FemaleDIABOLONCT03880071
DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder
A study testing DBT+ACT and DBT in people with Female and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Female, Borderline Personality Disorder
- What is being tested?
- DBT+ACT and DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2019to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Female, Borderline Personality Disorder
- Being tested
- DBT+ACT, DBT
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Prevention, Dialectic Behavioral Therapy, Acceptance Commitment Therapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT+ACTBehavioural
- 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.
DBTBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| DBT + ACT group | Experimental | - The experimental group (DBT+ ACT) led in Montpellier during 6 months. Receives: Behavioral: DBT+ACT |
| DBT group | Other | The control group (DBT) led in Geneva during 12 months. Receives: Behavioral: DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 year after the intervention
Secondary outcomes (88)
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At one week after the intervention
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At 6 months after the intervention
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: At 12 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: At 12 months after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At one week after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At 6 months after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
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
Measured: At 12 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
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
Measured: At 12 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: At 12 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
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)
Measured: At 12 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: At 6 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)
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)
Measured: At 12 months after the intervention
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
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)
Measured: At one week after the intervention
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
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)
Measured: At 6 months after the intervention
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
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)
Measured: At 12 months after the intervention
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
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)
Measured: At one week after the intervention
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
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)
Measured: At 6 months after the intervention
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
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)
Measured: At 12 months after the intervention
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
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%.
Measured: At one week after the intervention
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
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%.
Measured: At 6 months after the intervention
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
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%.
Measured: At 12 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
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)
Measured: At one week after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
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)
Measured: At 6 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
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)
Measured: At 12 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
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)
Measured: At one week after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
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)
Measured: At 6 months after the intervention
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
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)
Measured: At 12 months after the intervention
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
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)
Measured: At 6 months after the intervention
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
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)
Measured: At 12 months after the intervention
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
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)
Measured: At one week after the intervention
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
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)
Measured: At 6 months after the intervention
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
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)
Measured: At 12 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
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
Measured: At one week after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
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
Measured: At 6 months after the intervention
Hopelessness using the Beck Hopelessness Scale (BHS)
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.
Measured: At 12 months after the intervention
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
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.
Measured: At one week after the intervention
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
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.
Measured: At 6 months after the intervention
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
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.
Measured: At 12 months after the intervention
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
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).
Measured: At one week after the intervention
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
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).
Measured: At 6 months after the intervention
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
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).
Measured: At 12 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
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).
Measured: At one week after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
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).
Measured: At 6 months after the intervention
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
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).
Measured: At 12 months after the intervention
Meaning in life assessment using Life Regard Index (LRI)
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
Measured: At one week after the intervention
Meaning in life assessment using Life Regard Index (LRI)
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
Measured: At 6 months after the intervention
Meaning in life assessment using Life Regard Index (LRI)
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
Measured: At 12 months after the intervention
Satisfaction of the intervention using the Likert scales rating from 0 (not at all satisfied) to 10 (extremely satisfied)
Evaluation of the satisfaction about the intervention within the two groups (DBT versus DBT+ACT)
Measured: At one week after the intervention
Quality of life related to health using the EQ5D-3L questionnaire
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.
Measured: At 6 months after the intervention
Quality of life related to health using the EQ5D-3L questionnaire
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.
Measured: At 12 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
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.
Measured: At one week after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
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.
Measured: At 6 months after the intervention
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
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.
Measured: At 12 months after the intervention
Global functioning using the Global Assessment of Functioning Scale (GAF)
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
Measured: At one week after the intervention
Global functioning using the Global Assessment of Functioning Scale (GAF)
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
Measured: At 6 months after the intervention
Global functioning using the Global Assessment of Functioning Scale (GAF)
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
Measured: At 12 months after the intervention
Incremental cost-effectiveness ratio (ICER)
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)
Measured: At 1 year follow-up
Incremental cost-utility ratio (ICUR)
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)
Measured: At 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start30 Nov 2019
- Primary completion1 Mar 2020
- Study completion9 Mar 2020
Why it stopped: Abandoned study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880071
- Sponsor's protocol ID
- RECHMPL18_0044
- Acronym
- DIABOLO
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03880071
- Acronym / sponsor ID
- DIABOLO / RECHMPL18_0044
- Conditions
- Female, Borderline Personality Disorder
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Prevention, Dialectic Behavioral Therapy, Acceptance Commitment Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Abandoned study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT + ACT group | Experimental | Behavioral: DBT+ACT- The experimental group (DBT+ ACT) led in Montpellier during 6 months. |
| DBT group | Other | Behavioral: DBTThe control group (DBT) led in Geneva during 12 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | DBT + ACT group |
| DBTThe 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) | Behavioural | DBT group |
Primary outcome
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
88 secondary outcomes
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At one week after the intervention
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At 6 months after the intervention
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 12 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Time frame: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Time frame: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At 12 months after the intervention
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
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
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
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: At one week after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: At 6 months after the intervention
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: At 12 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)
Time frame: 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)
Time frame: 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)
Time frame: At 12 months after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At one week after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At 6 months after the intervention
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: At 12 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Time frame: At 12 months after the intervention
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
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
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
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
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
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
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
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
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
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: At one week after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: At 6 months after the intervention
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Time frame: 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)
Time frame: At one week after the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT+ACT and DBT in people with Female and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.