Study Stopped
No funding
College Students Who Self-Harm
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedJune 20, 2017
June 1, 2017
10 months
February 7, 2014
June 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in BPD (Borderline Personality Disorder) behaviors
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,
8-weeks
Secondary Outcomes (2)
Change in reported psychiatric symptoms,
8-weeks
Diminished emergency room visits
8 weeks
Study Arms (2)
Informational Sessions
SHAM COMPARATORControl intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Condensed-DBT treatment intervention
EXPERIMENTALCondensed-DBT treatment intervention includes all DBT components, tailored to students.
Interventions
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CTSI
Minneapolis, Minnesota, 55425, United States
Related Publications (1)
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.
PMID: 33884617DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richelle N Moen,, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2014
First Posted
August 13, 2015
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 20, 2017
Record last verified: 2017-06