Suicidal Ideation, Suicide
Conditions
Keywords
suicide, suicidal ideation, military, veteran, cognitive behavioral therapy, behavioral therapy, psychotherapy, Brief Cognitive Behavioral Therapy (BCBT), Treatement As Usual (TAU)
Brief summary
The primary purpose of this study is to compare the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along with remission of psychiatric diagnoses. Secondary purposes include the prospective investigation of suicide risk factors and warning signs to explore these variables' ability to predict subsequent suicidal behavior following an index attempt.
Detailed description
The research gap in the treatment of suicidality is considerable, particularly with military populations, including those returning from deployment in support of OIF/OEF. Only one randomized clinical trial targeting suicidality has been conducted with a military sample (Rudd et al., 1996). Although time-limited treatment of suicidality is the primary target of the project, additional elements will be explored including prospective investigation of suicide risk factors and warning signs, as well as development of a centralized software assessment/management tracking system for high-risk suicidal individuals. Reference to active duty refers to U.S. military service members that have been activated and deployed as a part of OIF/OEF in accordance with federal orders under Title 10 or 32, Unites States Code. This includes individuals on active duty from the National Guard and Reserve forces. Specific Aim 1: To evaluate the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. It is anticipated that a large percentage of those identified for treatment will include military personnel recently returned from OIF/OEF. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, agitation, and sleep disturbance), along with remission of psychiatric diagnoses. Specific Aim 2: To engage in prospective investigation of suicide risk factors (i.e. psychiatric diagnosis and history, suicidal ideation, intent, anxiety, depression, hopelessness) and warning signs (i.e. agitation, sleep disturbance), exploring their ability to predict subsequent suicidal behavior following onset of suicidality. Specific Aim 3: To explore the effectiveness of B-CBT (versus TAU) for increasing appropriate utilization of and compliance with medical, mental health, and substance abuse treatment, as well as improving psychological and social functioning. Specific Aim 4: To develop a risk management software program for the initial risk assessment, ongoing monitoring and clinical management of high-risk suicidal patients. The software program would provide a mechanism for organizing and tracking clinical risk factors and warning signs for suicide, along with appropriate management and clinical intervention strategies during the treatment process.
Interventions
BEHAVIORALTreatment As Usual (TAU)
Sponsors
University of Memphis
The University of Texas Health Science Center at San Antonio
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active duty military * 18 years or older * Current suicidal ideation with intent to die and/or suicide attempt within past month * Able to complete informed consent procedures
Exclusion criteria
* Psychiatric or medical condition that precludes informed consent or outpatient therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up | 24 months | The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scale for Suicide Ideation (SSI) | 24 months | The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity. |
| Beck Depression Inventory, Second Edition (BDI-II) | 24 months | The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression. |
| Beck Hopelessness Scale (BHS) | 24 months | The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future. |
| Beck Anxiety Inventory | 24 months | The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Structured Clinical Interview for DSM-IV, Axis I and II (SCID) | Intake | The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders. |
| Suicide Intent Scale | 24 months | The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual's intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters' perceptions of the attempt. |
| Interpersonal Needs Questionnaire (INQ) | 24 months | The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness). |
| Suicide Cognitions Scale (SCS) | 24 months | The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness). |
| Post Treatment Health Interview (PTHI) | 24 months | Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review. |
Countries
United States
Participant flow
Recruitment details
Participants were identified during weekly behavioral health treatment team meetings and daily emergency department reports. All soldiers admitted to inpatient psychiatric hospitalization for suicidal ideation or for a suicide attempt from January 2011 to September 2012 were referred upon discharge for determination of eligibility.
Pre-assignment details
30 of 206 referred Soldiers were excluded (15 due to planned move in next 6 months, 15 refused). 24 of 176 consenting to participate were excluded (22 ineligible, 2 dropped before randomization).
Participants by arm
| Arm | Count |
|---|---|
| Brief Cognitive Behavioral Therapy (BCBT) In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT) | 76 |
| Treatment As Usual (TAU) Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU) | 76 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Treatment As Usual (TAU) | Brief Cognitive Behavioral Therapy (BCBT) |
|---|---|---|---|
| Age, Continuous | 27.40 years STANDARD_DEVIATION 6.2 | 27.62 years STANDARD_DEVIATION 621 | 27.18 years STANDARD_DEVIATION 6.25 |
| Beck Anxiety Inventory | 29.30 units on a scale STANDARD_DEVIATION 14.33 | 29.74 units on a scale STANDARD_DEVIATION 13.96 | 28.87 units on a scale STANDARD_DEVIATION 14.78 |
| Beck Depression Inventory, 2nd Edition | 32.73 units on a scale STANDARD_DEVIATION 13.81 | 33.51 units on a scale STANDARD_DEVIATION 13.39 | 31.95 units on a scale STANDARD_DEVIATION 14.26 |
| Beck Hopelessness Scale | 12.80 units on a scale STANDARD_DEVIATION 6.05 | 12.72 units on a scale STANDARD_DEVIATION 6.02 | 12.87 units on a scale STANDARD_DEVIATION 6.12 |
| Beck Scale for Suicide Ideation, Current | 10.95 units on a scale STANDARD_DEVIATION 8.53 | 11.07 units on a scale STANDARD_DEVIATION 8.43 | 10.83 units on a scale STANDARD_DEVIATION 8.67 |
| Beck Scale for Suicide Ideation, Worst | 19.11 units on a scale STANDARD_DEVIATION 8.97 | 19.07 units on a scale STANDARD_DEVIATION 8.69 | 19.16 units on a scale STANDARD_DEVIATION 9.3 |
| Deployment history Multiple (2+) | 65 participants | 35 participants | 30 participants |
| Deployment history None | 28 participants | 10 participants | 18 participants |
| Deployment history One | 59 participants | 31 participants | 28 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 21 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 55 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medications Anticonvulsant | 14 participants | 5 participants | 9 participants |
| Medications Antidepressant | 94 participants | 47 participants | 47 participants |
| Medications Antihypertensive | 27 participants | 16 participants | 11 participants |
| Medications Antipsychotic | 23 participants | 13 participants | 10 participants |
| Medications Anxiolytic | 5 participants | 2 participants | 3 participants |
| Medications Benzodiazepine | 18 participants | 12 participants | 6 participants |
| Medications Muscle relaxer | 8 participants | 2 participants | 6 participants |
| Medications Opioid | 13 participants | 7 participants | 6 participants |
| Medications Opioid antagonis | 4 participants | 1 participants | 3 participants |
| Medications Other | 34 participants | 18 participants | 16 participants |
| Medications Sleep/hypnotic | 26 participants | 14 participants | 12 participants |
| Medications Stimulant | 5 participants | 3 participants | 2 participants |
| Military rank E1-E4 | 111 participants | 51 participants | 60 participants |
| Military rank E5-E6 | 35 participants | 20 participants | 15 participants |
| Military rank E7-E9 | 5 participants | 4 participants | 1 participants |
| Military rank Warrant Officer | 1 participants | 1 participants | 0 participants |
| Prior suicide attempts Multiple (2+) | 58 participants | 23 participants | 35 participants |
| Prior suicide attempts None | 36 participants | 19 participants | 17 participants |
| Prior suicide attempts One | 58 participants | 34 participants | 24 participants |
| Psychiatric diagnosis (SCID) Alcohol dependence | 18 participants | 7 participants | 11 participants |
| Psychiatric diagnosis (SCID) Antisocial personality | 8 participants | 3 participants | 5 participants |
| Psychiatric diagnosis (SCID) Anxiety | 6 participants | 2 participants | 4 participants |
| Psychiatric diagnosis (SCID) Borderline personality | 15 participants | 8 participants | 7 participants |
| Psychiatric diagnosis (SCID) Depressive personality | 14 participants | 5 participants | 9 participants |
| Psychiatric diagnosis (SCID) Major depressive | 118 participants | 63 participants | 55 participants |
| Psychiatric diagnosis (SCID) Panic | 7 participants | 3 participants | 4 participants |
| Psychiatric diagnosis (SCID) Posttraumatic stress | 60 participants | 34 participants | 26 participants |
| Psychiatric diagnosis (SCID) Social phobia | 12 participants | 5 participants | 7 participants |
| Psychiatric diagnosis (SCID) Substance dependence | 20 participants | 7 participants | 13 participants |
| PTSD Checklist, Military Version | 56.27 units on a scale STANDARD_DEVIATION 16.89 | 57.39 units on a scale STANDARD_DEVIATION 15.63 | 55.15 units on a scale STANDARD_DEVIATION 18.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 20 participants | 10 participants | 10 participants |
| Race/Ethnicity, Customized More than one race | 12 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 110 participants | 52 participants | 58 participants |
| Sex: Female, Male Female | 19 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 133 Participants | 69 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 76 |
| serious Total, serious adverse events | 1 / 76 | 1 / 76 |
Outcome results
Primary
Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up
The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).
Time frame: 24 months
Population: intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brief Cognitive Behavioral Therapy (BCBT) | Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up | 13.8 estimated percentage w/ suicide attempt |
| Treatment As Usual (TAU) | Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up | 40.2 estimated percentage w/ suicide attempt |
Comparison: To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.p-value: 0.0295% CI: [0.16, 0.87]Regression, Cox
Secondary
Beck Anxiety Inventory
The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.
Time frame: 24 months
Secondary
Beck Depression Inventory, Second Edition (BDI-II)
The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.
Time frame: 24 months
Secondary
Beck Hopelessness Scale (BHS)
The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.
Time frame: 24 months
Secondary
Scale for Suicide Ideation (SSI)
The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.
Time frame: 24 months
Other Pre-specified
Interpersonal Needs Questionnaire (INQ)
The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).
Time frame: 24 months
Other Pre-specified
Post Treatment Health Interview (PTHI)
Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review.
Time frame: 24 months
Other Pre-specified
Structured Clinical Interview for DSM-IV, Axis I and II (SCID)
The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.
Time frame: Intake
Other Pre-specified
Suicide Cognitions Scale (SCS)
The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).
Time frame: 24 months
Other Pre-specified
Suicide Intent Scale
The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual's intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters' perceptions of the attempt.
Time frame: 24 months