Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

Not Applicable

Completed

• Conditions: Suicidal and Self-injurious Behavior; Suicidal Ideation Active
• Interventions: Behavioral: Enhanced Care as Usual; Behavioral: The Collaborative Assessment and Management of Suicidality

• Registration Number: NCT01300169
• Lead Sponsor: The Catholic University of America

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 Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Study Start: 2011-03
• Primary Completion: 2017-03-15
• Study Completion: 2017-03-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced Care as Usual--E-CAU	Enhanced Care as Usual	This control group treatment will reflect current clinical practices for treating suicidal soldiers in the research site setting. These are providers were on site clinicians who provided care according to their usual and customary practices for working with suicidal risk within outpatient care.
CAMS--Collaborative Driver-Treatment	The Collaborative Assessment and Management of Suicidality	The Collaborative Assessment and Management of Suicidality (CAMS) is a suicide-specific clinical intervention that targets and treats patient-defined suicidal "drivers" over the course of clinical care.

Primary Outcome Measures

Name	Time	Method
Scale for Suicidal Ideation	Baseline, post-treatment, 1, 3, 6, 12 months	Industry standard for self-report suicidal ideation

Secondary Outcome Measures

Name	Time	Method
Overall symptom distress	Baseline, post treatment, 1, 3, 6, 12 months	Outcome Questionnaire-45