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
About this trial
This is an interventional treatment trial for Treatment 1:Dialectical Behavior Therapy (DBT)
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.
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
NCT ID
NCT04309045
First Posted
March 12, 2020
Last Updated
March 12, 2020
Sponsor
Shalvata Mental Health Center
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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