Borderline Personality DisorderNCT02522143
College Students Who Self-Harm
A study testing Informational sessions describing BPD characteristics and Condensed-DBT treatment intervention in people with Borderline Personality Disorder and Suicide, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Borderline Personality Disorder, Suicide
- What is being tested?
- Informational sessions describing BPD characteristics and Condensed-DBT treatment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Borderline Personality Disorder, Suicide
- Being tested
- Informational sessions describing BPD characteristics, Condensed-DBT treatment intervention
- Keywords
- self-harm, self-mutilation, cutting
- Medical subject headings
- Borderline Personality Disorder, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational sessions describing BPD characteristicsBehavioural
Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
Condensed-DBT treatment interventionBehavioural
Also called The proposed Condensed-DBT treatment intervention includes all DBT components, tailored to students.
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).
| Study group | Role | What they receive |
|---|---|---|
| Informational Sessions | Sham comparator | Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills Receives: Behavioral: Informational sessions describing BPD characteristics |
| Condensed-DBT treatment intervention | Experimental | Condensed-DBT treatment intervention includes all DBT components, tailored to students. Receives: Behavioral: Condensed-DBT treatment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BPD (Borderline Personality Disorder) behaviors
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,
Measured: 8-weeks
Secondary outcomes (2)
Change in reported psychiatric symptoms,
diminish reported psychiatric symptoms, and Decreased utilization of Emergency Room, crisis, and University Disability Services on campus.
Measured: 8-weeks
Diminished emergency room visits
self reported ER visits
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richelle N Moen,, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522143
- Sponsor's protocol ID
- 1310M45125
- Status last verified
- Jun 2017
- First submitted
- 7 Feb 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- College Students Who Self-Harm: An Intervention Study
- ClinicalTrials.gov ID
- NCT02522143
- Acronym / sponsor ID
- 1310M45125
- Conditions
- Borderline Personality Disorder, Suicide
- Keywords
- self-harm, self-mutilation, cutting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informational Sessions | Sham comparator | Behavioral: Informational sessions describing BPD characteristicsControl intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills |
| Condensed-DBT treatment intervention | Experimental | Behavioral: Condensed-DBT treatment interventionCondensed-DBT treatment intervention includes all DBT components, tailored to students. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational sessions describing BPD characteristicsControl intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills | Behavioural | Informational Sessions |
| Condensed-DBT treatment interventionAlso: The proposed Condensed-DBT treatment intervention includes all DBT components, tailored to students.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). | Behavioural | Condensed-DBT treatment intervention |
Primary outcome
Change in BPD (Borderline Personality Disorder) behaviors
Time frame: 8-weeks
produce greater decreases in depression, anxiety, self-harm, and other BPD behaviors,
2 secondary outcomes
Change in reported psychiatric symptoms,
Time frame: 8-weeks
Diminished emergency room visits
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 33884617Witt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richelle N Moen,, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational sessions describing BPD characteristics and Condensed-DBT treatment intervention in people with Borderline Personality Disorder and Suicide, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BPD (Borderline Personality Disorder) behaviors (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.