Borderline Personality DisorderPhase 1NCT00269139
Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder
A Phase 1 study testing Crisis resolution in people with Borderline Personality Disorder and Post-Traumatic Stress Disorders, run by Laddis, Andreas, M.D. at 1 site in United States.
Trial summary
Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Post-Traumatic Stress Disorders
- What is being tested?
- Crisis resolution
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual
- In behavioral crisis
Who cannot join
- Brain damage
- Currently intoxicated with alcohol or drugs or in withdrawal
Trial locations and contacts
1 site in 1 country.
United States1 site
Cape Cod and Islands Community Mental Health Center
Pocasset, Massachusetts, 02559
Andreas Laddis, MD
About this study
Official title: Study of Outcome With an Intervention From the Cape Cod Model of Psychotherapy for Subjects in a Behavioral Crisis and With the Diagnosis of Borderline Personality Disorder (BPD) or Post-Traumatic Stress Disorder (PTSD)
Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction.
The clinical hypothesis states, in two steps, that:
- the perception of a life crisis precedes and then underlies every behavioral crisis;
- the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.
Read the detailed description
Subjects in the experimental group will be treated by Dr. Laddis after their admission to a crisis stabilization unit (CSU) or to an inpatient unit (IPU) for a behavioral crisis. Subjects will be included at random, as assigned to Dr. Laddis according to his routine duties at those units.
Subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. That treatment will constitute "treatment as usual". Clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes.
The subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. The testing will be done with the Brief Psychiatric Rating Scale (BPRS), as well as with a set of criteria devised by Dr. Laddis to measure the outward behavior and the mental events during behavioral crisis. The patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. The raters will be trained for interrater reliability and they will not be informed about the hypothesis.
- Being tested
- Crisis resolution
- Keywords
- Behavioral crisis, Perception of social crisis, Repetition compulsion, Intrusive mental events, Uncontrollable urges
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis resolutionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS) scores
Scores on Client Observation and Client Interview, tools designed for this study
Secondary outcomes (2)
Patient interview and ratings for the value of the clinicians' interventions
Staff interview and ratings for their own interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Laddis, Andreas, M.D.
- Investigators
- Andreas Laddis, MD, Principal investigator, Cape Cod and Islands Community Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269139
- Sponsor's protocol ID
- 719371
- Status last verified
- Dec 2005
- First submitted
- 21 Dec 2005
- Last updated
- 20 Feb 2006
- Results posted
- No
Publications
Laddis A. Outcome of crisis intervention for borderline personality disorder and post traumatic stress disorder: a model for modification of the mechanism of disorder in complex post traumatic syndromes. Ann Gen Psychiatry. 2010 Apr 27;9:19. doi: 10.1186/1744-859X-9-19.
PubMed 20420716
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Outcome With an Intervention From the Cape Cod Model of Psychotherapy for Subjects in a Behavioral Crisis and With the Diagnosis of Borderline Personality Disorder (BPD) or Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00269139
- Acronym / sponsor ID
- 719371
- Keywords
- Behavioral crisis, Perception of social crisis, Repetition compulsion, Intrusive mental events, Uncontrollable urges
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Laddis, Andreas, M.D.
- First posted
- 23 Dec 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.
Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction.
The clinical hypothesis states, in two steps, that:
- the perception of a life crisis precedes and then underlies every behavioral crisis;
- the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.
Detailed description
Subjects in the experimental group will be treated by Dr. Laddis after their admission to a crisis stabilization unit (CSU) or to an inpatient unit (IPU) for a behavioral crisis. Subjects will be included at random, as assigned to Dr. Laddis according to his routine duties at those units.
Subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. That treatment will constitute "treatment as usual". Clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes.
The subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. The testing will be done with the Brief Psychiatric Rating Scale (BPRS), as well as with a set of criteria devised by Dr. Laddis to measure the outward behavior and the mental events during behavioral crisis. The patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. The raters will be trained for interrater reliability and they will not be informed about the hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual
- In behavioral crisis
Key exclusion criteria (2 listed)
- Brain damage
- Currently intoxicated with alcohol or drugs or in withdrawal
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 |
|---|---|---|
| Crisis resolution | Behavioural | – |
Primary outcome
Brief Psychiatric Rating Scale (BPRS) scores
Scores on Client Observation and Client Interview, tools designed for this study
2 secondary outcomes
Patient interview and ratings for the value of the clinicians' interventions
Staff interview and ratings for their own interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2006.
- Derived from this study: PubMed 20420716Laddis A. Outcome of crisis intervention for borderline personality disorder and post traumatic stress disorder: a model for modification of the mechanism of disorder in complex post traumatic syndromes. Ann Gen Psychiatry. 2010 Apr 27;9:19. doi: 10.1186/1744-859X-9-19.
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
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.
Andreas Laddis, MD principal investigator
Cape Cod and Islands Community Mental Health Center
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 Crisis resolution in people with Borderline Personality Disorder and Post-Traumatic Stress Disorders, run by Laddis, Andreas, M.D. 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Laddis, MD (508-320-7895, andreas.laddis@dmh.state.ma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) scores. The study lists 2 primary outcomes in all. 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 NCT00269139, 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 Feb 2006.