Working Toward Wellness (WtW)
Tracking Information | |||||
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First Received Date ICMJE | June 5, 2008 | ||||
Last Updated Date | March 23, 2012 | ||||
Start Date ICMJE | October 2004 | ||||
Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Use of mental health services [ Time Frame: Through 36 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00694681 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Depression severity [ Time Frame: 6, 18, and 36 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Working Toward Wellness | ||||
Official Title ICMJE | Enhanced Services for the Hard to Employ Demonstration: Telephonic Care Management for Depressed Medicaid Recipients | ||||
Brief Summary | Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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Condition ICMJE | Depression | ||||
Intervention ICMJE | Behavioral: Telephonic care management
Individuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone. |
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Study Arm (s) | |||||
Publications * | Kim SE, Le Blanc AJ, Michalopoulos C, Azocar F, Ludman EJ, Butler DM, Simon GE. Does telephone care management help Medicaid beneficiaries with depression? Am J Manag Care. 2011 Oct 1;17(10):e375-82. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 499 | ||||
Completion Date | September 2011 | ||||
Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00694681 | ||||
Other Study ID Numbers ICMJE | HHS-233-01-0012-RI | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Charles Michalopoulos, MDRC | ||||
Study Sponsor ICMJE | MDRC | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | MDRC | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |