Trial Outcomes & Findings for Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy (NCT NCT02151331)
NCT ID: NCT02151331
Last Updated: 2018-12-12
Results Overview
Mental Health Quality of Life was measured using the 12-Item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
TERMINATED
NA
383 participants
Change from Baseline in Quality of Life at 12-months
2018-12-12
Participant Flow
A total of 383 participants were consented and enrolled to participate. Of those 383 participants, only 169 were randomized participants from a non-responsive site.
Participant milestones
| Measure |
REP + EF
Replication Effective Programs (REP) augmented with External Facilitation (EF)
External Facilitation: Non-responding sites randomized to receive external facilitation
|
REP + EF/IF
Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
92
|
|
Overall Study
COMPLETED
|
45
|
52
|
|
Overall Study
NOT COMPLETED
|
32
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy
Baseline characteristics by cohort
| Measure |
REP + EF
n=77 Participants
Replication Effective Programs (REP) augmented with External Facilitation (EF)
External Facilitation: Non-responding sites randomized to receive external facilitation
|
REP + EF/IF
n=92 Participants
Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 11.19 • n=7 Participants
|
45.38 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
92 participants
n=7 Participants
|
169 participants
n=5 Participants
|
|
Mental Health Quality of Life
|
39.75 units on a scale
STANDARD_DEVIATION 12.92 • n=5 Participants
|
36.66 units on a scale
STANDARD_DEVIATION 13.10 • n=7 Participants
|
38.08 units on a scale
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Mood Disorder Symptoms (PHQ-9)
|
11.45 units on a scale
STANDARD_DEVIATION 6.46 • n=5 Participants
|
12.61 units on a scale
STANDARD_DEVIATION 6.94 • n=7 Participants
|
12.08 units on a scale
STANDARD_DEVIATION 6.73 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in Quality of Life at 12-monthsMental Health Quality of Life was measured using the 12-Item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
Outcome measures
| Measure |
REP + EF
n=45 Participants
Replication Effective Programs (REP) augmented with External Facilitation (EF)
External Facilitation: Non-responding sites randomized to receive external facilitation
|
REP + EF/IF
n=52 Participants
Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation
|
|---|---|---|
|
Health-related Quality of Life - Mental Health Component Score
|
2.14 score on a scale
Interval -0.22 to 4.5
|
-0.20 score on a scale
Interval -3.25 to 0.86
|
PRIMARY outcome
Timeframe: Change from Baseline in Mood Disorder Symptoms at 12-monthsMood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.
Outcome measures
| Measure |
REP + EF
n=45 Participants
Replication Effective Programs (REP) augmented with External Facilitation (EF)
External Facilitation: Non-responding sites randomized to receive external facilitation
|
REP + EF/IF
n=52 Participants
Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
External + Internal Facilitation: Non-responding sites randomized to receive both internal and external facilitation
|
|---|---|---|
|
Reduced Mood Disorder Symptoms
|
-1.57 score on a scale
Interval -2.65 to -0.5
|
-1.02 score on a scale
Interval -2.02 to -0.01
|
SECONDARY outcome
Timeframe: Change from Baseline in Quality of Life at 24-monthsPopulation: No analysis was completed because the funder requested terminating the study due to low enrollment. No data was collected because the study was halted prematurely.
Health-related Quality of Life - Mental Health Component Score of the short form (SF)-12 survey
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline in Mood Disorder Symptoms at 24-monthsPopulation: No analysis was completed because the funder requested terminating the study due to low enrollment. No data was collected because the study was halted prematurely.
Outcome measures
Outcome data not reported
Adverse Events
REP + EF
REP + EF/IF
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