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临床试验/NCT03880071
NCT03880071撤回不适用

Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder

University Hospital, Montpellier1 个研究点 分布在 1 个国家开始时间: 2019年11月30日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years（Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

DBT + ACT group

Experimental
  • The experimental group (DBT+ ACT) led in Montpellier during 6 months.

干预措施: DBT+ACT (Behavioral)

DBT group

Other

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

干预措施: DBT (Behavioral)

结局指标

主要结局

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

时间窗: At 1 year after the intervention

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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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