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Active, Not Recruiting

NCT Number: NCT05865405

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Consciousness Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Immune System Diseases MS Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Institute for Neurosciences, University of California, San Francisco

San Francisco, California, 94158, United States

About this study

MS-CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with Multiple Sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. It consists of a simple tool used by the patient to improve mood reporting. This then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. This dashboard launches straight from the patient's electronic health record (EHR). MS-CATCH was designed using extensive human-centered design in all phases of development, and HIPAA compliant REDCap for electronic data capture. While the tool requires institutional approvals to launch within the UCSF EHR, the design elements could be readily repurposed using these technologies to support other institutions' requirements. Each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the COM-B (Capability, Opportunity, and Motivation to change Behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MS CATCH

Behavioral

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

Primary outcomes

  1. Mood Screening - Primary

    Time frame: 0-6 months, 0-12 months

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

  2. Mood Reporting - Secondary

    Time frame: 6 months, Baseline, 12 months

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

  3. Comprehensive Mood Evaluation - Secondary

    Time frame: 0-6 months, 0-12 months

    The percentage of depression risk factors evaluated at each clinical visit

  4. Treatment recommendations - Secondary

    Time frame: 0-6 months, 0-12 months

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

  5. Treatment recommendation follow-through - Secondary

    Time frame: 0-6 months, 0-12 months

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

  6. Adoption (uptake) - Primary

    Time frame: Initial month

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

  7. Adoption (uptake) - Secondary

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Mood scores - Primary

    Time frame: Baseline, 3, 6, 9, and 12 months

    Hospital Anxiety Depression Scale (HADS) will be measured at baseline, 3, 6, 9, and 12 months, scale: 0-21 range for depressive scale, and 0-21 range for anxiety scale, with higher score meaning more depressive or anxious symptoms

  2. Mood scores - Exploratory

    Time frame: 12 months

    Mini-International Neuropsychiatric Interview (MINI) assessment

  3. Mood scores - Exploratory

    Time frame: 0-12 months, 0-6 months, 6-12 months

    Changes in Patient Health Questionnaire - 9 (PHQ-9), scale: 0-27, higher indicates more severe depressive symptoms

  4. Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory

    Time frame: 0-12 months, 0-6 months, 6-12 months

    Evaluating possible contributors to mood: fatigue (MFIS), scale: 0-84, higher score indicates more impact

  5. Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory

    Time frame: 0-12 months, 0-6 months, 6-12 months

    Evaluating possible contributors to mood: sleep (PSQI), scale: 0-21, higher scores indicates worse sleep quality

  6. Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory

    Time frame: 0-12 months, 0-6 months, 6-12 months

    Evaluating possible contributors to mood: engagement (Ox-PAQ), scale: 0-100, higher score indicates more problems with activity and participation

  7. Other self-reported outcome - Impact on Participation and Autonomy - Exploratory

    Time frame: 0-12 months, 0-6 months, 6-12 months

    Evaluating possible contributors to mood: participation (IPA), scale: 0-128, with higher score indicating more impact on a person's autonomy and participation

  8. Engagment (Sustained use) - Secondary

    Time frame: Every 3 months

    The percentage of patients who continue to use the patient-facing tool at least quarterly

  9. Engagement (Sustained use) - Secondary

    Time frame: 12 months

    The percentage of patient-clinician dyads in Arm 1 (early start) who continued to use the tool at the 12 month visit

  10. Engagement (Sustained use) - Exploratory

    Time frame: Baseline, 6 month, 12 month

    Length of each session

  11. Engagement (Sustained use) - Exploratoy

    Time frame: 12 month

    Qualitative feedback in exit interviews

  12. Engagement (Sustained use) - Exploratory

    Time frame: 12 month

    Net promoter score (NPS)

  13. Adherence - Secondary

    Time frame: 12 months

    The percentage of depression-reporting prompts responded to per participant on their patient-facing tool; the percentage participants responding to >75% depression prompts

Other outcomes

  1. Trial retention - Exploratory

    Time frame: 12 months

    Trial retention

  2. Self-Efficacy - Exploratory

    Time frame: Baseline-12 months

    Changes in patient reported self efficacy at managing a chronic disease, reported using the "Self-efficacy for Managing a Chronic Disease 6-item Scale" (Lorig) Questionnaire.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in Patients With Multiple Sclerosis: Closing the Gaps in Depression Care for People With MS By Closing the Information Loop

Acronym: MS-CATCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 18, 2023
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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