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Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial

Primary Purpose

Treatment 1:Dialectical Behavior Therapy (DBT), Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), Placebo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DBT
DDP
control group
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment 1:Dialectical Behavior Therapy (DBT)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between 18 and 45 years old
  • diagnosis of BPD,
  • history of a suicide attempt within the prior year with presence of current suicidal ideation,
  • agrees to participate in psychotherapy
  • signed informed consent,

Exclusion Criteria:

  • meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    DBT

    DDP

    control group

    Arm Description

    Standard DBT treatment

    dynamic deconstructive psychotherapy (DDP) treatment, is part of a trend of dynamic therapies to treat borderline personality disorder. DDP is a treatment specifically developed for a population with more severe symptoms those dealing with borderline personality disorder.

    patients on the waiting list for treatment, or patients in the hospital under routine care. Which will form the control group.

    Outcomes

    Primary Outcome Measures

    Incremental cost-effectiveness ratio (ICER)
    The measure will be assessed by comparing health care use costs in ratio to improvement on the Columbia hardware rating scale.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2020
    Last Updated
    March 12, 2020
    Sponsor
    Shalvata Mental Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04309045
    Brief Title
    Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
    Official Title
    Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    October 22, 2024 (Anticipated)
    Study Completion Date
    October 22, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. These findings highlight the importance of effective outpatient treatments for BPD patients in public psychiatric hospital settings. In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP).
    Detailed Description
    In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP). Sixty-eight participants with BPD will be randomized to each of two treatment groups. Participants and therapists will be recruited from the Shalvata MHC, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in Israel. A blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with DDP or DBT. Therapist adherence will be systematically assessed in both treatments for 10% of sessions. Primary outcome measure will be comprised of the Incremental cost-effectiveness ratio (ICER), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. Secondary outcome measures will include BPD and depression symptom severity and quality of life. This study was submitted to the institutional review board of the Shalvata MHC in November 2019, and is expected to be approved by late Janury 2020.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment 1:Dialectical Behavior Therapy (DBT), Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), Placebo

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DBT
    Arm Type
    Experimental
    Arm Description
    Standard DBT treatment
    Arm Title
    DDP
    Arm Type
    Active Comparator
    Arm Description
    dynamic deconstructive psychotherapy (DDP) treatment, is part of a trend of dynamic therapies to treat borderline personality disorder. DDP is a treatment specifically developed for a population with more severe symptoms those dealing with borderline personality disorder.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    patients on the waiting list for treatment, or patients in the hospital under routine care. Which will form the control group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    DBT
    Intervention Description
    Today, the most well-known and established treatment for borderline personality disorder is Dialectical Behavior Therapy (DBT) that developed by Marsha Linhan in the 1990s. DBT is currently used in other disorders such as: eating disorders, addictions, impulse control problems and bipolar disorder. Various studies have found a beneficial effect for this treatment in various areas: decreased suicidal thoughts and attempts and self-harm behaviors, improvements in suicide attempts, anger levels, impulsive behaviors, depressive symptoms, The use of drugs, the percentage of dropouts from treatment, number Hospitalization and general function.
    Intervention Type
    Behavioral
    Intervention Name(s)
    DDP
    Intervention Description
    DDP treatment is part of a trend of dynamic therapies to treat borderline personality disorder. The DDP focuses on deficiencies in the emotional experience processing and is performed in the form of weekly, individual sessions with a trained therapist over a 12-18 month period. Treatment is based on the need to correct three neurocognitive functions responsible for adaptive processing of emotional experiences: association (the ability to recognize, understand their existence, and experience a sequence of emotional experiences), attribution (the ability to make complex attributions about the self and others), and the ability to make realistic attribution, about the self and the other. Interventions that activate these three functions are the basis for DDP treatment.
    Intervention Type
    Other
    Intervention Name(s)
    control group
    Intervention Description
    Patients on the waiting list for treatment, or patients in the hospital under routine care.
    Primary Outcome Measure Information:
    Title
    Incremental cost-effectiveness ratio (ICER)
    Description
    The measure will be assessed by comparing health care use costs in ratio to improvement on the Columbia hardware rating scale.
    Time Frame
    The expected duration of treatment is about one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: between 18 and 45 years old diagnosis of BPD, history of a suicide attempt within the prior year with presence of current suicidal ideation, agrees to participate in psychotherapy signed informed consent, Exclusion Criteria: meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial

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