Borderline Personality DisorderNCT00202215
Chrysalis Day Program Body Mass Index Study
A study testing Chrysalis Day Program in people with Borderline Personality Disorder and Eating Disorders, run by Queen's University at 1 site in Canada.
Trial summary
This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI) Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Borderline Personality Disorder, Eating Disorders
- What is being tested?
- Chrysalis Day Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2001to Jun 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clients of the Chrysalis Program
Who cannot join
- clients of the Chrysalis Program who do not consent to the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Providence Care Centre Mental Health Services
Kingston, Ontario, K7L 4X3
About this study
Official title: A Study on the Effects of a Personality Disorder Day Hospital Program on Clients Body Mass Index
This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)
Read the detailed description
As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients.
At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician.
When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values.
The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .
- Conditions
- Borderline Personality Disorder, Eating Disorders
- Being tested
- Chrysalis Day Program
- Keywords
- Day hospital treatment
- Medical subject headings
- Borderline Personality Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chrysalis Day ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index at time of enrolling in programme and at leaving
Measured: at entry and upon leaving the program
Secondary outcomes (2)
patient demographics relationship to outcome
Measured: upon entry and exit from the program
programme changes and relation to outcome
Measured: from start to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2001
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Stephen H McNevin, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202215
- Sponsor's protocol ID
- PDS002
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 16 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of a Personality Disorder Day Hospital Program on Clients Body Mass Index
- ClinicalTrials.gov ID
- NCT00202215
- Acronym / sponsor ID
- PDS002
- Conditions
- Borderline Personality Disorder, Eating Disorders
- Keywords
- Day hospital treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Sep 2005 (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.
This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)
Detailed description
As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients.
At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician.
When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values.
The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clients of the Chrysalis Program
Key exclusion criteria (1 listed)
- clients of the Chrysalis Program who do not consent to the study
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 |
|---|---|---|
| Chrysalis Day Program | Behavioural | – |
Primary outcome
Body Mass Index at time of enrolling in programme and at leaving
Time frame: at entry and upon leaving the program
2 secondary outcomes
patient demographics relationship to outcome
Time frame: upon entry and exit from the program
programme changes and relation to outcome
Time frame: from start to the end of the study
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 16 Oct 2007.
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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.
Stephen H McNevin, MD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chrysalis Day Program in people with Borderline Personality Disorder and Eating Disorders, run by Queen's University at 1 site in Canada.
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 1 inclusion and 1 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 16 Oct 2007. 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 Canada. 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.
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?
Body Mass Index at time of enrolling in programme and at leaving (time frame: at entry and upon leaving the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2007.