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OpenTrials
Completed

NCT Number: NCT01300169

Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

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.

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Key information

Conditions

Suicidal Ideation Active Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal and Self-Injurious Behavior Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Collaborative Assessment and Management of Suicidality

Behavioral

Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.

Enhanced Care as Usual

Behavioral

This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic

Primary outcomes

  1. Scale for Suicidal Ideation

    Time frame: Baseline, post-treatment, 1, 3, 6, 12 months

    Industry standard for self-report suicidal ideation

Secondary outcomes

  1. Overall symptom distress

    Time frame: Baseline, post treatment, 1, 3, 6, 12 months

    Outcome Questionnaire-45

Sponsors and collaborators

Lead sponsor

The Catholic University of America

Other

Collaborators

  • University of Washington
  • VA Office of Research and Development

Registry information

Official study title

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

Acronym: OWL

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 21, 2011
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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