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Trial record 5 of 269 for:    personality AND therapy | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03880071
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Female Borderline Personality Disorder Behavioral: DBT+ACT Behavioral: DBT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DBT + ACT group
- The experimental group (DBT+ ACT) led in Montpellier during 6 months.
Behavioral: 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.

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





Primary Outcome Measures :
  1. Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up [ Time Frame: 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


Secondary Outcome Measures :
  1. Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  2. Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  3. Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  4. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  5. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  6. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  7. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  8. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  9. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  10. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  11. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  12. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  13. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  14. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  15. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  16. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  17. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  18. Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  19. 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) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  20. 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) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  21. 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) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  22. Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  23. Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  24. Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale

  25. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  26. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  27. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT

  28. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  29. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  30. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  31. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  32. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  33. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  34. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  35. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  36. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)

  37. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  38. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  39. Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  40. 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) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  41. 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) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  42. 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) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)

  43. Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)

  44. Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the has to choose a score from 0 to 4 (from not at all to very strongly)

  45. Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)

  46. Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)

  47. Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)

  48. Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)

  49. Evolution of propensity to dissociation using the Dissociative Experience Scale (DES) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.

  50. Evolution of propensity to dissociation using the Dissociative Experience Scale (DES) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.

  51. Evolution of propensity to dissociation using the Dissociative Experience Scale (DES) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.

  52. Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)

  53. Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of has to choose a score from 0 to 3 (from almost never to almost always)

  54. Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)

  55. Anxiety state using the State-Trait Anxiety Inventory (STAI-State) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)

  56. Anxiety state using the State-Trait Anxiety Inventory (STAI-State) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)

  57. Anxiety state using the State-Trait Anxiety Inventory (STAI-State) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)

  58. Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)

  59. Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)

  60. Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)

  61. Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)

  62. Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)

  63. Hopelessness using the Beck Hopelessness Scale (BHS) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false

  64. Hopelessness using the Beck Hopelessness Scale (BHS) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false

  65. Hopelessness using the Beck Hopelessness Scale (BHS) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false.

  66. Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.

  67. Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.

  68. Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.

  69. Acceptance assessment using the Acceptance and Action Questionnaire (AAQII) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).

  70. Acceptance assessment using the Acceptance and Action Questionnaire (AAQII) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).

  71. Acceptance assessment using the Acceptance and Action Questionnaire (AAQII) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).

  72. Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).

  73. Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).

  74. Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).

  75. Meaning in life assessment using Life Regard Index (LRI) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree

  76. Meaning in life assessment using Life Regard Index (LRI) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree

  77. Meaning in life assessment using Life Regard Index (LRI) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree

  78. Satisfaction of the intervention using the Likert scales rating from 0 (not at all satisfied) to 10 (extremely satisfied) [ Time Frame: At one week after the intervention ]
    Evaluation of the satisfaction about the intervention within the two groups (DBT versus DBT+ACT)

  79. Quality of life related to health using the EQ5D-3L questionnaire [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.

  80. Quality of life related to health using the EQ5D-3L questionnaire [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.

  81. Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.

  82. Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.

  83. Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.

  84. Global functioning using the Global Assessment of Functioning Scale (GAF) [ Time Frame: At one week after the intervention ]
    Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient

  85. Global functioning using the Global Assessment of Functioning Scale (GAF) [ Time Frame: At 6 months after the intervention ]
    Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient

  86. Global functioning using the Global Assessment of Functioning Scale (GAF) [ Time Frame: At 12 months after the intervention ]
    Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient

  87. Incremental cost-effectiveness ratio (ICER) [ Time Frame: At 1 year follow-up ]
    Evaluation and comparison of the incremental cost-effectiveness ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)

  88. Incremental cost-utility ratio (ICUR) [ Time Frame: At 1 year follow-up ]
    Evaluation and comparison of the incremental cost-utility ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880071


Contacts
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Contact: Déborah Ducasse, MD 04 67 33 85 81 d-ducasse@chu-montpellier.fr

Locations
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France
CHU Montpellier Not yet recruiting
Montpellier, Hérault, France, 34295
Contact: Laetitia Lacourt    04 67 33 56 63    laetitialacourt37@gmail.com   
Contact: Catherine Genty    04 67 99 61 45    c-genty@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03880071     History of Changes
Other Study ID Numbers: RECHMPL18_0044
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Psychiatry
Suicidal Behavior
Borderline Personality Disorder
Prevention
Dialectic Behavioral Therapy
Acceptance Commitment Therapy

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders