N/A
Completed N=179
Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
Source: ClinicalTrials.gov NCT04891224 ↗Enrolled (actual)
179
Serious AEs
5.6%
Results posted
Mar 2025
Primary outcomePrimary: Proportion of Patients Who Completed Patient Health Questionnaire — 35; 49 participants
Summary
This study was conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with their doctor. Investigators compared the effect of the app over 6 months and examine whether the app can increase engagement between patients and their doctor and help in the management of illnesses as patients started a new treatment for depression. The investigators hoped that using an app to facilitate management of depression symptoms, medication use, and side effects help patients and their providers understand their response to medications and lead to better response and improvements in depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Completed Patient Health Questionnaire |
35; 49 | — |
| SECONDARY Process Outcome: Measurement-based Care |
38; 40 | — |
| SECONDARY Process Outcome: Shared-decision Making |
— | — |
| SECONDARY Process Outcome: Referrals to Behavioral Health |
21; 8 | — |
| SECONDARY Process Outcome: Total Number of Hospitalized Participants During Follow up Period |
19; 23 | — |
| SECONDARY Process Outcome: Follow-up After Emergency Department Visit for Mental Illness |
3; 0 | — |
| SECONDARY Process Outcome: Healthcare Resource Utilization, Hospital Admissions |
19; 23; 4; 0 | — |
| SECONDARY Process Outcome: Number of Behavioral Related Hospitalizations |
4; 0 | — |
| SECONDARY Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions |
11; 5 | — |
| SECONDARY Process Outcome: Healthcare Resource Utilization, Outpatient Visits |
11; 5; 11; 5; 216; 243 | — |
| SECONDARY Process Outcome: Primary Care Physician (PCP) Visits |
— | — |
| SECONDARY Patient Health Questionnaire-9 [PHQ-9] Score |
14.5; 12; 11.0; 8.5; 17.0; 6.5 | — |
| SECONDARY Patient Health Questionnaire-9 [PHQ-9] Score Reduction |
2; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
- Recently prescribed monotherapy antidepressant medication (defined as new start, medication switch, or dose change in the past 3 months.)
- Patients with inadequate response or tolerability concerns determined based on A PHQ-2 score of 3 or greater or a PHQ-9 score of 5 or more, recorded in medical records in the past 6 weeks or during screening,
- Able and willing to provide informed consent
- Able to use the Pathway Platform based on clinician's judgment, e.g. owns an iPhone version 5 or later or smartphones with Android operating systems, have an active data plan or regular WiFi access
Exclusion Criteria
- Missing PHQ-2 score in the past 6 weeks and/or unable to perform PHQ-2 at index visit
- Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder
- Patient no longer under primary care for depression and has transitioned to a psychiatric care team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, Psychiatric Physician Assistant).
- Lack of functional English literacy (indicated by primary language in electronic medical record).
Data sourced from ClinicalTrials.gov (NCT04891224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.