<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03769259</url>
  </required_header>
  <id_info>
    <org_study_id>NMCCL.2018.0009</org_study_id>
    <secondary_id>W81XWH1820022</secondary_id>
    <nct_id>NCT03769259</nct_id>
  </id_info>
  <brief_title>Brief Cognitive Behavioral Therapy Replication Trial</brief_title>
  <official_title>Brief Cognitive Behavioral Therapy Replication Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal for the proposed project is to test the effectiveness of BCBT for the&#xD;
      prevention of suicide attempts in a sample of treatment-seeking Marines. The standard null&#xD;
      hypothesis will involve tests conducted comparing improvement following BCBT (treatment&#xD;
      duration of 12 weeks) to Person-Centered Therapy (PCT). The primary outcome comparisons will&#xD;
      include direct markers of suicidality (i.e. suicide, suicide attempts). Secondary outcomes&#xD;
      will be suicide ideation and indicators of psychiatric distress (e.g., depression,&#xD;
      hopelessness). We also aim to assess several hypothesized psychological and neurocognitive&#xD;
      mediators of treatment effects (e.g., wish to live, attentional bias, emotion regulation).&#xD;
      Participants will be followed for 2 years posttreatment by independent evaluators blind to&#xD;
      treatment condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of suicides by military personnel has steadily increased since 2004, especially in&#xD;
      the U.S. Marine Corps (USMC), and has remained high despite a relative decline during 2014.&#xD;
      Previous research conducted with active duty Army personnel supports the superiority of BCBT&#xD;
      and its components over treatment as usual for the reduction of suicide attempts. Additional&#xD;
      research is needed to determine if these effects are generalizable to the U.S. Marine Corps&#xD;
      and to confirm hypothesized mechanisms of action. Reference to &quot;active duty&quot; refers to U.S.&#xD;
      military service members that have been activated and deployed as a part of Operation Iraqi&#xD;
      Freedom/Operation Enduring Freedom (OIF/OEF) in accordance with federal orders under Title 10&#xD;
      or 32, United States Code.&#xD;
&#xD;
      Specific Aim 1:To replicate previous findings supporting the efficacy of BCBT for the&#xD;
      prevention of suicide attempts among active duty Marines (regardless of Axis I or II&#xD;
      diagnosis). The standard null hypothesis will involve tests conducted comparing improvement&#xD;
      following BCBT to Present-Centered Therapy (PCT)&#xD;
&#xD;
      Specific Aim 2: To identify cognitive-affective mediators of BCBT's effects on risk for&#xD;
      suicide attempt.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of suicide attempts from baseline</measure>
    <time_frame>Assessed every 3 months through study completion (average of 2 years)</time_frame>
    <description>The change in number of suicide attempts from baseline will be assessed through review of participants' medical records and through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in suicidal ideation scores from baseline</measure>
    <time_frame>Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)</time_frame>
    <description>The Beck Scale for Suicide Ideation is a 21-item self-report measure of the severity of current suicidal ideation. Items 1-19 measure current suicidal ideation, with summed total scores for these items ranging from 0-38. Higher scores are associated with more severe suicidal ideation and are considered a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Suicide, Attempted</condition>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>Brief Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Present-Centered Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Cognitive Behavioral Therapy (BCBT)</intervention_name>
    <description>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.</description>
    <arm_group_label>Brief Cognitive Behavioral Therapy</arm_group_label>
    <other_name>Cognitive Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Present-Centered Therapy (PCT)</intervention_name>
    <description>Participants in PCT will receive will include 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. PCT consists of (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors among military personnel; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions.</description>
    <arm_group_label>Present-Centered Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual (TAU)</intervention_name>
    <description>All participants will receive the following interventions or procedures, regardless of treatment assignment:&#xD;
Suicide risk assessment using the Columbia Suicide Severity Rating Scale&#xD;
VA's safety planning intervention, which include Military Crisis Line contact information and lethal means access reduction&#xD;
Caring contacts and outreach via the Marine Intercept Program (MIP)&#xD;
Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual</description>
    <arm_group_label>Brief Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_label>Present-Centered Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty Marine&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Reporting current suicide ideation with intent to die and/or a suicide attempt within&#xD;
             the past two weeks&#xD;
&#xD;
          -  Ability to understand and speak the English language; and ability to complete the&#xD;
             informed consent process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or medical condition that precludes the ability to provide informed&#xD;
             consent or participation in outpatient treatment (e.g., psychosis, mania, acute&#xD;
             intoxication).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig J Bryan, PsyD, ABPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Veterans Studies &amp; the University of Utah</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LT Justin Baker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naval Medical Center Camp Lejeune</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center Camp Lejeune</name>
      <address>
        <city>Jacksonville</city>
        <state>North Carolina</state>
        <zip>28547</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://veterans.utah.edu</url>
    <description>National Center for Veterans Studies</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>22858207</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22464944</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25677353</PMID>
  </reference>
  <reference>
    <citation>Bryan CJ, Mintz J, Clemans TA, Leeson B, Burch TS, Williams SR, Maney E, Rudd MD. Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. J Affect Disord. 2017 Apr 1;212:64-72. doi: 10.1016/j.jad.2017.01.028. Epub 2017 Jan 23.</citation>
    <PMID>28142085</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Craig Bryan</investigator_full_name>
    <investigator_title>Executive Director, National Center for Veterans Studies</investigator_title>
  </responsible_party>
  <keyword>suicide</keyword>
  <keyword>suicidal ideation</keyword>
  <keyword>ambivalence</keyword>
  <keyword>suicide ambivalence</keyword>
  <keyword>reasons for living</keyword>
  <keyword>reasons for dying</keyword>
  <keyword>military</keyword>
  <keyword>clinical trial</keyword>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>psychotherapy</keyword>
  <keyword>crisis</keyword>
  <keyword>Crisis Response Plan (CRP)</keyword>
  <keyword>Present Centered Therapy (PCT)</keyword>
  <keyword>Brief Cognitive-Behavioral Therapy (BCBT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03769259/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03769259
org study id: NMCCL.2018.0009
secondary id: W81XWH1820022
nct id: NCT03769259
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall goal for the proposed project is to test the effectiveness of BCBT for the
      prevention of suicide attempts in a sample of treatment-seeking Marines. The standard null
      hypothesis will involve tests conducted comparing improvement following BCBT (treatment
      duration of 12 weeks) to Person-Centered Therapy (PCT). The primary outcome comparisons will
      include direct markers of suicidality (i.e. suicide, suicide attempts). Secondary outcomes
      will be suicide ideation and indicators of psychiatric distress (e.g., depression,
      hopelessness). We also aim to assess several hypothesized psychological and neurocognitive
      mediators of treatment effects (e.g., wish to live, attentional bias, emotion regulation).
      Participants will be followed for 2 years posttreatment by independent evaluators blind to
      treatment condition.
The number of suicides by military personnel has steadily increased since 2004, especially in
      the U.S. Marine Corps (USMC), and has remained high despite a relative decline during 2014.
      Previous research conducted with active duty Army personnel supports the superiority of BCBT
      and its components over treatment as usual for the reduction of suicide attempts. Additional
      research is needed to determine if these effects are generalizable to the U.S. Marine Corps
      and to confirm hypothesized mechanisms of action. Reference to "active duty" refers to U.S.
      military service members that have been activated and deployed as a part of Operation Iraqi
      Freedom/Operation Enduring Freedom (OIF/OEF) in accordance with federal orders under Title 10
      or 32, United States Code.

      Specific Aim 1:To replicate previous findings supporting the efficacy of BCBT for the
      prevention of suicide attempts among active duty Marines (regardless of Axis I or II
      diagnosis). The standard null hypothesis will involve tests conducted comparing improvement
      following BCBT to Present-Centered Therapy (PCT)

      Specific Aim 2: To identify cognitive-affective mediators of BCBT's effects on risk for
      suicide attempt.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in number of suicide attempts from baseline
time frame: Assessed every 3 months through study completion (average of 2 years)
description: The change in number of suicide attempts from baseline will be assessed through review of participants' medical records and through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.
measure: Change in suicidal ideation scores from baseline
time frame: Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)
description: The Beck Scale for Suicide Ideation is a 21-item self-report measure of the severity of current suicidal ideation. Items 1-19 measure current suicidal ideation, with summed total scores for these items ranging from 0-38. Higher scores are associated with more severe suicidal ideation and are considered a worse outcome.
arm group label: Brief Cognitive Behavioral Therapy
arm group type: Experimental
arm group label: Present-Centered Therapy
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Brief Cognitive Behavioral Therapy (BCBT)
description: 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.
arm group label: Brief Cognitive Behavioral Therapy
other name: Cognitive Therapy
intervention type: Behavioral
intervention name: Present-Centered Therapy (PCT)
description: Participants in PCT will receive will include 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. PCT consists of (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors among military personnel; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions.
arm group label: Present-Centered Therapy
intervention type: Behavioral
intervention name: Treatment as Usual (TAU)
description: All participants will receive the following interventions or procedures, regardless of treatment assignment:
Suicide risk assessment using the Columbia Suicide Severity Rating Scale
VA's safety planning intervention, which include Military Crisis Line contact information and lethal means access reduction
Caring contacts and outreach via the Marine Intercept Program (MIP)
Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual
arm group label: Brief Cognitive Behavioral Therapy
arm group label: Present-Centered Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Craig J Bryan, PsyD, ABPP
role: Principal Investigator
affiliation: National Center for Veterans Studies & the University of Utah
last name: LT Justin Baker, PhD
role: Principal Investigator
affiliation: Naval Medical Center Camp Lejeune
facility: 
country: United States
url: http://veterans.utah.edu
description: National Center for Veterans Studies
citation: 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.
PMID: 22858207
citation: 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.
PMID: 22464944
citation: 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.
PMID: 25677353
citation: Bryan CJ, Mintz J, Clemans TA, Leeson B, Burch TS, Williams SR, Maney E, Rudd MD. Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. J Affect Disord. 2017 Apr 1;212:64-72. doi: 10.1016/j.jad.2017.01.028. Epub 2017 Jan 23.
PMID: 28142085
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Craig Bryan
investigator title: Executive Director, National Center for Veterans Studies
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Suicide, Attempted
provided document: 