NCT04309045

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).

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

March 12, 2020

Last Update Submit

March 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    The expected duration of treatment is about one year

Study Arms (3)

DBT

EXPERIMENTAL

Standard DBT treatment

Behavioral: DBT

DDP

ACTIVE COMPARATOR

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.

Behavioral: DDP

control group

PLACEBO COMPARATOR

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

Other: control group

Interventions

DBTBEHAVIORAL

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.

DBT
DDPBEHAVIORAL

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.

DDP

Patients on the waiting list for treatment, or patients in the hospital under routine care.

control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

April 1, 2020

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

March 16, 2020

Record last verified: 2020-03