Borderline Personality DisorderPhase 1NCT01343550
Creativity Group for Borderline Personality Disorder
A Phase 1 study testing creativity group in people with Borderline Personality Disorder, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- creativity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- participant self-reports clinical diagnosis of Borderline Personality Disorder
- currently seeing an individual therapist on a regular basis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety.
- Conditions
- Borderline Personality Disorder
- Being tested
- creativity group
- Keywords
- Borderline Personality Disorder, Borderline Personality, Borderline
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creativity groupOther
This is a creativity group intervention. There will be 4 groups. Each group has one session per week. Each session is a duration of two hours.
| Study group | Role | What they receive |
|---|---|---|
| Creativity group for persons diagnosed with BPD | Experimental | Not described Receives: Other: creativity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borderline Evaluation of Severity Over Time (BEST)
Measured: baseline, 5th week, post-intervention (week 8)
Secondary outcomes (1)
Beck Depression Inventory (BDI)
Measured: baseline, week 5, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Blake Bazel, M.S., Study director, State University of New York - Upstate Medical UniversityRobbi Saletsky, Ph.D., Study director, State University of New York - Upstate Medical UniversityRoger Greenberg, Ph.D., Study director, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343550
- Sponsor's protocol ID
- PHS6019
- Status last verified
- Feb 2011
- First submitted
- 26 Apr 2011
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gunderson JG. Borderline personality disorder: ontogeny of a diagnosis. Am J Psychiatry. 2009 May;166(5):530-9. doi: 10.1176/appi.ajp.2009.08121825.
PubMed 19411380Jacob GA, Gabriel S, Roepke S, Stoffers JM, Lieb K, Lammers CH. Group therapy module to enhance self-esteem in patients with borderline personality disorder: a pilot study. Int J Group Psychother. 2010;60(3):373-87. doi: 10.1521/ijgp.2010.60.3.373.
PubMed 20590434
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creativity Group for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01343550
- Acronym / sponsor ID
- PHS6019
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Borderline Personality, Borderline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Apr 2011 (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.
The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creativity group for persons diagnosed with BPD | Experimental | Other: creativity group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- participant self-reports clinical diagnosis of Borderline Personality Disorder
- currently seeing an individual therapist on a regular basis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| creativity groupThis is a creativity group intervention. There will be 4 groups. Each group has one session per week. Each session is a duration of two hours. | Other | Creativity group for persons diagnosed with BPD |
Primary outcome
Borderline Evaluation of Severity Over Time (BEST)
Time frame: baseline, 5th week, post-intervention (week 8)
1 secondary outcome
Beck Depression Inventory (BDI)
Time frame: baseline, week 5, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Background: PubMed 19411380Gunderson JG. Borderline personality disorder: ontogeny of a diagnosis. Am J Psychiatry. 2009 May;166(5):530-9. doi: 10.1176/appi.ajp.2009.08121825.
- Results publication: PubMed 20590434Jacob GA, Gabriel S, Roepke S, Stoffers JM, Lieb K, Lammers CH. Group therapy module to enhance self-esteem in patients with borderline personality disorder: a pilot study. Int J Group Psychother. 2010;60(3):373-87. doi: 10.1521/ijgp.2010.60.3.373.
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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.
Blake Bazel, M.S. study director
State University of New York - Upstate Medical University
Robbi Saletsky, Ph.D. study director
State University of New York - Upstate Medical University
Roger Greenberg, Ph.D. study director
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing creativity group in people with Borderline Personality Disorder, run by State University of New York - Upstate Medical University 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 0 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: finished, as of the sponsor's last update on 20 Oct 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Borderline Evaluation of Severity Over Time (BEST) (time frame: baseline, 5th week, post-intervention (week 8)). 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 NCT01343550, which also lists 2 linked publications.
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 Oct 2021.