College Students Who Self-Harm

Suicide Clinical Trial

Official title:

College Students Who Self-Harm: An Intervention Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02522143
• Other study ID #: 1310M45125
• Status: Withdrawn
• Phase: N/A
• First received: February 7, 2014
• Last updated: June 16, 2017
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.

Description:

Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD with its associated high rate of self-harm and suicide. The investigator previously implemented a 4-mth condensed-DBT regimen with success in an adult clinical population. This study will evaluate an intensive 8 week intervention formulated for students to reduce the high prevalence of self-harm and dysfunctional behavior in this population and reduce the need for extended treatment in later years. It will include rigorous screening for collateral disorders, including Substance Use Disorders exacerbating BPD symptoms and suicide risk.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

Inclusion Criteria:

• Age 18 to 27

• Currently enrolled in college

• Meet at least 4 of 9 Criteria of BPD (DSM-V) with one criterion being self-harm (e.g. cut, burn, or hit self)

Exclusion Criteria:

• have a current major psychiatric disorder diagnosis, or other gross cognitive impairment (as identified in the phone screen or the SCID I measure) or

• have undergone DBT or

• are suicidal and require full DBT and/or hospitalization or

• are currently in any other individual or group therapy

• unable to attend weekly visits over 8 weeks, starting March 24, 2014

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Suicide

Intervention

Behavioral:
• Informational sessions describing BPD characteristics
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
• Condensed-DBT treatment intervention
The Intervention consists of an 8-week manual based psychoeducational group utilizing modified condensed-DBT Treatment manual previously used in a treatment study (Moen et al, 2012).

Locations

Country	Name	City	State
United States	CTSI	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BPD (Borderline Personality Disorder) behaviors	produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,	8-weeks
Secondary	Change in reported psychiatric symptoms,	diminish reported psychiatric symptoms, and Decreased utilization of Emergency Room, crisis, and University Disability Services on campus.	8-weeks
Secondary	Diminished emergency room visits	self reported ER visits	8 weeks