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
About this trial
This is an interventional treatment trial for Suicide
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
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
NCT ID
NCT02236325
First Posted
August 27, 2014
Last Updated
September 5, 2014
Sponsor
University of Washington
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
Learn more about this trial
Brief Skills Training Intervention for Suicidal Individuals
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