Suicidal Ideation ActiveOWLNCT01300169
Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart
A study testing The Collaborative Assessment and Management of Suicidality and Enhanced Care as Usual in people with Suicidal Ideation Active and Suicidal and Self-injurious Behavior, run by The Catholic University of America.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation Active, Suicidal and Self-injurious Behavior
- What is being tested?
- The Collaborative Assessment and Management of Suicidality and Enhanced Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to 15 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant psychosis, cognitive or physical impairment to not give consent
- Judicially ordered treatments
About this study
Official title: A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers
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.
Read the 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.
- Being tested
- The Collaborative Assessment and Management of Suicidality, Enhanced Care as Usual
- Keywords
- Suicide, Assessment, Intervention, CAMS
- Medical subject headings
- Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Collaborative Assessment and Management of SuicidalityBehavioural
Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.
Enhanced Care as UsualBehavioural
This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| CAMS--Collaborative Driver-Treatment | Experimental | 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. Receives: Behavioral: The Collaborative Assessment and Management of Suicidality |
| Enhanced Care as Usual--E-CAU | Active comparator | 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. Receives: Behavioral: Enhanced Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Suicidal Ideation
Industry standard for self-report suicidal ideation
Measured: Baseline, post-treatment, 1, 3, 6, 12 months
Secondary outcomes (1)
Overall symptom distress
Outcome Questionnaire-45
Measured: Baseline, post treatment, 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal Ideation ActiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of America
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Jobes, Ph.D., The Catholic University of America
- Investigators
- David A. Jobes, Ph.D., Principal investigator, The Catholic University of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300169
- Sponsor's protocol ID
- CUA-001
- Other IDs
- 09134002
- Acronym
- OWL
- Status last verified
- May 2017
- First submitted
- 17 Feb 2011
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lynch T, Bathe VC, Jobes DA. The Content of Patient-Identified Suicidal Drivers within CAMS Treatment Planning. Arch Suicide Res. 2024 Jan-Mar;28(1):411-417. doi: 10.1080/13811118.2022.2151958. Epub 2022 Dec 22.
PubMed 36550770Corona 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.
PubMed 30291761Jobes 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.
PubMed 29466107
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers
- ClinicalTrials.gov ID
- NCT01300169
- Acronym / sponsor ID
- OWL / CUA-001
- Keywords
- Suicide, Assessment, Intervention, CAMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Catholic University of AmericaUniversity, hospital or other
- Collaborators
- University of Washington, VA Office of Research and Development
- Study start
- Mar 2011
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAMS--Collaborative Driver-Treatment | Experimental | Behavioral: The Collaborative Assessment and Management of SuicidalityThe 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. |
| Enhanced Care as Usual--E-CAU | Active comparator | Behavioral: Enhanced Care as UsualThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Significant psychosis, cognitive or physical impairment to not give consent
- Judicially ordered treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Collaborative Assessment and Management of SuicidalityIntensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors. | Behavioural | CAMS--Collaborative Driver-Treatment |
| Enhanced Care as UsualThis is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic | Behavioural | Enhanced Care as Usual--E-CAU |
Primary outcome
Scale for Suicidal Ideation
Time frame: Baseline, post-treatment, 1, 3, 6, 12 months
Industry standard for self-report suicidal ideation
1 secondary outcome
Overall symptom distress
Time frame: Baseline, post treatment, 1, 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 36550770Lynch T, Bathe VC, Jobes DA. The Content of Patient-Identified Suicidal Drivers within CAMS Treatment Planning. Arch Suicide Res. 2024 Jan-Mar;28(1):411-417. doi: 10.1080/13811118.2022.2151958. Epub 2022 Dec 22.
- Derived from this study: PubMed 30291761Corona 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.
- Derived from this study: PubMed 29466107Jobes 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.
- Individual participant dataSharing planned: Undecided
Related trials for Suicidal Ideation Active
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Active, not recruiting
The Group Risk Reduction Intervention Therapy (GRRIT) Project
Suicidal Ideation, Suicide, Attempted
Not yet recruiting
Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation
Suicidal Ideation Active, Depression Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Jobes, Ph.D. principal investigator
The Catholic University of America
Questions about this trial
What is this clinical trial studying?
A study testing The Collaborative Assessment and Management of Suicidality and Enhanced Care as Usual in people with Suicidal Ideation Active and Suicidal and Self-injurious Behavior, run by The Catholic University of America.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicidal Ideation (time frame: Baseline, post-treatment, 1, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01300169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.