A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis

NCT05865405 | Active Not Recruiting DMC

• 1 other identifier: 22-36620
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; MS; Depression

Keywords

MS; Multiple Sclerosis; Depression; Depressed

Outcome Measures

Primary Outcomes (7)

• Mood Screening - Primary

  Clinician screening of depression as documented in the electronic health record (EHR)

  0-6 months, 0-12 months

• Mood Reporting - Secondary

  The percentage of patients who self-report mood at each clinical visit

  6 months, Baseline, 12 months

• Comprehensive Mood Evaluation - Secondary

  The percentage of depression risk factors evaluated at each clinical visit

  0-6 months, 0-12 months

• Treatment recommendations - Secondary

  The percentage of visits in which applicable care was recommended; number of preventative care recommendations

  0-6 months, 0-12 months

• Treatment recommendation follow-through - Secondary

  The number/percent of preventative care recommendations followed through by next visit

  0-6 months, 0-12 months

• Adoption (uptake) - Primary

  The percentage of patients using the tool during the first month of the study

  Initial month

• Adoption (uptake) - Secondary

  The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit

  Baseline, 6 months

Secondary Outcomes (13)

• Mood scores - Primary

  Baseline, 3, 6, 9, and 12 months

• Mood scores - Exploratory

  12 months

• Mood scores - Exploratory

  0-12 months, 0-6 months, 6-12 months

• Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory

  0-12 months, 0-6 months, 6-12 months

• Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory

  0-12 months, 0-6 months, 6-12 months

Other Outcomes (2)

• Trial retention - Exploratory

  12 months

• Self-Efficacy - Exploratory

  Baseline-12 months

Study Arms (2)

Arm 1: 12 month MS CATCH tool intervention

EXPERIMENTAL

Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires.

Behavioral: MS CATCH

Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention

OTHER

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".

Behavioral: MS CATCH

Interventions

MS CATCH BEHAVIORAL

Participants will respond to a set of surveys every month to increase communication on mood with their clinician.

Arm 1: 12 month MS CATCH tool intervention; Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18
• Ages 18 to 80
• PHQ-9 score of 5-19
• Any MS therapy, or no treatment
• California resident to enable clinical telemedicine visits if warranted during the study visit

You may not qualify if:

• Cognitive dexterity or visual impairment (typically defined as corrected acuity less than 20/70) that, in the opinion of the study neurologist (RB), 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
• Substance abuse that in the treating neurologist's perspective could influence the patient's safety on study or adherence to study protocol
• Another co-morbid CNS diagnosis eg. TBI

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator

Study Sites (1)

Weill Institute for Neurosciences, University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (2)

• Henderson K, Reihm J, Koshal K, Wijangco J, Sara N, Miller N, Doyle M, Mallory A, Sheridan J, Guo CY, Oommen L, Rankin KP, Sanders S, Feinstein A, Mangurian C, Bove R. A Closed-Loop Digital Health Tool to Improve Depression Care in Multiple Sclerosis: Iterative Design and Cross-Sectional Pilot Randomized Controlled Trial and its Impact on Depression Care. JMIR Form Res. 2024 Mar 15;8:e52809. doi: 10.2196/52809.

  PMID: 38488827 DERIVED

• Henderson K, Reihm J, Koshal K, Wijangco J, Miller N, Sara N, Doyle M, Mallory A, Sheridan J, Guo CY, Oommen L, Feinstein A, Mangurian C, Lazar A, Bove R. 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. BMJ Open. 2024 Feb 24;14(2):e077432. doi: 10.1136/bmjopen-2023-077432.

  PMID: 38401894 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Depression; Consciousness Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to what arm participants are a part of.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both arm 1 and arm 2 groups of participants will receive at least 6 months of MS CATCH tool intervention, with arm 1 receiving 12 months of intervention

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 18, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months post trial
• Access Criteria: Qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement

Locations

US (1)