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Trial record 12 of 607 for:    Personality Disorders

Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients (LOOP-PersDis)

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ClinicalTrials.gov Identifier: NCT02397187
Recruitment Status : Unknown
Verified March 2015 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:
The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients

Condition or disease Intervention/treatment Phase
Personality Disorders Behavioral: LOOP Not Applicable

Detailed Description:

The current study attempts to design a short-term intervention aimed at stabilizing decompensate personality disorder patients in hospitalization. The study is structured as a pilot study, thus will enroll 20 patients only. Patients, upon being hospitalized and after signing the consent to participate in the study, will be randomized to two groups: The first will be treated by the novel, LOOP, concept` the other will be TAU, as routinely done with PersDis patients in the investigators facility. The outcome parameters will be changes in series of questionnaires filled upon being enrolled and at the end of the intervention. Another outcome parameter will be readmission rates in the post-intervention period (3 months).

The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where the investigators experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Assessment of the Efficacy of a Structured, Dimension-based, STI (Short Term Intervention) in De-compensated Personality-disorder, Hospitalized, Patients
Study Start Date : March 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LOOP intervention

Patients enrolled in this arm will be treated by the LOOP interventional technique.

The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where our experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.

Behavioral: LOOP
The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where our experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.
Other Name: ST-CBT / Narrative

Active Comparator: TAU
Patients enrolled in this arm will be TAU, which is based upon short-term supportive PT.
Behavioral: LOOP
The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where our experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.
Other Name: ST-CBT / Narrative




Primary Outcome Measures :
  1. Questionnaires [ Time Frame: up to 28 days ]
    Questionnaires filled upon being enrolled and at the end of the intervention

  2. Readmission rates [ Time Frame: 3 months ]
    Readmission rates in the post-intervention period (3 months).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cluster 2 diagnosis
  • No suicide attemts 1 month prior to admission
  • Regularly treated
  • An active support system
  • No urgent need for Rx changes

Exclusion Criteria:

  • Drug abuse
  • An active Axis 1 diagnosis that requires change in Rx
  • Unable to read/write fluently

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Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT02397187     History of Changes
Other Study ID Numbers: 0003-15-SHA
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Disease
Personality Disorders
Pathologic Processes
Mental Disorders