<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/NCT02236325</url>
  </required_header>
  <id_info>
    <org_study_id>40846-G</org_study_id>
    <nct_id>NCT02236325</nct_id>
  </id_info>
  <brief_title>Brief Skills Training Intervention for Suicidal Individuals</brief_title>
  <official_title>Brief Skills Training Intervention for Suicidal Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A significant percentage of individuals who die by suicide do not seek mental health services&#xD;
      in the time preceding their death. This population is underserved and it is unclear what&#xD;
      barriers keep them from seeking treatment. In order to begin a line of research aimed at&#xD;
      addressing this high-risk population, this proposal rests on the hypothesis that suicidal&#xD;
      individuals who do not seek treatment prior to attempting suicide experience the same&#xD;
      psychopathological difficulties as suicidal individuals who do seek treatment - namely,&#xD;
      severe emotion dysregulation. However, these non-treatment-seeker s will likely require more&#xD;
      creative recruitment strategies and briefer interventions than treatment-seeking individuals.&#xD;
      As such, this application proposes to use wide-reaching recruitment efforts throughout the&#xD;
      community to locate and enroll individuals who are suicidal but not seeking treatment.&#xD;
      Further, there is a paucity of empirical support for interventions targeting suicidal&#xD;
      individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been&#xD;
      demonstrated to be effective with a suicidal population and is the only treatment whose&#xD;
      effectiveness has been replicated. Previous research has suggested that an abbreviated&#xD;
      version of the skills that are taught in DBT skills training have effectively reduced emotion&#xD;
      dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the&#xD;
      proposed intervention is derived from this evidence-based emotion dysregulation intervention.&#xD;
      As such, the proposed research is a randomized, controlled pilot trial of a very brief,&#xD;
      one-time, skills-based intervention targeting difficulties in emotion regulation and distress&#xD;
      tolerance.&#xD;
&#xD;
      This research aims to evaluate the safety of the intervention, the feasibility of the&#xD;
      research methods (including the appropriateness of the relaxation training control&#xD;
      condition), and to preliminarily estimate the immediate (one week) and long-term (one and&#xD;
      three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a&#xD;
      relaxation training control on the primary outcomes of suicide ideation and emotion&#xD;
      dysregulation as well as a number of secondary outcomes. These results will inform the design&#xD;
      of a subsequent full-scale randomized controlled trial of the DBT-BSI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scale for Suicidal Ideation</measure>
    <time_frame>12-weeks of follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties in Emotion Regulation Scale</measure>
    <time_frame>12-weeks of follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>DBT Ways of Coping Scale</measure>
    <time_frame>12-weeks of follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire - Depression Module</measure>
    <time_frame>12-weeks of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory</measure>
    <time_frame>12-weeks of follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>DBT Brief Suicide Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DBT Brief Suicide Intervention</intervention_name>
    <description>Participants assigned to the DBT Brief Suicide Intervention are presented with a selection of coping strategies selected from the Dialectical Behavior Therapy (DBT) skills training curriculum. The strategies are 1) mindfulness, 2) mindfulness of current emotions, 3) opposite-to-emotion action, 4) distraction, and 5) changing your body chemistry.</description>
    <arm_group_label>DBT Brief Suicide Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation Training</intervention_name>
    <description>Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.</description>
    <arm_group_label>Relaxation Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years old&#xD;
&#xD;
          -  Suicidal ideation in the last week&#xD;
&#xD;
          -  Live within commuting distance to research office&#xD;
&#xD;
          -  Have not been engaged in mental health treatment in the past month&#xD;
&#xD;
          -  Consent to assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Significant cognitive impairment&#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>Erin Ward-Ciesielski, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Erin Ward-Ciesielski</investigator_full_name>
    <investigator_title>Graduate student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <!-- 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/NCT02236325
org study id: 40846-G
nct id: NCT02236325
lead sponsor: 
has dmc: Yes
A significant percentage of individuals who die by suicide do not seek mental health services
      in the time preceding their death. This population is underserved and it is unclear what
      barriers keep them from seeking treatment. In order to begin a line of research aimed at
      addressing this high-risk population, this proposal rests on the hypothesis that suicidal
      individuals who do not seek treatment prior to attempting suicide experience the same
      psychopathological difficulties as suicidal individuals who do seek treatment - namely,
      severe emotion dysregulation. However, these non-treatment-seeker s will likely require more
      creative recruitment strategies and briefer interventions than treatment-seeking individuals.
      As such, this application proposes to use wide-reaching recruitment efforts throughout the
      community to locate and enroll individuals who are suicidal but not seeking treatment.
      Further, there is a paucity of empirical support for interventions targeting suicidal
      individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been
      demonstrated to be effective with a suicidal population and is the only treatment whose
      effectiveness has been replicated. Previous research has suggested that an abbreviated
      version of the skills that are taught in DBT skills training have effectively reduced emotion
      dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the
      proposed intervention is derived from this evidence-based emotion dysregulation intervention.
      As such, the proposed research is a randomized, controlled pilot trial of a very brief,
      one-time, skills-based intervention targeting difficulties in emotion regulation and distress
      tolerance.

      This research aims to evaluate the safety of the intervention, the feasibility of the
      research methods (including the appropriateness of the relaxation training control
      condition), and to preliminarily estimate the immediate (one week) and long-term (one and
      three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a
      relaxation training control on the primary outcomes of suicide ideation and emotion
      dysregulation as well as a number of secondary outcomes. These results will inform the design
      of a subsequent full-scale randomized controlled trial of the DBT-BSI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Scale for Suicidal Ideation
time frame: 12-weeks of follow-up
measure: Difficulties in Emotion Regulation Scale
time frame: 12-weeks of follow-up
measure: DBT Ways of Coping Scale
time frame: 12-weeks of follow-up
measure: Patient Health Questionnaire - Depression Module
time frame: 12-weeks of follow-up
measure: Beck Anxiety Inventory
time frame: 12-weeks of follow-up
arm group label: DBT Brief Suicide Intervention
arm group type: Experimental
arm group label: Relaxation Training
arm group type: Active Comparator
intervention type: Behavioral
intervention name: DBT Brief Suicide Intervention
description: Participants assigned to the DBT Brief Suicide Intervention are presented with a selection of coping strategies selected from the Dialectical Behavior Therapy (DBT) skills training curriculum. The strategies are 1) mindfulness, 2) mindfulness of current emotions, 3) opposite-to-emotion action, 4) distraction, and 5) changing your body chemistry.
arm group label: DBT Brief Suicide Intervention
intervention type: Behavioral
intervention name: Relaxation Training
description: Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.
arm group label: Relaxation Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erin Ward-Ciesielski, M.S.
role: Principal Investigator
affiliation: University of Washington
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Erin Ward-Ciesielski
investigator title: Graduate student
mesh term: Suicide