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

Personality Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02397187
• Other study ID #: 0003-15-SHA
• Status: Not yet recruiting
• Phase: N/A
• First received: March 5, 2015
• Last updated: March 23, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaires	Questionnaires filled upon being enrolled and at the end of the intervention	up to 28 days	No
Primary	Readmission rates	Readmission rates in the post-intervention period (3 months).	3 months	No