Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder

Borderline Personality Disorder Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00269139
• Other study ID #: 719371
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 21, 2005
• Last updated: February 17, 2006

Study information

• Verified date: December 2005
• Source: Laddis, Andreas, M.D.
• Contact: Andreas Laddis, MD
• Phone: 508-320-7895
• Email: andreas.laddis[@]dmh.state.ma.us
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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:

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual

• In behavioral crisis

Exclusion Criteria:

• Brain damage

• Currently intoxicated with alcohol or drugs or in withdrawal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders
• Post-Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Crisis resolution

Locations

Country	Name	City	State
United States	Cape Cod and Islands Community Mental Health Center	Pocasset	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Laddis, Andreas, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Psychiatric Rating Scale (BPRS) scores
Primary	Scores on Client Observation and Client Interview, tools designed for this study
Secondary	Patient interview and ratings for the value of the clinicians' interventions
Secondary	Staff interview and ratings for their own interventions