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College Students Who Self-Harm

Primary Purpose

Borderline Personality Disorder, Suicide

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational sessions describing BPD characteristics
Condensed-DBT treatment intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring self-harm, self-mutilation, cutting

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CTSI

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Informational Sessions

Condensed-DBT treatment intervention

Arm Description

Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills

Condensed-DBT treatment intervention includes all DBT components, tailored to students.

Outcomes

Primary Outcome Measures

Change in BPD (Borderline Personality Disorder) behaviors
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,

Secondary Outcome Measures

Change in reported psychiatric symptoms,
diminish reported psychiatric symptoms, and Decreased utilization of Emergency Room, crisis, and University Disability Services on campus.
Diminished emergency room visits
self reported ER visits

Full Information

First Posted
February 7, 2014
Last Updated
June 16, 2017
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02522143
Brief Title
College Students Who Self-Harm
Official Title
College Students Who Self-Harm: An Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Suicide
Keywords
self-harm, self-mutilation, cutting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Informational Sessions
Arm Type
Sham Comparator
Arm Description
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Arm Title
Condensed-DBT treatment intervention
Arm Type
Experimental
Arm Description
Condensed-DBT treatment intervention includes all DBT components, tailored to students.
Intervention Type
Behavioral
Intervention Name(s)
Informational sessions describing BPD characteristics
Intervention Description
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Intervention Type
Behavioral
Intervention Name(s)
Condensed-DBT treatment intervention
Other Intervention Name(s)
The proposed Condensed-DBT treatment intervention includes all DBT components, tailored to students.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in BPD (Borderline Personality Disorder) behaviors
Description
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Change in reported psychiatric symptoms,
Description
diminish reported psychiatric symptoms, and Decreased utilization of Emergency Room, crisis, and University Disability Services on campus.
Time Frame
8-weeks
Title
Diminished emergency room visits
Description
self reported ER visits
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richelle N Moen,, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTSI
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived

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College Students Who Self-Harm

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