Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT01300169
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2011-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart
Sponsor:
The Catholic University of America
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OWL
Brief Summary:
This is a randomized controlled trial comparing the use of new clinical intervention (the "Collaborative Assessment and Management of Suicidality--CAMS") versus enhanced care as usual for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.
Detailed Description:
This is a randomized controlled clinical trial of 148 suicidal active-duty US Army Soldiers. Participants were randomized to on-site providers who were trained in the Collaborative Assessment and Management of Suicidality (CAMS) vs. providers doing their own routine care--referred to as Enhanced Care as Usual (E-CAU) within an outpatient military treatment center. The CAMS Rating Scale (CRS) was used to reliably verify fidelity between treatment conditions and the adherence by CAMS providers to the model. Participants received informed consent to be randomly assigned to treatment arm and were ask to complete study assessments at baseline, 3 months, 6 months, and 12 months after the start of treatment. Recruitment is complete and all study assessments were completed as of March 2016. The study is in a second year of no cost extension; outcome data analyses and moderator analyses are currently underway to develop manuscripts for submission to peer-review scientific journals.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 09134002 | OTHER_GRANT | Department of Defense | View |