Pragmatic phase II clinical trial to improve depression care in a real-world diverse MS cohort from an academic MS centre in Northern California: MS CATCH study protocol.

Feb 26, 2024

Experts: Kyra Henderson, Jennifer Reihm, Kanishka Koshal, Jaeleene Wijangco, Nicolette Miller, Narender Sara, Marianne Doyle, Alicia Mallory, Judith Sheridan, Chu-Yueh Guo, Lauren Oommen, Anthony Feinstein, Christina Mangurian, Ann Lazar, Riley Bove

Depression occurs in over 50% of individuals living with multiple sclerosis (MS) and can be treated using many modalities. Yet, it remains: under-reported by patients, under-ascertained by clinicians and under-treated. To enhance these three behaviours likely to promote evidence-based depression care, we engaged multiple stakeholders to iteratively design a first-in-kind digital health tool. 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 patients and clinicians. Between clinical visits, the tool queries patients monthly about mood symptoms, supports patient self-management and alerts clinicians to worsening mood via their electronic health record in-basket. Clinicians can also access an MS CATCH dashboard displaying patients’ mood scores over the course of their disease, and providing comprehensive management tools (contributing factors, antidepressant pathway, resources in patient’s neighbourhood). The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting.
MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression. Arm 1 will receive MS CATCH for 12 months, and arm 2 will receive usual care for 6 months, then MS CATCH for 6 months. Clinicians will be randomised to avoid practice effects. The effectiveness analysis is superiority intent-to-treat comparing MS CATCH to usual care over 6 months (primary outcome: evidence of screening and treatment; secondary outcome: Hospital Anxiety Depression Scale-Depression scores). The usability of the intervention will also be evaluated (primary outcome: adoption; secondary outcomes: adherence, engagement, satisfaction).
University of California, San Francisco Institutional Review Board (22-36620). The findings of the study are planned to be shared through conferences and publishments in a peer-reviewed journal. The deidentified dataset will be shared with qualified collaborators on request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analysed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
NCT05865405.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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ABOUT THE EXPERTS

Kyra Henderson, Jennifer Reihm, Kanishka Koshal, Jaeleene Wijangco, Nicolette Miller, Narender Sara, Marianne Doyle, Alicia Mallory, Judith Sheridan, Chu-Yueh Guo, Lauren Oommen, Anthony Feinstein, Christina Mangurian, Ann Lazar, Riley Bove

Kyra Henderson

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Jennifer Reihm

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Kanishka Koshal

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Jaeleene Wijangco

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Nicolette Miller

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Narender Sara

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Marianne Doyle

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Alicia Mallory

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Judith Sheridan

Patient Stakeholder, University of California San Francisco, San Francisco, California, USA.

Chu-Yueh Guo

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Lauren Oommen

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA.

Anthony Feinstein

Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.

Christina Mangurian

Department of Psychiatry, University of California San Francisco, San Francisco, California, USA.

Ann Lazar

Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.

Riley Bove

UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, California, USA Riley.bove@ucsf.edu.