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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Washington
VA Office of Research and Development
Information provided by (Responsible Party):
David A. Jobes, Ph.D., The Catholic University of America
ClinicalTrials.gov Identifier:
NCT01300169
First received: February 17, 2011
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Suicidal Ideation Active
Suicidal and Self-injurious Behavior
Behavioral: The Collaborative Assessment and Management of Suicidality
Behavioral: Enhanced Care as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers

Resource links provided by NLM:


Further study details as provided by The Catholic University of America:

Primary Outcome Measures:
  • Scale for Suicidal Ideation [ Time Frame: Baseline, post-treatment, 1, 3, 6, 12 months ] [ Designated as safety issue: Yes ]
    Industry standard for self-report suicidal ideation


Secondary Outcome Measures:
  • Overall symptom distress [ Time Frame: Baseline, post treatment, 1, 3, 6, 12 months ] [ Designated as safety issue: Yes ]
    Outcome Questionnaire-45


Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAMS--Collaborative Driver-Treatment
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
Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.
Active Comparator: Enhanced Care as Usual--E-CAU
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
This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300169

Sponsors and Collaborators
The Catholic University of America
University of Washington
VA Office of Research and Development
Investigators
Principal Investigator: David A. Jobes, Ph.D. The Catholic University of America
  More Information

Responsible Party: David A. Jobes, Ph.D., Professor of Psychology, The Catholic University of America
ClinicalTrials.gov Identifier: NCT01300169     History of Changes
Other Study ID Numbers: CUA-001  09134002 
Study First Received: February 17, 2011
Last Updated: July 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by The Catholic University of America:
Suicide
Assessment
Intervention
CAMS

Additional relevant MeSH terms:
Suicidal Ideation
Self-Injurious Behavior
Suicide
Behavioral Symptoms

ClinicalTrials.gov processed this record on December 02, 2016