Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brief Skills Training Intervention for Suicidal Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Suicide Behavioral: DBT Brief Suicide Intervention Behavioral: Relaxation Training Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Skills Training Intervention for Suicidal Individuals
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: DBT Brief Suicide Intervention 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.

Active Comparator: Relaxation Training 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.




Primary Outcome Measures :
  1. Scale for Suicidal Ideation [ Time Frame: 12-weeks of follow-up ]
  2. Difficulties in Emotion Regulation Scale [ Time Frame: 12-weeks of follow-up ]
  3. DBT Ways of Coping Scale [ Time Frame: 12-weeks of follow-up ]

Secondary Outcome Measures :
  1. Patient Health Questionnaire - Depression Module [ Time Frame: 12-weeks of follow-up ]
  2. Beck Anxiety Inventory [ Time Frame: 12-weeks of follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236325


Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Erin Ward-Ciesielski, M.S. University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Erin Ward-Ciesielski, Graduate student, University of Washington
ClinicalTrials.gov Identifier: NCT02236325    
Other Study ID Numbers: 40846-G
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicide
Self-Injurious Behavior
Behavioral Symptoms