Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

Suicidal and Self-injurious Behavior Clinical Trial

— OWL  

Official title:

A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300169
• Other study ID #: CUA-001
• Secondary ID: 09134002
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: May 27, 2017
• Start date: March 2011
• Est. completion date: March 15, 2017

Study information

• Verified date: May 2017
• Source: The Catholic University of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Active duty Army personnel at FSGA

• Significant suicidal ideation

• Soldier is appropriate under FSGA policies

• Consent at baseline and follow up

• Consent to randomization and being digitally recorded

Exclusion Criteria:

• Significant psychosis, cognitive or physical impairment to not give consent

• Judicially ordered treatments

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal and Self-injurious Behavior
• Suicidal Ideation
• Suicidal Ideation Active

Intervention

Behavioral:
• The Collaborative Assessment and Management of Suicidality
Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.
• Enhanced Care as Usual
This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Catholic University of America	University of Washington, VA Office of Research and Development

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for Suicidal Ideation	Industry standard for self-report suicidal ideation	Baseline, post-treatment, 1, 3, 6, 12 months
Secondary	Overall symptom distress	Outcome Questionnaire-45	Baseline, post treatment, 1, 3, 6, 12 months