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Brief Skills Training Intervention for Suicidal Individuals

Primary Purpose

Suicide

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DBT Brief Suicide Intervention
Relaxation Training
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18+ years old
  • Suicidal ideation in the last week
  • Live within commuting distance to research office
  • Have not been engaged in mental health treatment in the past month
  • Consent to assessment

Exclusion Criteria:

  • Non-English speaking
  • Significant cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DBT Brief Suicide Intervention

    Relaxation Training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Scale for Suicidal Ideation
    Difficulties in Emotion Regulation Scale
    DBT Ways of Coping Scale

    Secondary Outcome Measures

    Patient Health Questionnaire - Depression Module
    Beck Anxiety Inventory

    Full Information

    First Posted
    August 27, 2014
    Last Updated
    September 5, 2014
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02236325
    Brief Title
    Brief Skills Training Intervention for Suicidal Individuals
    Official Title
    Brief Skills Training Intervention for Suicidal Individuals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    93 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DBT Brief Suicide Intervention
    Arm Type
    Experimental
    Arm Title
    Relaxation Training
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    DBT Brief Suicide Intervention
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation Training
    Intervention Description
    Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.
    Primary Outcome Measure Information:
    Title
    Scale for Suicidal Ideation
    Time Frame
    12-weeks of follow-up
    Title
    Difficulties in Emotion Regulation Scale
    Time Frame
    12-weeks of follow-up
    Title
    DBT Ways of Coping Scale
    Time Frame
    12-weeks of follow-up
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire - Depression Module
    Time Frame
    12-weeks of follow-up
    Title
    Beck Anxiety Inventory
    Time Frame
    12-weeks of follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18+ years old Suicidal ideation in the last week Live within commuting distance to research office Have not been engaged in mental health treatment in the past month Consent to assessment Exclusion Criteria: Non-English speaking Significant cognitive impairment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erin Ward-Ciesielski, M.S.
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27009317
    Citation
    Ward-Ciesielski EF, Jones CB, Wielgus MD, Wilks CR, Linehan MM. Single-session dialectical behavior therapy skills training versus relaxation training for non-treatment-engaged suicidal adults: a randomized controlled trial. BMC Psychol. 2016 Mar 24;4:13. doi: 10.1186/s40359-016-0117-4.
    Results Reference
    derived

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    Brief Skills Training Intervention for Suicidal Individuals

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