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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-10-2-0181 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
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The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used crisis interventions delivered as routine care in the mental health triage system: (1) Treatment As Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:
The CRP has been proposed as an alternative to TAU for the short-term management of suicidal patients and is now in widespread use, but has never been empirically tested. The CRP is purported to reduce suicide risk via unique mechanisms that directly suicide risk, notably suicidal ambivalence (i.e., the relative balance between the wish to live and the wish to die) and problem solving. Because suicidal ambivalence has gained support as an active mechanism for reducing suicide risk, the present study will also seek to augment this underlying mechanism by directly engaging the suicidal patient in a discussion about their reasons for living, thereby potentially increasing the potency of the CRP.
The present study therefore entails a component analysis of crisis interventions. As such, we anticipate ordered effects, whereby the S-CRP and E-CRP conditions will show significantly better outcomes than TAU, and E-CRP will demonstrate significantly better outcomes than the standard CRP condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual (TAU) | Active Comparator | TAU includes the following intervention components:
|
|
| Standard Crisis Response Plan (S-CRP) | Experimental | CRP includes the following intervention components:
|
|
| Enhanced Crisis Response Plan (E-CRP) | Experimental | The E-CRP includes the following intervention components:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment As Usual (TAU) | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Proportion of Participants With Suicide Attempt | Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Scale for Suicide Ideation (BSSI) | The BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation. | 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention. | Immediately post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig J Bryan, PsyD, ABPP | National Center for Veterans Studies & The University of Utah | Principal Investigator |
| Tracy A Clemans, PsyD | National Center for Veterans Studies & The University of Utah | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Carson | Colorado Springs | Colorado | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28967323 | Derived | Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2. | |
| 28806894 | Derived |
| Label | URL |
|---|---|
| National Center for Veterans Studies | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment As Usual (TAU) | TAU includes the following intervention components:
Treatment As Usual (TAU) |
| FG001 | Standard Crisis Response Plan (S-CRP) | CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) |
| FG002 | Enhanced Crisis Response Plan (E-CRP) | The E-CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) Enhanced Crisis Response Plan (E-CRP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment As Usual (TAU) | TAU includes the following intervention components:
Treatment As Usual (TAU) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Proportion of Participants With Suicide Attempt | Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent | all participants enrolled, regardless of dropout or withdrawal | Posted | Number | estimated proportion of participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment As Usual (TAU) | TAU includes the following intervention components:
Treatment As Usual (TAU) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death by suicide | Nervous system disorders | Systematic Assessment |
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Staffing changes at the research site resulted in a one year suspension of recruitment by the IRB and the inability to meet planned recruitment goals. In all, 97 participants were enrolled, approximately one-quarter of the original goal (N=360).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Bryan | The University of Utah | 801-587-7978 | craig.bryan@utah.edu |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard Crisis Response Plan (S-CRP) | Behavioral |
|
|
| Enhanced Crisis Response Plan (E-CRP) | Behavioral |
|
|
| Inpatient Psychiatric Hospitalization Days | Mean number of days of inpatient psychiatric hospitalization | 6 months |
| Lowder EM, Rade CB, Desmarais SL. Effectiveness of Mental Health Courts in Reducing Recidivism: A Meta-Analysis. Psychiatr Serv. 2018 Jan 1;69(1):15-22. doi: 10.1176/appi.ps.201700107. Epub 2017 Aug 15. |
| Standard Crisis Response Plan (S-CRP) |
CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) |
| BG002 | Enhanced Crisis Response Plan (E-CRP) | The E-CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) Enhanced Crisis Response Plan (E-CRP) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Standard Crisis Response Plan (S-CRP) | CRP includes the following intervention components:
Standard Crisis Response Plan (S-CRP) Enhanced Crisis Response Plan (E-CRP) |
| OG002 | Enhanced Crisis Response Plan (E-CRP) | The E-CRP includes the following intervention components:
Enhanced Crisis Response Plan (E-CRP) |
|
|
|
| Secondary | Beck Scale for Suicide Ideation (BSSI) | The BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation. | Posted | Mean | Standard Error | units on a scale | 1 month, 3 months, and 6 months |
|
|
|
|
| Secondary | Inpatient Psychiatric Hospitalization Days | Mean number of days of inpatient psychiatric hospitalization | Posted | Mean | Standard Error | days | 6 months |
|
|
|
|
| Other Pre-specified | Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention. | Posted | Count of Participants | Participants | Immediately post-intervention |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Standard Crisis Response Plan (S-CRP) | CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Enhanced Crisis Response Plan (E-CRP) | The E-CRP includes the following intervention components:
Treatment As Usual (TAU) Crisis Response Plan (CRP) Enhanced Crisis Response Plan (E-CRP) | 1 | 33 | 1 | 33 | 0 | 33 |
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|
| 6 months |
|
| <0.001 |
| Superiority |
| 0.045 |
| Odds Ratio (OR) |
| 0.1 |
| 2-Sided |
| 95 |
| 0.002 |
| 0.9 |
| Superiority |