College Students Who Self-Harm

June 16, 2017 updated by: University of Minnesota

College Students Who Self-Harm: An Intervention Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55425
        • CTSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 27 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Informational Sessions
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Behavioral: Informational sessions describing BPD characteristics
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Experimental: Condensed-DBT treatment intervention
Condensed-DBT treatment intervention includes all DBT components, tailored to students.
Behavioral: 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).
Other Names:
  • The proposed Condensed-DBT treatment intervention includes all DBT components, tailored to students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BPD (Borderline Personality Disorder) behaviors
Time Frame: 8-weeks
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,
8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reported psychiatric symptoms,
Time Frame: 8-weeks
diminish reported psychiatric symptoms, and Decreased utilization of Emergency Room, crisis, and University Disability Services on campus.
8-weeks
Diminished emergency room visits
Time Frame: 8 weeks
self reported ER visits
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Richelle N Moen,, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 16, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310M45125

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.

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