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Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart (OWL)

Primary Purpose

Suicidal Ideation Active, Suicidal and Self-injurious Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Collaborative Assessment and Management of Suicidality
Enhanced Care as Usual
Sponsored by
The Catholic University of America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation Active focused on measuring Suicide, Assessment, Intervention, CAMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CAMS--Collaborative Driver-Treatment

    Enhanced Care as Usual--E-CAU

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Scale for Suicidal Ideation
    Industry standard for self-report suicidal ideation

    Secondary Outcome Measures

    Overall symptom distress
    Outcome Questionnaire-45

    Full Information

    First Posted
    February 17, 2011
    Last Updated
    May 27, 2017
    Sponsor
    The Catholic University of America
    Collaborators
    University of Washington, VA Office of Research and Development
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01300169
    Brief Title
    Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart
    Acronym
    OWL
    Official Title
    A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 15, 2017 (Actual)
    Study Completion Date
    March 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of America
    Collaborators
    University of Washington, VA Office of Research and Development

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation Active, Suicidal and Self-injurious Behavior
    Keywords
    Suicide, Assessment, Intervention, CAMS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAMS--Collaborative Driver-Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Enhanced Care as Usual--E-CAU
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Collaborative Assessment and Management of Suicidality
    Intervention Description
    Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Care as Usual
    Intervention Description
    This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic
    Primary Outcome Measure Information:
    Title
    Scale for Suicidal Ideation
    Description
    Industry standard for self-report suicidal ideation
    Time Frame
    Baseline, post-treatment, 1, 3, 6, 12 months
    Secondary Outcome Measure Information:
    Title
    Overall symptom distress
    Description
    Outcome Questionnaire-45
    Time Frame
    Baseline, post treatment, 1, 3, 6, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David A. Jobes, Ph.D.
    Organizational Affiliation
    The Catholic University of America
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30291761
    Citation
    Corona CD, Gutierrez PM, Wagner BM, Jobes DA. The psychometric properties of the Collaborative Assessment and Management of Suicidality rating scale. J Clin Psychol. 2019 Jan;75(1):190-201. doi: 10.1002/jclp.22699. Epub 2018 Oct 6.
    Results Reference
    derived
    PubMed Identifier
    29466107
    Citation
    Jobes DA, Comtois KA, Gutierrez PM, Brenner LA, Huh D, Chalker SA, Ruhe G, Kerbrat AH, Atkins DC, Jennings K, Crumlish J, Corona CD, Connor SO, Hendricks KE, Schembari B, Singer B, Crow B. A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality versus Enhanced Care as Usual With Suicidal Soldiers. Psychiatry. 2017 Winter;80(4):339-356. doi: 10.1080/00332747.2017.1354607.
    Results Reference
    derived

    Learn more about this trial

    Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

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