Clinical trial NCT03880071: DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder
Official title: Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Female
Borderline Personality Disorder
Keywords: Psychiatry
Suicidal Behavior
Borderline Personality Disorder
Prevention
Dialectic Behavioral Therapy
Acceptance Commitment Therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
First posted: 2019-03-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up
timeFrame: At 1 year after the intervention
Secondary outcomes:
measure: Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At 12 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At one week after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At 6 months after the intervention
measure: Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At 12 months after the intervention
measure: Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At one week after the intervention
measure: Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 6 months after the intervention
measure: Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
timeFrame: At 12 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At one week after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At 6 months after the intervention
measure: Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
timeFrame: At 12 months after the intervention
measure: Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
timeFrame: At one week after the intervention
measure: Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
timeFrame: At 6 months after the intervention
measure: Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
timeFrame: At 12 months after the intervention
measure: Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: At one week after the intervention
measure: Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: At 6 months after the intervention
measure: Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: At 12 months after the intervention
measure: Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
timeFrame: At one week after the intervention
measure: Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
timeFrame: At 6 months after the intervention
measure: Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
timeFrame: At 12 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
timeFrame: At one week after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
timeFrame: At 6 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
timeFrame: At 12 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At one week after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 6 months after the intervention
measure: Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
timeFrame: At 12 months after the intervention
measure: Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
timeFrame: At 6 months after the intervention
measure: Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
timeFrame: At 12 months after the intervention
measure: Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
timeFrame: At one week after the intervention
measure: Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
timeFrame: At 6 months after the intervention
measure: Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
timeFrame: At 12 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At one week after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 6 months after the intervention
measure: Hopelessness using the Beck Hopelessness Scale (BHS)
timeFrame: At 12 months after the intervention
measure: Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
timeFrame: At one week after the intervention
measure: Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
timeFrame: At 6 months after the intervention
measure: Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
timeFrame: At 12 months after the intervention
measure: Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
timeFrame: At one week after the intervention
measure: Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
timeFrame: At 6 months after the intervention
measure: Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
timeFrame: At 12 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At one week after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 6 months after the intervention
measure: Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
timeFrame: At 12 months after the intervention
measure: Meaning in life assessment using Life Regard Index (LRI)
timeFrame: At one week after the intervention
measure: Meaning in life assessment using Life Regard Index (LRI)
timeFrame: At 6 months after the intervention
measure: Meaning in life assessment using Life Regard Index (LRI)
timeFrame: At 12 months after the intervention
measure: Satisfaction of the intervention using the Likert scales rating from 0 (not at all satisfied) to 10 (extremely satisfied)
timeFrame: At one week after the intervention
measure: Quality of life related to health using the EQ5D-3L questionnaire
timeFrame: At 6 months after the intervention
measure: Quality of life related to health using the EQ5D-3L questionnaire
timeFrame: At 12 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At one week after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 6 months after the intervention
measure: Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
timeFrame: At 12 months after the intervention
measure: Global functioning using the Global Assessment of Functioning Scale (GAF)
timeFrame: At one week after the intervention
measure: Global functioning using the Global Assessment of Functioning Scale (GAF)
timeFrame: At 6 months after the intervention
measure: Global functioning using the Global Assessment of Functioning Scale (GAF)
timeFrame: At 12 months after the intervention
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: At 1 year follow-up
measure: Incremental cost-utility ratio (ICUR)
timeFrame: At 1 year follow-up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
state: Hérault
Study officials:
References: