Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HT94252410714 | Other Grant/Funding Number | Department of Defense |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study purpose is to test the effect of Crisis Response Planning (CRP) when used as the second method of suicide prevention in military service members who are at risk for suicide due to mild traumatic brain injury (mTBI). CRP will be compared to usual treatment. The treatment will be a 30 to 60 minute session to one person at a time either in-person or using telehealth.
The objective of this randomized clinical trial is to evaluate the efficacy of Crisis Response Planning as a secondary suicide prevention intervention among military service members who are at elevated risk for suicide due to their history of a mild traumatic brain injury (mTBI). CRP will be compared to a general review of available crisis resources facilitated by a therapist.
Specific Aims:
Aim 1: Determine the effectiveness of Crisis Response Planning (CRP) versus Treatment as Usual (TAU) on impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.
Aim 2: Understand associations between impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.
Aim 3: Determine if mTBI features (e.g., loss of consciousness duration, total number of lifetime TBIs, injury type) influence treatment outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Crisis Response Planning (CRP) | Experimental | One 30-60-minute session delivered individually using in-person or telehealth format by a trained behavioral health provider. |
|
| Arm 2: Treatment as Usual (TAU) | No Intervention | Participants will receive the standard of care treatment as usual (TAU) from the Intrepid Spirit Center interdisciplinary treatment team that includes nurse practitioners, social workers, neurologists, and psychologists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisis Response Planning | Behavioral | The CRP intervention consists of a single 30-60-minute session. The CRP intervention includes a narrative assessment of the participant's most recent emotional crisis experience in order to understand and facilitate the participants understanding of their suicide mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Hopelessness Scale-5 (BHS-5) | BHS is a self-report measure that assess hopelessness using a dichotomist scoring system (0 or 1).This study will use a 5-item version of the BHS developed by the Military Suicide Research Consortium. The score ranges between 0 and 5 with a higher scores indicated higher levels of hopelessness. A change in score will be reported. | Baseline to 3 months |
| Behavioral Inhibition/Activation System Scale (BIS/BAS Scale) | BIS-BAS scale is a 24-item self-reporting scale for the assessment of BIS and BAS sensitivities. All items are measured on a four-point Likert scale with one indicating strong agreement and four as strong disagreements. BIS sensitivity is measured as a single factor with seven items, and the BAS sensitivity is measured as three subfactors, namely drive, reward responsiveness, and fun seeking, each measured by 4, 5, and 4 items, respectively. The scale also contains four filler items which are not scored. All the items other than two and 22 are reverse scored. A change in score will be reported. | Baseline to 3 months |
| Depressive Symptoms Index-Suicidality Subscale (DSI-SS) | The DSI-SS will be used to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal ideation. Total scores range from 0-12. A change in score will be reported. | Baseline to 3 months |
| Entrapment Scale (ES) | The ES is a 16-item measure utilizes a 5-point Likert scale (0 = not at all like me; 4 = extremely like me) to evaluates both internal and external entrapment. Possible range of scores is from 0-64 with a higher score indicating greater feeling of entrapment. A change in score will be reported. | Baseline to 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Tyler, PhD | Contact | (254) 423-8830 | TylerH@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hannah Tyler, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R. Darnall Army Medical Center | Fort Hood | Texas | 76544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29512832 | Background | Bryan CJ. A Preliminary Validation Study of Two Ultra-Brief Measures of Suicide Risk: The Suicide and Perceived Burdensomeness Visual Analog Scales. Suicide Life Threat Behav. 2019 Apr;49(2):343-352. doi: 10.1111/sltb.12447. Epub 2018 Mar 7. | |
| 16223625 | Background | Di Benedetto M, Lindner H, Hare DL, Kent S. A Cardiac Depression Visual Analogue Scale for the brief and rapid assessment of depression following acute coronary syndromes. J Psychosom Res. 2005 Oct;59(4):223-9. doi: 10.1016/j.jpsychores.2005.06.070. |
Not provided
Not provided
As a STRONG STAR study, presentations and publications produced as a result of this work will follow the STRONG STAR Standard Operating Procedure STRONG STAR-ADM-001-5.0: Review and Approval of Publications and Presentation and the International Committee of Medical Journal Editors (ICMJE) "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals" updated January 2024.
After study completion and data are analyzed in a peer review journal and on ClinicalTrials.gov
Not provided
Not provided
Not provided
Two-armed randomized clinical trial
Not provided
Not provided
Because participants, interventionalists, and study staff cannot be blind to the behavioral therapies being delivered, only the independent evaluators will be blind to the treatment condition.
|
|
| Interpersonal Needs Questionnaire-5 (INQ-5) | The INQ is a self-report measure that assesses perceived burdensomeness and thwarted belongingness. This study will use a 5-item version of the INQ developed by the Military Suicide Research Consortium that showed an excellent internal consistency. Items are scored using a rating scale of 1-7 where 1=Not at all true for me to 7=Very true form me. Possible scores range from 5-35, with a higher score indicating better interpersonal relationships. A change in score will be reported. | Baseline to 3 months |
| Monetary Choice Questionnaire (MCQ) | The MCQ is a 27-item, selfadministered questionnaire. For each item, the participant chooses between a smaller, immediate monetary reward and a larger, delayed monetary reward (e.g., "Would you prefer $54 today or $80 in 30 days?"). The protocol is scored by calculating where the respondent's answers place them amid reference discounting curves, with steeper curves indicating higher levels of impulsivity. A change in score will be reported. | Baseline to 3 months |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a 9-item self-report measure of the severity of depressive symptoms. Scores on the PHQ-9 have demonstrated high internal consistency and convergent validity. Items are scored from 0=Not at all to 3=Nearly every day. Total scores range from 0-27 with a higher score indicating less feeling of well-being. A change in score will be reported. | Baseline to 3 months |
| Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R_Bryan) | The SITBI-R is a structured interview assessing the presence, frequency, and characteristics of self-injurious and suicidal thoughts and behaviors. The SITBI-R has high interrater reliability, strong test-retest reliability (Fox et al., 2020; Gratch et al., 2021). The SITBI-R was developed from the SITBI which also demonstrated strong psychometric properties (Nock et al., 2007). We will use the SITBI-R to measure the incidence of suicide attempts and non-suicidal self-injury. | Baseline to 3 months |
| Suicide Cognitions Scale-Revised (SCS-R) | The SCS-R is a 16-item, self-report with each item scored between 0=Strongly disagree to 4=Strongly Agree. Total range of score is between 0-64 with a higher score indicating a higher level of suicidal cognition. measure that assesses suicide-specific thoughts and belief. The scale has demonstrated good internal consistency, convergent validity, and divergent validity (Bryan et al., 2014). The SCS-R evaluates how much an individual agrees with the suicide-related cognition. A change in score will be reported. | Baseline to 3 months |
| Temporal Experience of Pleasure Scale (TEPS) | The TEPS is a 18-item self-report measure designed to assess participants' experience of positive affect using a Likert Scale from 1 (Very false for me) to 6 (Very true for me). The TEPS has strong reliability, high test-retest reliability, as well as good convergency and discriminant validity. Total possible range of score is 18-72, with a higher score indicating greater level of temporal experience of pleasure.A change in score will be reported. | Baseline to 3 months |
| Suicide - Visual Analog Scale (S-VAS). | A visual analog scales with scores range from 0-100 with higher scores reflecting the higher intensity of the item being assessed (urge to die by suicide) at the moment of assessment. A change in score will be reported. | Baseline to 3 months |
| Perceived Burdensomeness - Visual Analog Scale, PB-VAS | A visual analog scale with scores ranging from 0-100 with higher scores reflecting the higher intensity of the item being assessed (perceived burdensomeness) at the moment of assessment. A change in score will be reported. | Baseline to 3 months |
| Hopelessness - Visual Analog Scale (H-VAS) | A visual analog scale with scores ranging from 0-100 with higher scores reflecting the higher intensity of the item being assessed (hopelessness) at the moment of assessment. A change in score will be reported. | Baseline to 3 months |
| 31531784 | Background | Huang Z, Kohler IV, Kampfen F. A Single-Item Visual Analogue Scale (VAS) Measure for Assessing Depression Among College Students. Community Ment Health J. 2020 Feb;56(2):355-367. doi: 10.1007/s10597-019-00469-7. Epub 2019 Sep 17. |
| 15290703 | Background | Kertzman S, Aladjem Z, Milo R, Ben-Nahum Z, Birger M, Grinspan H, Weizman A, Kotler M. The utility of the Visual Analogue Scale for the assessment of depressive mood in cognitively impaired patients. Int J Geriatr Psychiatry. 2004 Aug;19(8):789-96. doi: 10.1002/gps.1141. |
| 24679384 | Background | Bryan CJ, David Rudd M, Wertenberger E, Etienne N, Ray-Sannerud BN, Morrow CE, Peterson AL, Young-McCaughon S. Improving the detection and prediction of suicidal behavior among military personnel by measuring suicidal beliefs: an evaluation of the Suicide Cognitions Scale. J Affect Disord. 2014 Apr;159:15-22. doi: 10.1016/j.jad.2014.02.021. Epub 2014 Feb 19. |
| 17845122 | Background | Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309. |
| 33847199 | Background | Gratch I, Fernandes SN, Bell KA, Pollak OH, Fox KR, Tezanos K, Ebo T, Cha CB. Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R): Reliability, Validity, and Inter-Informant Agreement in an Adolescent Sample. J Clin Child Adolesc Psychol. 2022 Jul-Aug;51(4):484-494. doi: 10.1080/15374416.2021.1901229. Epub 2021 Apr 13. |
| 32324021 | Background | Fox KR, Harris JA, Wang SB, Millner AJ, Deming CA, Nock MK. Self-Injurious Thoughts and Behaviors Interview-Revised: Development, reliability, and validity. Psychol Assess. 2020 Jul;32(7):677-689. doi: 10.1037/pas0000819. Epub 2020 Apr 23. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000092864 | Suicide Prevention |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided