Multiple SclerosisMS-CATCHNCT05865405
A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis
A study testing MS CATCH in people with Multiple Sclerosis and MS, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, MS, Depression
- What is being tested?
- MS CATCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Institute for Neurosciences, University of California, San Francisco
San Francisco, California, 94158
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, MS, Depression
- Being tested
- MS CATCH
- Keywords
- MS, Multiple Sclerosis, Depression, Depressed
- Medical subject headings
- Multiple Sclerosis, Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS CATCHBehavioural
Participants will respond to a set of surveys every month to increase communication on mood with their clinician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: Behavioral: MS CATCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood Screening - Primary
Clinician screening of depression as documented in the electronic health record (EHR)
Measured: 0-6 months, 0-12 months
Mood Reporting - Secondary
The percentage of patients who self-report mood at each clinical visit
Measured: 6 months, Baseline, 12 months
Comprehensive Mood Evaluation - Secondary
The percentage of depression risk factors evaluated at each clinical visit
Measured: 0-6 months, 0-12 months
Treatment recommendations - Secondary
The percentage of visits in which applicable care was recommended; number of preventative care recommendations
Measured: 0-6 months, 0-12 months
Treatment recommendation follow-through - Secondary
The number/percent of preventative care recommendations followed through by next visit
Measured: 0-6 months, 0-12 months
Adoption (uptake) - Primary
The percentage of patients using the tool during the first month of the study
Measured: Initial month
Adoption (uptake) - Secondary
The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit
Measured: Baseline, 6 months
Secondary outcomes (13)
Mood scores - Primary
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
Measured: Baseline, 3, 6, 9, and 12 months
Mood scores - Exploratory
Mini-International Neuropsychiatric Interview (MINI) assessment
Measured: 12 months
Mood scores - Exploratory
Changes in Patient Health Questionnaire - 9 (PHQ-9), scale: 0-27, higher indicates more severe depressive symptoms
Measured: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory
Evaluating possible contributors to mood: fatigue (MFIS), scale: 0-84, higher score indicates more impact
Measured: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory
Evaluating possible contributors to mood: sleep (PSQI), scale: 0-21, higher scores indicates worse sleep quality
Measured: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory
Evaluating possible contributors to mood: engagement (Ox-PAQ), scale: 0-100, higher score indicates more problems with activity and participation
Measured: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Impact on Participation and Autonomy - Exploratory
Evaluating possible contributors to mood: participation (IPA), scale: 0-128, with higher score indicating more impact on a person's autonomy and participation
Measured: 0-12 months, 0-6 months, 6-12 months
Engagment (Sustained use) - Secondary
The percentage of patients who continue to use the patient-facing tool at least quarterly
Measured: Every 3 months
Engagement (Sustained use) - Secondary
The percentage of patient-clinician dyads in Arm 1 (early start) who continued to use the tool at the 12 month visit
Measured: 12 months
Engagement (Sustained use) - Exploratory
Length of each session
Measured: Baseline, 6 month, 12 month
Engagement (Sustained use) - Exploratoy
Qualitative feedback in exit interviews
Measured: 12 month
Engagement (Sustained use) - Exploratory
Net promoter score (NPS)
Measured: 12 month
Adherence - Secondary
The percentage of depression-reporting prompts responded to per participant on their patient-facing tool; the percentage participants responding to >75% depression prompts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Aug 2023
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865405
- Sponsor's protocol ID
- 22-36620
- Acronym
- MS-CATCH
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
Publications
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.
PubMed 38488827Henderson 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.
PubMed 38401894
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05865405
- Acronym / sponsor ID
- MS-CATCH / 22-36620
- Conditions
- Multiple Sclerosis, MS, Depression
- Keywords
- MS, Multiple Sclerosis, Depression, Depressed
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 12 month MS CATCH tool intervention | Experimental | Behavioral: MS CATCHParticipants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires. |
| Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention | Other | Behavioral: MS CATCHParticipants 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". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS CATCHParticipants will respond to a set of surveys every month to increase communication on mood with their clinician. | Behavioural | Arm 1: 12 month MS CATCH tool intervention, Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention |
Primary outcome
Mood Screening - Primary
Time frame: 0-6 months, 0-12 months
Clinician screening of depression as documented in the electronic health record (EHR)
Mood Reporting - Secondary
Time frame: 6 months, Baseline, 12 months
The percentage of patients who self-report mood at each clinical visit
Comprehensive Mood Evaluation - Secondary
Time frame: 0-6 months, 0-12 months
The percentage of depression risk factors evaluated at each clinical visit
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
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
Adoption (uptake) - Primary
Time frame: Initial month
The percentage of patients using the tool during the first month of the study
Adoption (uptake) - Secondary
Time frame: Baseline, 6 months
The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit
13 secondary outcomes
Mood scores - Primary
Time frame: Baseline, 3, 6, 9, and 12 months
Mood scores - Exploratory
Time frame: 12 months
Mood scores - Exploratory
Time frame: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory
Time frame: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory
Time frame: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory
Time frame: 0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Impact on Participation and Autonomy - Exploratory
Time frame: 0-12 months, 0-6 months, 6-12 months
Engagment (Sustained use) - Secondary
Time frame: Every 3 months
Engagement (Sustained use) - Secondary
Time frame: 12 months
Engagement (Sustained use) - Exploratory
Time frame: Baseline, 6 month, 12 month
Engagement (Sustained use) - Exploratoy
Time frame: 12 month
Engagement (Sustained use) - Exploratory
Time frame: 12 month
Adherence - Secondary
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 38488827Henderson 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.
- Derived from this study: PubMed 38401894Henderson 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.
- Individual participant dataSharing planned: Yes. The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riley Bove, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS CATCH in people with Multiple Sclerosis and MS, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Screening - Primary (time frame: 0-6 months, 0-12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.