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

100 Participants Needed

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. ^{1 2 3 4 5}

Is the mobile app for depression in multiple sclerosis safe for humans?

The research on digital health applications for multiple sclerosis, including mobile apps, suggests they are generally safe for humans. These apps are designed to improve access to care and help with self-management, and there is no indication of safety concerns in the studies reviewed. ^{1 2 4 6 7}

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. ^{1 2 3 8 9}

Research Team

Riley Bove, MD

Principal Investigator

University of California, San Francisco

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.

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

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands 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. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

MS Energize: Field trial of an app for self-management of fatigue for people with multiple sclerosis. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review. [2020]

5. United States 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Digital Care Management Platform to Monitor Clinical and Subclinical Disease Activity in Multiple Sclerosis. [2021]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Wearable technologies to measure clinical outcomes in multiple sclerosis: A scoping review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. [2022]