- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236325
Brief Skills Training Intervention for Suicidal Individuals
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scale for Suicidal Ideation
Time Frame: 12-weeks of follow-up
|
12-weeks of follow-up
|
Difficulties in Emotion Regulation Scale
Time Frame: 12-weeks of follow-up
|
12-weeks of follow-up
|
DBT Ways of Coping Scale
Time Frame: 12-weeks of follow-up
|
12-weeks of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Health Questionnaire - Depression Module
Time Frame: 12-weeks of follow-up
|
12-weeks of follow-up
|
Beck Anxiety Inventory
Time Frame: 12-weeks of follow-up
|
12-weeks of follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin Ward-Ciesielski, M.S., University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40846-G
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
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Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
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Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
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Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityActive, not recruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
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Mental Health Services in the Capital Region, DenmarkCompletedSuicide Prevention | Suicidal Thoughts | Suicide AttemptsDenmark
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VA Office of Research and DevelopmentNot yet recruitingSuicidal Ideation | Suicide Attempt | Suicide PreventionUnited States
-
Franciscan Hospital For Children, INC.National Institute of Mental Health (NIMH); Harvard UniversityRecruitingSuicidal Ideation | Self-Injurious Behavior | Suicide AttemptsUnited States
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Boston UniversityUnited States Department of Defense; The University of Texas Health Science... and other collaboratorsNot yet recruiting
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Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
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University Hospital, MontpellierINSERM U960 - Cognitive Neuroscience Laboratory - Paris, FranceTerminatedDepression | History of Suicide AttemptFrance
Clinical Trials on DBT Brief Suicide Intervention
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VA Office of Research and DevelopmentNot yet recruitingPost-traumatic Stress Disorder (PTSD) | Self-directed ViolenceUnited States
-
University of RochesterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedSuicide, Attempted | Drug Use | Alcohol; Use, ProblemUnited States
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Shanghai Mental Health CenterShanghai Pu Dong Institute of Education Development; Shanghai Sanling North... and other collaboratorsUnknown
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Unity Health TorontoNot yet recruitingTrauma | Suicide | Major Depressive Disorder | PsychotherapyCanada
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University of RochesterNorthwestern University; State University of New York - Upstate Medical University and other collaboratorsActive, not recruiting
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)Completed
-
VA Office of Research and DevelopmentNot yet recruiting
-
University of MinnesotaWithdrawn
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IRCCS Centro San Giovanni di Dio FatebenefratelliCompletedEmotional DysregulationItaly
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University of North Carolina, CharlotteOhio State University; United States Naval Medical Center, PortsmouthRecruitingDepression | PTSD | Anxiety | Suicidal Ideation | Suicide, Attempted | Coping SkillsUnited States