Suicidal Ideation, Suicide
Conditions
Keywords
suicide, suicidal ideation, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, veteran, clinical trial, cognitive behavioral therapy, psychotherapy, crisis, Treatment As Usual (TAU), Crisis Response Plan (CRP), Enhanced Crisis Response Plan (E-CRP)
Brief summary
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: 1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to the standard crisis response plan alone (S-CRP) and treatment as usual (TAU). 2. The standard crisis response plan (S-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to treatment as usual (TAU). 3. Greater ambivalence about suicide and faster recall of reasons for living will mediate the relationship between intervention and reduced risk for suicide attempt during follow-up.
Detailed description
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.
Interventions
BEHAVIORALTreatment As Usual (TAU)
BEHAVIORALStandard Crisis Response Plan (S-CRP)
BEHAVIORALEnhanced Crisis Response Plan (E-CRP)
Sponsors
The University of Texas Health Science Center at San Antonio
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Active duty * 18 years of age or older * Reporting current suicidal ideation with intent to die, or a suicide attempt within the past two weeks * Able to speak and understand the English language * Able to complete the informed consent process
Exclusion criteria
* Severe psychiatric or medical conditions that preclude the ability to provide informed consent or participation in outpatient treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Proportion of Participants With Suicide Attempt | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Scale for Suicide Ideation (BSSI) | 1 month, 3 months, and 6 months | 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. |
| Inpatient Psychiatric Hospitalization Days | 6 months | Mean number of days of inpatient psychiatric hospitalization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | Immediately post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment As Usual (TAU) TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU) | 32 |
| Standard Crisis Response Plan (S-CRP) CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP) | 32 |
| Enhanced Crisis Response Plan (E-CRP) The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP) | 33 |
| Total | 97 |
Baseline characteristics
| Characteristic | Treatment As Usual (TAU) | Standard Crisis Response Plan (S-CRP) | Enhanced Crisis Response Plan (E-CRP) | Total |
|---|---|---|---|---|
| Age, Continuous | 25.4 years STANDARD_DEVIATION 5.3 | 27.0 years STANDARD_DEVIATION 6.9 | 26.0 years STANDARD_DEVIATION 6.8 | 26.1 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 3 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 19 Participants | 23 Participants | 65 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 5 Participants | 21 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 28 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 1 / 33 |
| other Total, other adverse events | 0 / 32 | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 1 / 33 |
Outcome results
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
Time frame: 6 months
Population: all participants enrolled, regardless of dropout or withdrawal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment As Usual (TAU) | Estimated Proportion of Participants With Suicide Attempt | 0.19 estimated proportion of participants |
| Standard Crisis Response Plan (S-CRP) | Estimated Proportion of Participants With Suicide Attempt | 0.03 estimated proportion of participants |
| Enhanced Crisis Response Plan (E-CRP) | Estimated Proportion of Participants With Suicide Attempt | 0.06 estimated proportion of participants |
Comparison: Omnibus test of all three groupsp-value: 0.082Log Rank
Comparison: Planned contrast #1: TAU vs. S-CRP/E-CRPp-value: 0.028Log Rank
Comparison: Planned contrast #1: TAU vs. S-CRP/E-CRPp-value: 0.0495% CI: [0.06, 0.96]Regression, Cox
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.
Time frame: 1 month, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment As Usual (TAU) | Beck Scale for Suicide Ideation (BSSI) | 6 months | 7.3 units on a scale | Standard Error 1.5 |
| Treatment As Usual (TAU) | Beck Scale for Suicide Ideation (BSSI) | 3 months | 5.8 units on a scale | Standard Error 1.5 |
| Treatment As Usual (TAU) | Beck Scale for Suicide Ideation (BSSI) | 1 month | 8.4 units on a scale | Standard Error 1.4 |
| Standard Crisis Response Plan (S-CRP) | Beck Scale for Suicide Ideation (BSSI) | 6 months | 2.5 units on a scale | Standard Error 1.6 |
| Standard Crisis Response Plan (S-CRP) | Beck Scale for Suicide Ideation (BSSI) | 1 month | 5.3 units on a scale | Standard Error 1.4 |
| Standard Crisis Response Plan (S-CRP) | Beck Scale for Suicide Ideation (BSSI) | 3 months | 6.0 units on a scale | Standard Error 1.5 |
| Enhanced Crisis Response Plan (E-CRP) | Beck Scale for Suicide Ideation (BSSI) | 3 months | 3.3 units on a scale | Standard Error 1.6 |
| Enhanced Crisis Response Plan (E-CRP) | Beck Scale for Suicide Ideation (BSSI) | 1 month | 3.5 units on a scale | Standard Error 1.5 |
| Enhanced Crisis Response Plan (E-CRP) | Beck Scale for Suicide Ideation (BSSI) | 6 months | 1.9 units on a scale | Standard Error 1.5 |
Comparison: Omnibus test comparing all three groups.p-value: <0.001Mixed Models Analysis
Comparison: Planned contrast #1: TAU vs. S-CRP/E-CRPp-value: <0.001Mixed Models Analysis
Secondary
Inpatient Psychiatric Hospitalization Days
Mean number of days of inpatient psychiatric hospitalization
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment As Usual (TAU) | Inpatient Psychiatric Hospitalization Days | 2.5 days | Standard Error 0.6 |
| Standard Crisis Response Plan (S-CRP) | Inpatient Psychiatric Hospitalization Days | 0.9 days | Standard Error 0.2 |
| Enhanced Crisis Response Plan (E-CRP) | Inpatient Psychiatric Hospitalization Days | 1.2 days | Standard Error 0.3 |
Comparison: Planned contrast #1: TAU vs. S-CRP/E-CRPp-value: <0.001Mixed Models Analysis
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.
Time frame: Immediately post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment As Usual (TAU) | Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | 6 Participants |
| Standard Crisis Response Plan (S-CRP) | Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | 5 Participants |
| Enhanced Crisis Response Plan (E-CRP) | Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician | 1 Participants |
Comparison: Omnibus test of all groupsp-value: 0.04Chi-squared
Comparison: Planned contrast #2: E-CRP vs. TAU/S-CRPp-value: 0.04595% CI: [0.002, 0.9]Chi-squared