Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart (OWL)
This study is currently recruiting participants.
Verified May 2012 by The Catholic University of America
Sponsor:
The Catholic University of America
Collaborators:
University of Washington
Information provided by (Responsible Party):
David A. Jobes, Ph.D., The Catholic University of America
ClinicalTrials.gov Identifier:
NCT01300169
First received: February 17, 2011
Last updated: May 15, 2012
Last verified: May 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 17, 2011 | ||||||||
| Last Updated Date | May 15, 2012 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Scale for Suicidal Ideation [ Time Frame: SSI changes from baseline, to post-treatment, and at 1, 3, 6, 12 months follow up ] [ Designated as safety issue: Yes ] Industry standard for self-report suicidal ideation |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01300169 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Overall symptom distress [ Time Frame: Baseline, post treatment, 1, 3, 6, 12 months ] [ Designated as safety issue: Yes ] Outcome Questionnaire-45 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart | ||||||||
| Official Title ICMJE | A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers | ||||||||
| Brief Summary | This is a randomized clinical trial comparing the use of new psychotherapy intervention (the "Collaborative Assessment and Management of Suicidality--CAMS") versus enhanced care as usual for suicidal Soldiers who are seen at an outpatient mental health clinic at Ft. Stewart GA. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | February 2015 | ||||||||
| Estimated Primary Completion Date | August 2014 (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 |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01300169 | ||||||||
| Other Study ID Numbers ICMJE | CUA-001, 09134002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | David A. Jobes, Ph.D., The Catholic University of America | ||||||||
| Study Sponsor ICMJE | The Catholic University of America | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | The Catholic University of America | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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