Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-09-1-0569 | Other Grant/Funding Number | Department of Defense |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Memphis | OTHER |
| The University of Texas Health Science Center at San Antonio | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Cognitive Behavioral Therapy (BCBT) | Experimental | 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. |
|
| Treatment As Usual (TAU) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Behavioral Therapy (BCBT) | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intake |
| Suicide Intent Scale |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael D Rudd, PhD, ABPP | National Center for Veterans Studies & The University of Utah | Principal Investigator |
| Craig J Bryan, PsyD, ABPP | National Center for Veterans Studies & The University of Utah | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Carson | Colorado Springs | Colorado | 84105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22858207 | Background | Bryan CJ, Rudd MD, Wertenberger E. Reasons for suicide attempts in a clinical sample of active duty soldiers. J Affect Disord. 2013 Jan 10;144(1-2):148-52. doi: 10.1016/j.jad.2012.06.030. Epub 2012 Aug 1. | |
| 22464944 | Background | Bryan CJ, Rudd MD. Life stressors, emotional distress, and trauma-related thoughts occurring in the 24 h preceding active duty U.S. soldiers' suicide attempts. J Psychiatr Res. 2012 Jul;46(7):843-8. doi: 10.1016/j.jpsychires.2012.03.012. Epub 2012 Apr 1. |
| Label | URL |
|---|---|
| National Center for Veterans Studies | View source |
Not provided
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 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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| 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 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). | intent to treat | Posted | Number | estimated percentage w/ suicide attempt | 24 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide death | Psychiatric disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Bryan | University of Utah | 8015877978 | craig.bryan@utah.edu |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment As Usual (TAU) | Behavioral |
|
|
| 24 months |
| 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. | 24 months |
| 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. | 24 months |
| Beck Anxiety Inventory | The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents. | 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.
| 24 months |
| 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). | 24 months |
| 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). | 24 months |
| Post Treatment Health Interview (PTHI) | Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review. | 24 months |
| 25677353 | Result | Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13. |
| 33884617 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants allowed to select more than one racial identity | Number | participants |
|
| Military rank | Number | participants |
|
| Deployment history | Number | participants |
|
| Prior suicide attempts | Number | participants |
|
| Psychiatric diagnosis (SCID) | Only includes diagnoses occurring in 5% or greater of participants in at least one treatment arm. Determined using Structured Clinical Interview for DSM-IV, Axis I and Axis II. | Number | participants |
|
| Medications | Based on self-report and medical record review | Number | participants |
|
| Beck Scale for Suicide Ideation, Current | The intensity of current (i.e., past week) suicidal ideation was measured using the 19-item self-report Beck Scale for Suicide Ideation. Scores range from 0 to 38, with higher scores indicating more severe thoughts and plans about suicide. | Mean | Standard Deviation | units on a scale |
|
| Beck Scale for Suicide Ideation, Worst | The intensity of the most severe suicidal ideation since the last assessment period was measured using the 19-item self-report Beck Scale for Suicide Ideation, Worst. Scores range from 0 to 38, with higher scores indicating more severe thoughts and plans about suicide. | Mean | Standard Deviation | units on a scale |
|
| Beck Hopelessness Scale | The intensity of hopelessness was measured using the 20-item self-report Beck Hopelessness Scale. Scores range from 0 to 20, with higher scores indicating more severe hopelessness. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory, 2nd Edition | The intensity of depression symptoms was measured using the 21-item self-report Beck Depression Inventory, Second Edition. Scores range from 0 to 63, with higher scores indicating more severe depression. | Mean | Standard Deviation | units on a scale |
|
| Beck Anxiety Inventory | The intensity of physiological anxiety symptoms was measured using the 20-item self-report Beck Anxiety Inventory. Scores range from 0 to 60, with higher scores indicating more severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist, Military Version | The intensity of posttraumatic stress symptoms during the past month was measured using the 17-item self-report PTSD Checklist, Military Version. Scores range from 17 to 85, with higher scores indicating more severe PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
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)
| OG001 | 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) |
|
|
|
| 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. | Not Posted | 24 months | Participants |
| 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. | Not Posted | 24 months | Participants |
| 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. | Not Posted | 24 months | Participants |
| Secondary | Beck Anxiety Inventory | The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents. | Not Posted | 24 months | Participants |
| 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. | Not Posted | Intake | Participants |
| 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. | Not Posted | 24 months | Participants |
| 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). | Not Posted | 24 months | Participants |
| 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). | Not Posted | 24 months | Participants |
| 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. | Not Posted | 24 months | Participants |
| 1 |
| 76 |
| 0 |
| 76 |
| EG001 | 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) | 1 | 76 | 0 | 76 |
Not provided
Not provided