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Brief Skills Training Intervention for Suicidal Individuals

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ClinicalTrials.gov Identifier: NCT02236325
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Erin Ward-Ciesielski, University of Washington

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE September 10, 2014
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
  • Scale for Suicidal Ideation [ Time Frame: 12-weeks of follow-up ]
  • Difficulties in Emotion Regulation Scale [ Time Frame: 12-weeks of follow-up ]
  • DBT Ways of Coping Scale [ Time Frame: 12-weeks of follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
  • Patient Health Questionnaire - Depression Module [ Time Frame: 12-weeks of follow-up ]
  • Beck Anxiety Inventory [ Time Frame: 12-weeks of follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Skills Training Intervention for Suicidal Individuals
Official Title  ICMJE Brief Skills Training Intervention for Suicidal Individuals
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Suicide
Intervention  ICMJE
  • Behavioral: DBT Brief Suicide Intervention
    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.
  • Behavioral: Relaxation Training
    Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.
Study Arms  ICMJE
  • Experimental: DBT Brief Suicide Intervention
    Intervention: Behavioral: DBT Brief Suicide Intervention
  • Active Comparator: Relaxation Training
    Intervention: Behavioral: Relaxation Training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2014)
93
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236325
Other Study ID Numbers  ICMJE 40846-G
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin Ward-Ciesielski, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin Ward-Ciesielski, M.S. University of Washington
PRS Account University of Washington
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP