Depression
Conditions
Brief summary
Previous research by Mental Health Research Network (MHRN) investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently address premature discontinuation of depression treatment. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white populations. Less is known about the acceptability and effectiveness of different communication modalities (online messaging, mailed letters, telephone) among racial and ethnic minority populations. Implementation of electronic-Health (eHealth) technologies must take care not to exacerbate health disparities. This clinical trial involves a pilot trial to evaluate a population-based outreach program to improve rates of depression treatment initiation among traditionally underserved racial and ethnic groups. This pilot work intends to inform a subsequent full-scale pragmatic trial to examine impact on health disparities.
Interventions
BEHAVIORALOutreach messaging
Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis.
Sponsors
Kaiser Permanente
Henry Ford Health System
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis of major depressive disorder or dysthymic disorder at a primary care visit ("new" defined as no depression diagnosis, psychotherapy visit or filled antidepressant prescription in the prior year) * Continuously enrolled in the participating health system for 365 days prior to the eligible diagnosis (to assure capture of prior diagnoses or treatments) * Patients Health Questionnaire-9 (PHQ-9) depression score of 10 or more within 14 days before to 7 days after the eligible diagnosis * No filled prescription for any antidepressant medication OR psychotherapy visit attended within 30 days of the eligible diagnosis\* * No recorded PHQ-9 depression score less than 5 since the eligible diagnosis * At least 18 years of age or older
Exclusion criteria
* Diagnosis of schizophrenia or bipolar disorder in the prior 2 years * Not registered to use Electronic Health Record (EHR) patient portal * Previously requested to not be contacted for research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Initiation of Formal Depression Treatment | within 60 days of randomization | Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 19.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| PHQ-9 total score | 14.2 units on a scale STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 67 Participants |
| Race (NIH/OMB) Black or African American | 116 Participants |
| Race (NIH/OMB) More than one race | 74 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 17 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 152 participants |
| Sex: Female, Male Female | 207 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 152 | 0 / 157 |
| other Total, other adverse events | 0 / 152 | 0 / 157 |
| serious Total, serious adverse events | 0 / 152 | 0 / 157 |
Outcome results
None listed