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

Sponsor
Shalvata Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02397187
Collaborator
(none)
20
Enrollment
2
Arms
12
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: LOOP
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Mar 1, 2016

Arms and Interventions

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 Names:
  • 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 Names:
  • ST-CBT / Narrative

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Questionnaires [up to 28 days]

      Questionnaires filled upon being enrolled and at the end of the intervention

    2. Readmission rates [3 months]

      Readmission rates in the post-intervention period (3 months).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shalvata Mental Health Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shalvata Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT02397187
    Other Study ID Numbers:
    • 0003-15-SHA
    First Posted:
    Mar 24, 2015
    Last Update Posted:
    Mar 24, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Personality Disorders

    Study Results

    No Results Posted as of Mar 24, 2015