Trial Outcomes & Findings for Outreach to Reduce Depression Disparities (NCT NCT05580406)
NCT ID: NCT05580406
Last Updated: 2026-05-01
Results Overview
Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
309 participants
Primary outcome timeframe
within 60 days of randomization
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
|
Outreach Messaging
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
157
|
|
Overall Study
COMPLETED
|
152
|
113
|
|
Overall Study
NOT COMPLETED
|
0
|
44
|
Reasons for withdrawal
| Measure |
Usual Care
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
|
Outreach Messaging
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
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.
|
|---|---|---|
|
Overall Study
Did not read message or was not reached via telephone
|
0
|
44
|
Baseline Characteristics
Outreach to Reduce Depression Disparities
Baseline characteristics by cohort
| Measure |
Usual Care
n=152 Participants
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
|
Outreach Messaging
n=157 Participants
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
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.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 19.5 • n=14 Participants
|
49.5 years
STANDARD_DEVIATION 19.3 • n=34 Participants
|
49.7 years
STANDARD_DEVIATION 19.4 • n=69 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=14 Participants
|
109 Participants
n=34 Participants
|
207 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=14 Participants
|
48 Participants
n=34 Participants
|
102 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=14 Participants
|
30 Participants
n=34 Participants
|
67 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=14 Participants
|
21 Participants
n=34 Participants
|
38 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=14 Participants
|
60 Participants
n=34 Participants
|
116 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
9 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
36 Participants
n=14 Participants
|
38 Participants
n=34 Participants
|
74 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
20 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=14 Participants
|
145 Participants
n=34 Participants
|
289 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=14 Participants
|
157 participants
n=34 Participants
|
309 participants
n=69 Participants
|
|
PHQ-9 total score
|
14.5 units on a scale
STANDARD_DEVIATION 4.2 • n=14 Participants
|
13.9 units on a scale
STANDARD_DEVIATION 3.6 • n=34 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 3.9 • n=69 Participants
|
PRIMARY outcome
Timeframe: within 60 days of randomizationDefined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
Outcome measures
| Measure |
Usual Care
n=152 Participants
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
|
Outreach Messaging
n=157 Participants
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
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
|
9 Participants
|
36 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outreach Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vanessa Simiola
Kaiser Permanente, Center for Integrated Health Care Research
Phone: 808-432-7777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place