Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicidal Ideation Active, Suicidal and Self-injurious Behavior

Intervention / Treatment
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* Behavioral: The Collaborative Assessment and Management of Suicidality
* Behavioral: Enhanced Care as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMS--Collaborative Driver-Treatment<br>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. | Behavioral: The Collaborative Assessment and Management of Suicidality<br>* Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the drivers of suicidal ideation and behaviors.<br>|
| Active Comparator: Enhanced Care as Usual--E-CAU<br>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. | Behavioral: Enhanced Care as Usual<br>* This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for Suicidal Ideation | Industry standard for self-report suicidal ideation | Baseline, post-treatment, 1, 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall symptom distress | Outcome Questionnaire-45 | Baseline, post treatment, 1, 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Assessment, Intervention, CAMS