Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269139
Status:
UNKNOWN
Last Update Posted:
2006-02-20
First Post:
2005-12-21
Brief Title:
Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder
Sponsor:
Laddis Andreas MD
Organization:
Laddis Andreas MD
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The term behavioral crisis is used strictly for periods of uncontrollable urges to repeat mental or outward activity eg flashbacks cutting binging on food drugs or sex with no intervals to rethink ones priorities or to consider others direction
The clinical hypothesis states in two steps that
1 the perception of a life crisis precedes and then underlies every behavioral crisis
2 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
The clinical hypothesis states in two steps that
1 the perception of a life crisis precedes and then underlies every behavioral crisis
2 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None