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

NCT03880071 | Withdrawn

• 1 other identifier: RECHMPL18_0044
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female; Borderline Personality Disorder

Keywords

Psychiatry; Suicidal Behavior; Borderline Personality Disorder; Prevention; Dialectic Behavioral Therapy; Acceptance Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up

  Evaluation and comparison of suicide attempts number before and after therapy between DBT and DBT+ACT groups with the Columbia-Suicide severity rating scale : indication of the number of proven suicide attempts and score from 0 to 5 depending on the severity of the suicide attempt

  At 1 year after the intervention

Secondary Outcomes (88)

• Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)

  At one week after the intervention

• Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)

  At 6 months after the intervention

• Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)

  At 12 months after the intervention

• Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)

  At one week after the intervention

• Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)

  At 6 months after the intervention

Study Arms (2)

DBT + ACT group

EXPERIMENTAL

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

Behavioral: DBT+ACT

DBT group

OTHER

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

Behavioral: DBT

Interventions

DBT+ACT 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 + ACT group

DBT 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)

DBT group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier: collaborator

Study Sites (1)

CHU Montpellier

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: November 30, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 9, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

FR (1)