DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder

NCT ID: NCT03880071

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-03-09

Brief Summary

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According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

Borderline personality disorder (BPD) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

BPD is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a BPD.

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a BPD are highly sensitive to it. Unfortunately, patient care for this disorder is limited. Pharmacological strategies didn't show any efficacy and psychotherapies, although proven effective, are difficult to set up.

As BPD is strongly related to suicidal attempts it appears to be a good model to study suicidal behavior. Thus, this study could improve knowledge in this field.

Suicidal behavior in patients receiving the standard therapy (dialectic behavioural therapy: DBT) will be compared to patients receiving dialectical behavior therapy and acceptance commitment therapy (ACT).

Clinical data reflecting how the participant is feeling will be collected as well.

Detailed Description

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An emotional dysregulation has been linked to suicidal behavior in patients with BPD.

Up to this date, no program had combined dialectical behavior therapy with acceptance commitment therapy.

DBT aims to teach skills in four different fields : mindfulness, emotional regulation, distress tolerance and interpersonal efficiency.

ACT helps to develop metacognitive skills and to identify what makes sense in one's life.

Because 75% of BPD patients are women, the study will only focus on them.

Patients will be evaluated during 4 visits :

* Inclusion : 1 or 2 weeks before the first session of therapy. During this visit patients will undergo a clinical exam and will complete questionnaires.
* First follow-up visit : 6 months after the first session (for the experimental group) or 12 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, therapy satisfaction and cost- effectiveness ratio will be evaluated
* Second follow-up visit : 12 months after the first sessions (for the experimental group) or 18 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, and cost- effectiveness ratio will be evaluated
* Third follow-up visit : 18 months after the first session (for the experimental group) or 24 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, and cost- effectiveness ratio will be evaluated The hypothesis is that DBT+ ACT allows reducing suicidal recidivism, reducing economical cost linked to BPD and improving quality of life and functioning among patients.

Conditions

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Female Borderline Personality Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DBT + ACT group

\- The experimental group (DBT+ ACT) led in Montpellier during 6 months.

Group Type EXPERIMENTAL

DBT+ACT

Intervention Type BEHAVIORAL

\- The experimental group (DBT+ ACT) will have: 25 therapy group sessions (1 sessions of 2 hours once a week) 25 individual interview sessions (1 sessions of 1 hour once a week) will receive 25 group sessions and 25 individual ones during 6 months.

DBT group

The control group (DBT) led in Geneva during 12 months.

Group Type OTHER

DBT

Intervention Type BEHAVIORAL

The control group (DBT) will have:

50 therapy group sessions (1 session of 2h30 once a week) 50 individual interview sessions (1 sessions of 1 hour once a week)

Interventions

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DBT+ACT

\- The experimental group (DBT+ ACT) will have: 25 therapy group sessions (1 sessions of 2 hours once a week) 25 individual interview sessions (1 sessions of 1 hour once a week) will receive 25 group sessions and 25 individual ones during 6 months.

Intervention Type BEHAVIORAL

DBT

The control group (DBT) will have:

50 therapy group sessions (1 session of 2h30 once a week) 50 individual interview sessions (1 sessions of 1 hour once a week)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Being a woman
* Between 18 and 50 years old
* Clinical diagnosis of BPD using the Structured Clinical Interview for DSM-IV-TR ( Diagnostic and Statistical Manual of mental disorders) Axis II Personality Disorders)
* Having signed the informed consent
* Able to realize all the visits and therapy sessions
* Able to speak, read and understand French

Exclusion Criteria

* Life time diagnosis of schizophrenia
* Life time diagnosis of intellectual disability
* Not able to read and write
* Refusal of participation
* Subject protected by law (guardianship)
* Deprived of liberty Subject (by judicial or administrative decision)
* Not belonging to social safety system
* Exclusion period in relation to another protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Montpellier

Montpellier, Hérault, France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0044

Identifier Type: -

Identifier Source: org_study_id

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