NCT02397187

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

March 5, 2015

Last Update Submit

March 23, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Questionnaires

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

    up to 28 days

  • Readmission rates

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

    3 months

Study Arms (2)

LOOP intervention

EXPERIMENTAL

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

TAU

ACTIVE COMPARATOR

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

Behavioral: LOOP

Interventions

LOOPBEHAVIORAL

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.

Also known as: ST-CBT / Narrative
LOOP interventionTAU

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 24, 2015

Record last verified: 2015-03