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Trial record 1 of 1 for:    NCT02151331
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Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151331
Recruitment Status : Terminated (Sponsor requested termination due to low recruitment numbers)
First Posted : May 30, 2014
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy M. Kilbourne, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Bipolar Disorder
Depression
Mood Disorder
Interventions Behavioral: External Facilitation
Behavioral: External + Internal Facilitation
Enrollment 383
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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

Period Title: Overall Study
Started 77 92
Completed 45 52
Not Completed 32 40
Arm/Group Title REP + EF REP + EF/IF Total
Hide Arm/Group Description

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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 of all reporting groups
Overall Number of Baseline Participants 77 92 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 92 participants 169 participants
48.2  (11.14) 43.0  (11.19) 45.38  (11.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 92 participants 169 participants
Female
54
  70.1%
71
  77.2%
125
  74.0%
Male
23
  29.9%
21
  22.8%
44
  26.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 92 participants 169 participants
White
61
  79.2%
73
  79.3%
134
  79.3%
Not Available
16
  20.8%
19
  20.7%
35
  20.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 92 participants 169 participants
77 92 169
Mental Health Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 77 participants 92 participants 169 participants
39.75  (12.92) 36.66  (13.10) 38.08  (13.07)
[1]
Measure Description: 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.
Mood Disorder Symptoms (PHQ-9)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 77 participants 92 participants 169 participants
11.45  (6.46) 12.61  (6.94) 12.08  (6.73)
[1]
Measure Description: Mood 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.
1.Primary Outcome
Title Health-related Quality of Life - Mental Health Component Score
Hide Description 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.
Time Frame Change from Baseline in Quality of Life at 12-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description:

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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 Number of Participants Analyzed 45 52
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.14
(-0.22 to 4.50)
-0.20
(-3.25 to 0.86)
2.Primary Outcome
Title Reduced Mood Disorder Symptoms
Hide Description Mood 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.
Time Frame Change from Baseline in Mood Disorder Symptoms at 12-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description:

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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 Number of Participants Analyzed 45 52
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-1.57
(-2.65 to -0.50)
-1.02
(-2.02 to -0.01)
3.Secondary Outcome
Title Health-related Quality of Life - Mental Health Component Score
Hide Description Health-related Quality of Life - Mental Health Component Score of the short form (SF)-12 survey
Time Frame Change from Baseline in Quality of Life at 24-months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description:

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Reduced Mood Disorder Symptoms
Hide Description [Not Specified]
Time Frame Change from Baseline in Mood Disorder Symptoms at 24-months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description:

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events data were collected over an 18-month period
Adverse Event Reporting Description No adverse events were reported for this study
 
Arm/Group Title REP + EF REP + EF/IF
Hide Arm/Group Description

Replication Effective Programs (REP) augmented with External Facilitation (EF)

External Facilitation: Non-responding sites randomized to receive external facilitation

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

All-Cause Mortality
REP + EF REP + EF/IF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/92 (0.00%) 
Hide Serious Adverse Events
REP + EF REP + EF/IF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/92 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
REP + EF REP + EF/IF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/92 (0.00%) 
Number of patients referred for study was much lower than anticipated; many sites participating in the study (N=18) did not refer any patients and therefore are not included in patient-level outcomes analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy Kilbourne, PhD
Organization: University of Michigan
Phone: 734-845-3452
EMail: amykilbo@umich.edu
Layout table for additonal information
Responsible Party: Amy M. Kilbourne, University of Michigan
ClinicalTrials.gov Identifier: NCT02151331    
Other Study ID Numbers: 1R01MH099898-01A1 ( U.S. NIH Grant/Contract )
1R01MH099898-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 28, 2014
First Posted: May 30, 2014
Results First Submitted: October 15, 2018
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018