Trial Outcomes & Findings for Using Digital Media Advertising to Reduce the Duration of Untreated Psychosis (NCT NCT03975400)
NCT ID: NCT03975400
Last Updated: 2023-11-03
Results Overview
Evaluate the effectiveness of a search engine ad campaign on reducing the duration of untreated psychosis (DUP) by directly comparing DUP pre-campaign to DUP during the campaign.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
698 participants
Primary outcome timeframe
2 years
Results posted on
2023-11-03
Participant Flow
A stepped-wedge cluster randomization design was implemented. OTNY sites were grouped into 6 clusters/regions based on geolocation and the total number of referrals received at each clinic. The six clusters/regions were; 1) Bronx, 2) Manhattan, 3) Queens, 4) Brooklyn, 5) Hudson River/Central NY, 6) Staten Island/Long-Island/Western NY. There was a total of four 6-month time periods, including the baseline period where all 6 clusters receive the control treatment.
Unit of analysis: Regions
Participant milestones
| Measure |
Manhattan and Queens
6 months control: 18 months campaign. After the initial 6-month baseline period, the campaign began running in 2 regions in NYS including Manhattan (4 sites) and Queens (3 sites). The campaign remained active for the entire 18 months.
All other regions/sites remained in the control condition (no campaign).
|
Brooklyn and Hudson Valley/Central NY/Westchester/Middleton
12 months control; 12 months campaign. After 12 months in the control condition, the campaign expanded to another 2 regions including Brooklyn (3 sites), Hudson Valley/Central NY/Westchester/Middleton (6 sites).
All other regions/sites remained in the control condition (no campaign).
|
Bronx and Staten Island/Long Island/Western NY
18 months control; 6 months active campaign. After 18 months in the control condition, the campaign expanded to the final 2 regions including the Bronx (2 sites) and Staten Island/Long Island/Western NY (4 sites).
|
|---|---|---|---|
|
Baseline: Pre-Campaign Activation
STARTED
|
65 2
|
84 2
|
42 2
|
|
Baseline: Pre-Campaign Activation
COMPLETED
|
65 2
|
84 2
|
42 2
|
|
Baseline: Pre-Campaign Activation
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Phase 1 (Active in 2 Regions)
STARTED
|
62 2
|
79 2
|
42 2
|
|
Phase 1 (Active in 2 Regions)
COMPLETED
|
62 2
|
79 2
|
42 2
|
|
Phase 1 (Active in 2 Regions)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Phase 2 (Active in 4 Regions)
STARTED
|
54 2
|
78 2
|
44 2
|
|
Phase 2 (Active in 4 Regions)
COMPLETED
|
54 2
|
78 2
|
44 2
|
|
Phase 2 (Active in 4 Regions)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Phase 3 (Active in All 6 Regions)
STARTED
|
55 2
|
52 2
|
41 2
|
|
Phase 3 (Active in All 6 Regions)
COMPLETED
|
55 2
|
52 2
|
41 2
|
|
Phase 3 (Active in All 6 Regions)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Digital Media Advertising to Reduce the Duration of Untreated Psychosis
Baseline characteristics by cohort
| Measure |
Pre-Campaign
n=356 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation.
|
Active Campaign
n=342 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation.
Search engine advertisement campaign: This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.03 years
STANDARD_DEVIATION 0.13 • n=5 Participants
|
21.26 years
STANDARD_DEVIATION 0.21 • n=7 Participants
|
21.17 years
STANDARD_DEVIATION 0.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
486 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
238 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
151 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsEvaluate the effectiveness of a search engine ad campaign on reducing the duration of untreated psychosis (DUP) by directly comparing DUP pre-campaign to DUP during the campaign.
Outcome measures
| Measure |
Pre-Campaign
n=356 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation.
|
Active Campaign
n=342 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation.
Search engine advertisement campaign: This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.
|
|---|---|---|
|
Reducing the Duration of Untreated Psychosis
|
5.32 Days
Standard Error 0.06
|
5.38 Days
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 2 yearsEvaluate the effectiveness of a search engine ad campaign on rates of referrals by directly comparing referrals pre-campaign to referrals during the campaign.
Outcome measures
| Measure |
Pre-Campaign
n=356 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation.
|
Active Campaign
n=342 Participants
Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation.
Search engine advertisement campaign: This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.
|
|---|---|---|
|
Rates of Referrals
|
86.29 number of new referrals
Standard Deviation 26.10
|
32.10 number of new referrals
Standard Deviation 5.38
|
Adverse Events
Pre-Campaign
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Campaign
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place