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

Primary Purpose

Personality Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LOOP
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Personality Disorders

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LOOP intervention

    TAU

    Arm Description

    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.

    Patients enrolled in this arm will be TAU, which is based upon short-term supportive PT.

    Outcomes

    Primary Outcome Measures

    Questionnaires
    Questionnaires filled upon being enrolled and at the end of the intervention
    Readmission rates
    Readmission rates in the post-intervention period (3 months).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2015
    Last Updated
    March 23, 2015
    Sponsor
    Shalvata Mental Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02397187
    Brief Title
    Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients
    Acronym
    LOOP-PersDis
    Official Title
    The Assessment of the Efficacy of a Structured, Dimension-based, STI (Short Term Intervention) in De-compensated Personality-disorder, Hospitalized, Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    March 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shalvata Mental Health Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Personality Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LOOP intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    TAU
    Arm Type
    Active Comparator
    Arm Description
    Patients enrolled in this arm will be TAU, which is based upon short-term supportive PT.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LOOP
    Other Intervention Name(s)
    ST-CBT / Narrative
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Questionnaires
    Description
    Questionnaires filled upon being enrolled and at the end of the intervention
    Time Frame
    up to 28 days
    Title
    Readmission rates
    Description
    Readmission rates in the post-intervention period (3 months).
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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