Personality DisordersLOOP-PersDisNCT02397187
Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients
A study testing LOOP in people with Personality Disorders, run by Shalvata Mental Health Center.
Trial summary
The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Personality Disorders
- What is being tested?
- LOOP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cluster 2 diagnosis
- No suicide attemts 1 month prior to admission
- Regularly treated
- An active support system
- No urgent need for Rx changes
Who cannot join
- Drug abuse
- An active Axis 1 diagnosis that requires change in Rx
- Unable to read/write fluently
About this study
Official title: The Assessment of the Efficacy of a Structured, Dimension-based, STI (Short Term Intervention) in De-compensated Personality-disorder, Hospitalized, Patients
The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients
Read the 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.
- Conditions
- Personality Disorders
- Being tested
- LOOP
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOOPBehavioural
Also called ST-CBT / Narrative
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: LOOP |
| TAU | Active comparator | Patients enrolled in this arm will be TAU, which is based upon short-term supportive PT. Receives: Behavioral: LOOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires
Questionnaires filled upon being enrolled and at the end of the intervention
Measured: up to 28 days
Readmission rates
Readmission rates in the post-intervention period (3 months).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397187
- Sponsor's protocol ID
- 0003-15-SHA
- Acronym
- LOOP-PersDis
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Efficacy of a Structured, Dimension-based, STI (Short Term Intervention) in De-compensated Personality-disorder, Hospitalized, Patients
- ClinicalTrials.gov ID
- NCT02397187
- Acronym / sponsor ID
- LOOP-PersDis / 0003-15-SHA
- Conditions
- Personality Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOOP intervention | Experimental | Behavioral: LOOPPatients 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. |
| TAU | Active comparator | Behavioral: LOOPPatients enrolled in this arm will be TAU, which is based upon short-term supportive PT. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cluster 2 diagnosis
- No suicide attemts 1 month prior to admission
- Regularly treated
- An active support system
- No urgent need for Rx changes
Key exclusion criteria (3 listed)
- Drug abuse
- An active Axis 1 diagnosis that requires change in Rx
- Unable to read/write fluently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOOPAlso: ST-CBT / NarrativeThe 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. | Behavioural | LOOP intervention, TAU |
Primary outcome
Questionnaires
Time frame: up to 28 days
Questionnaires filled upon being enrolled and at the end of the intervention
Readmission rates
Time frame: 3 months
Readmission rates in the post-intervention period (3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LOOP in people with Personality Disorders, run by Shalvata Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaires (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.