATCH has shown to be safe for users, with no reports of negative side effects. It primarily aids in tracking mood symptoms and enhances communication with doctors. As it focuses on information sharing rather than medication or medical procedures, it serves as a low-risk tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MS CATCH tool because it offers a novel approach to managing depression in individuals with multiple sclerosis (MS). Unlike standard treatments such as medications or psychotherapy, MS CATCH is a mobile app designed to provide continuous support and monitoring through in-visit interventions and monthly questionnaires. This digital approach aims to be more accessible and personalized, allowing users to engage with their mental health management seamlessly throughout their daily lives. By integrating technology into mental health care, MS CATCH has the potential to enhance treatment adherence and effectiveness, offering a promising alternative to traditional methods.

What evidence suggests that the MS CATCH app is effective for depression in multiple sclerosis?

Research shows that the MS CATCH tool is designed to enhance communication between people with multiple sclerosis (MS) and their doctors regarding depression. It collects information on mood symptoms and alerts doctors to any concerning changes, enabling a quick response to mental health needs. Participants in this trial will be divided into two groups: one group will receive the MS CATCH tool intervention for 12 months, while the other group will receive "usual care" for 6 months, followed by 6 months of the MS CATCH tool intervention. The tool aims to improve overall care by keeping doctors updated on patients' mood changes in real time. Although specific data on its effectiveness for depression in MS is still being collected, similar digital tools have shown promise in enhancing mental health communication and outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Riley Bove, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

California resident to enable clinical telemedicine visits if warranted during the study visit

Exclusion Criteria

Inability to provide informed consent

Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder

Substance abuse that could influence the patient's safety on study or adherence to study protocol

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MS CATCH

Trial Overview The 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.

How Is the Trial Designed?

Group I: Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention Experimental Treatment 1 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 intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The MS Energize app, designed for self-management of fatigue in people with multiple sclerosis, was positively received by 11 participants over a 5-6 week period, validating their experiences and providing useful strategies based on cognitive-behavioral therapy principles.

Feedback indicated that while the app was generally helpful, it had usability issues, particularly due to excessive text, which could contribute to fatigue, highlighting the need for further refinement before clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MS Energize: Field trial of an app for self-management of fatigue for people with multiple sclerosis. Babbage, DR., van Kessel, K., Drown, J., et al.[2020]

A study involving 24 participants with multiple sclerosis (MS) across the UK, Spain, and Italy identified key barriers and facilitators for using smartphone apps and wearable devices in managing health, highlighting the need for technology that accommodates varying physical abilities.

Common themes included the importance of providing information and memory aids, as well as addressing potential negative effects on mood, suggesting that future mHealth interventions should focus on user control and practical support to enhance engagement among individuals with both relapsing remitting and progressive MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging across dimensions of diversity: A cross-national perspective on mHealth tools for managing relapsing remitting and progressive multiple sclerosis. Simblett, SK., Evans, J., Greer, B., et al.[2019]

The BRISA app, used by 2095 multiple sclerosis patients in Germany, revealed that most users are female and aged between 26 and 55, with relapsing-remitting MS being the most common type.

The study identified fatigue, concentration disorders, tingling, forgetfulness, and pain as the top symptoms affecting users, emphasizing the need for personalized disease management strategies based on real-world data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. Balakrishnan, P., Groenberg, J., Jacyshyn-Owen, E., et al.[2022]

In a study involving 97 patients with multiple sclerosis, adherence to a smartphone-based e-diary for reporting patient-reported outcomes (PROs) was high, with 78% completing the 12-month period and 55% submitting at least 75% of surveys.

The e-diary derived bodily function summary score (eBF) was found to significantly predict quality of life and changes in eBF scores over time were associated with MS relapses, indicating that this tool could enhance clinical care and research for patients with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Golan, D., Sagiv, S., Glass-Marmor, L., et al.[2023]

A scoping review identified 35 unique wearable technology products for monitoring various aspects of multiple sclerosis (MS), including gait, cognition, and mood, highlighting the potential for continuous and remote patient monitoring.

Despite the variety of available solutions, there is currently no consensus on the best wearable technology for use in MS research or clinical practice, indicating a need for further evaluation of factors like scalability, cost, and accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technologies to measure clinical outcomes in multiple sclerosis: A scoping review. Alexander, S., Peryer, G., Gray, E., et al.[2023]

A new digital care management platform for multiple sclerosis (MS) includes a patient app and MRI quantification tools, showing high interest from patients (95.6% want to use the app) and significant improvements in detecting disease activity.

The platform improved sensitivity for detecting disease progression from 24% to 76% compared to standard MRI readings, indicating its potential to enhance care management for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Digital Care Management Platform to Monitor Clinical and Subclinical Disease Activity in Multiple Sclerosis. Van Hecke, W., Costers, L., Descamps, A., et al.[2021]

Digital technology tools are increasingly being integrated into clinical trials for multiple sclerosis (MS), enhancing treatment delivery and disease monitoring through methods like psychotherapy apps and robot-assisted exercises.

These technologies improve the standardization of outcome measures and enable better detection of symptoms and treatment adherence, shifting data collection from traditional paper-based methods to more efficient internet-based systems, which can also facilitate remote rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. De Angelis, M., Lavorgna, L., Carotenuto, A., et al.[2021]

eHealth technologies, including mobile apps, significantly improve access to care and health outcomes for patients with multiple sclerosis (MS) by enabling self-management and remote monitoring, addressing barriers like mobility and travel costs.

The review identified 28 eHealth solutions that support various aspects of MS management, highlighting their potential to enhance patient engagement and streamline healthcare delivery, although challenges to widespread adoption remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review. Marziniak, M., Brichetto, G., Feys, P., et al.[2020]

The digital health application 'levidex' was found to be practical and acceptable for people with multiple sclerosis (pwMS) with moderate to severe disability, as evidenced by positive participant feedback and a completion rate of 47.4% for all modules over a six-month period.

While the study showed that levidex could facilitate health behavior changes, no significant improvements were observed in secondary outcomes like empowerment or stress management, indicating the need for further research with larger sample sizes and longer follow-up to assess its true efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study. Kutzinski, M., Krause, N., Riemann-Lorenz, K., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38488827/

A Closed-Loop Digital Health Tool to Improve Depression ... MS CATCH is a closed-loop system aimed to increase communication about depression between people living with MS and their clinicians, and ultimately improve ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38401894/

Pragmatic phase II clinical trial to improve depression care ... MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05865405

Study Details | NCT05865405 | A Closed Loop, Doctor to ... 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 ...

4. ijmsc.org ijmsc.org/view/computerized-cognitive-behavioral-therapy-for-treatment-of-depression-in-multiple-sclerosis

Computerized Cognitive Behavioral Therapy for Treatment ... A pilot study of MS Invigor8 by Moss-Morris et al 50 demonstrated that the intervention is feasible for patients with MS and may reduce fatigue ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00109-7/fulltext

a multicentre, randomised, controlled, phase 3 trial This trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10980989/

A Closed-Loop Digital Health Tool to Improve Depression ... This study aims to design a closed-loop tool to improve depression care for these patients. It would support regular depression screening, tie into the point ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895222/

Pragmatic phase II clinical trial to improve depression care in ... The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting.

8. escholarship.org escholarship.org/uc/item/40b287tm

Pragmatic phase II clinical trial to improve depression care ... The tool, MS CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with MS), closes the communication loop between ...