An interventional study of Outreach messaging in Depression, sponsored by Kaiser Permanente. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 309 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
Behavioral: Outreach 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.
Number of Participants With Initiation of Formal Depression Treatment
Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
Time frame: within 60 days of randomization
| Milestone | Usual Care | Outreach Messaging |
|---|---|---|
| Started | 152 | 157 |
| Completed | 152 | 113 |
| Not completed | 0 | 44 |
| Withdrew: Did not read message or was not reached via telephone | 0 | 44 |
Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
| Participants | Usual Care | Outreach Messaging |
|---|---|---|
| Number of Participants With Initiation of Formal Depression Treatment | 9 | 36 |
Collected over Adverse event data were collected from randomization to 60-days post-randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 0/152 (0%) | 0/152 (0%) | 0/152 (0%) |
| Outreach Messaging | 0/157 (0%) | 0/157 (0%) | 0/157 (0%) |
Individuals randomly assigned to usual care or outreach messaging
| Age, Continuous(years) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| Mean | 49.8 ± 19.5 | 49.5 ± 19.3 | 49.7 ± 19.4 |
| Sex: Female, Male(Participants) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| Female | 98 | 109 | 207 |
| Male | 54 | 48 | 102 |
| Race (NIH/OMB)(Participants) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 37 | 30 | 67 |
| Native Hawaiian or Other Pacific Islander | 17 | 21 | 38 |
| Black or African American | 56 | 60 | 116 |
| White | 5 | 4 | 9 |
| More than one race | 36 | 38 | 74 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 12 | 20 |
| Not Hispanic or Latino | 144 | 145 | 289 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| United States | 152 | 157 | 309 |
| PHQ-9 total score(units on a scale) | Usual Care | Outreach Messaging | Total |
|---|---|---|---|
| Mean | 14.5 ± 4.2 | 13.9 ± 3.6 | 14.2 ± 3.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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