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Outcome of Crisis Intervention - Article


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Crisis




Clinical Trial: Outcome of Crisis Intervention

This study is not yet open for patient recruitment.
Verified by Laddis, Andreas, M.D. December 2005

Sponsored by: Laddis, Andreas, M.D.
Information provided by: Laddis, Andreas, M.D.
ClinicalTrials.gov Identifier: NCT00269139

Purpose

Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with BPD or 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 a) the perception of a life crisis precedes and then underlies every behavioral crisis; b) 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.

Condition Intervention Phase
Borderline Personality Disorder
Post-Traumatic Stress Disorder
 Behavior: Crisis resolution
Phase I

MedlinePlus related topics:  Personality Disorders;   Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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)

Further study details as provided by Laddis, Andreas, M.D.:
Primary Outcomes: BPRS scores; Scores with Client Observation and Client Interview, tools designed for this study
Secondary Outcomes: Patient interview and ratings for the value of the clinicians'''' interventions; Staff interview and ratings for their own interventions
Expected Total Enrollment:  40

Study start: December 2005

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 wil 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.

Eligibility

Ages Eligible for Study:  19 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00269139

Andreas Laddis, MD      508-320-7895    andreas.laddis@dmh.state.ma.us

Massachusetts
      Cape Cod and Islands Community Mental Health Center, Pocasset,  Massachusetts,  02559,  United States
Andreas Laddis, MD,  Principal Investigator

Study chairs or principal investigators

Andreas Laddis, MD,  Principal Investigator,  Cape Cod and Islands Community Mental Health Center   

More Information

Study ID Numbers:  719371
Last Updated:  December 22, 2005
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00269139
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10

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December 4, 2008



Page Updated: November 5, 2004
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