Borderline Personality Disorder (BPD)TRAULNCT07123974
Implementing a Therapy for Complex Trauma in French-Speaking Settings
A study testing Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) in people with Borderline Personality Disorder (BPD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Many individuals living with borderline personality disorder (BPD) have experienced childhood trauma, such as abuse or neglect. A significant number of them also meet the criteria for post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder (BPD), Complex Post-Traumatic Stress Disorder (CPTSD), Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2023to 1 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD according to the DSM caused by sexual or physical abuse up to the age of 18.
- Three or more criteria for borderline personality disorder (BPD) according to the SCID-II, including affective instability.
- Availability for one year of outpatient treatment (psychotherapy).
- Access to an email address usable for secure links to questionnaires.
- Fluent French-speaking.
Who cannot join
- Psychotic disorder, bipolar I disorder, intellectual disability, or severe psychopathology requiring immediate care as determined by the treating psychiatrist.
- Severe suicide attempt within two months prior to the inclusion visit.
- Medical condition preventing inclusion (e.g., pregnancy).
- Highly unstable living situation (e.g., homelessness).
- Current substance dependence.
- Having received specific treatment for PTSD or BPD within the year preceding the inclusion visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
About this study
Official title: Implementation Study of a Psychotherapy for Complex Trauma in a French-speaking Setting
Many individuals living with borderline personality disorder (BPD) have experienced childhood trauma, such as abuse or neglect. A significant number of them also meet the criteria for post-traumatic stress disorder (PTSD). However, standard psychotherapies often do not address both conditions at the same time, which can affect treatment outcomes.
A research team in Germany developed and validated a 45-week individual psychotherapy that has shown promising results for individuals coping with both BPD and PTSD. It has already been adapted and offered in English-speaking settings such as Toronto and Boston.
This study aims to adapt this therapy into French in Quebec. Over 24 months, we will conduct a mixed-methods observational study to evaluate changes in symptoms (BPD, PTSD, and other comorbidities) and in daily functioning.
- Conditions
- Borderline Personality Disorder (BPD), Complex Post-Traumatic Stress Disorder (CPTSD), Post-Traumatic Stress Disorder, PTSD
- Being tested
- Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD)
- Keywords
- Psychotherapy research, DBT-PTSD, Mixed-Methods study
- Medical subject headings
- Borderline Personality Disorder, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD)Behavioural
DBT-PTSD is 45-week individual psychotherapy (DBT-PTSD) designed to treat adults presenting with both borderline personality disorder (BPD) and complex post-traumatic stress disorder (C-PTSD). The intervention integrates dialectical behavior therapy (DBT) skills, trauma-focused exposure-based interventions, and strategies from compassion-focused therapy and acceptance and commitment therapy. All participants will receive the full sequence of the therapy in outpatient settings, following the structured treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) | Experimental | Participants receive the Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) psychotherapy over 45 weekly individual outpatient sessions. All participants followed the same treatment protocol. Receives: Behavioral: Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' qualitative experiences of the treatment
Exploration of patients' experiences and perceptions of the treatment through focus groups. No standardized scale or scoring is used. Discussions are audio-recorded, transcribed verbatim, and analyzed thematically to identify common themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Measured: At treatment inclusion, 6-months into treatment and 6-months post-treatment
Patients' qualitative experiences of the treatment
Exploration of patients' lived experiences and perceptions of the treatment through semi-structured interviews. No standardized scale or scoring is used. Interviews are transcribed verbatim and thematically analyzed. The outcome focuses on emergent themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Measured: At treatment initiation, 6-months into treatment and 6-months post-treatment
Clinicians' qualitative experiences of treatment
Exploration of therapists' lived experiences and perceptions of the treatment through semi-structured interviews. No standardized scale or scoring is used. Interviews are transcribed verbatim and thematically analyzed. The outcome focuses on emergent themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Measured: At 12 months after treatment initiation and again at 24 months after treatment initiation
Participants change in BPD symptom severity
The Borderline Symptom List-23 (BSL-23) is a self-report questionnaire consisting of 23 items designed to assess the severity of borderline symptoms. Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very strong"). The total score is calculated as the mean of all item scores, with a final score that ranges from 0 to 4. Higher scores indicate greater symptom severity.
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant changes in PTSD symptoms
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured clinical interview used to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms. It includes 30 items, of which 28 are rated on a 5-point scale ranging from 0 ("absent") to 4 ("extreme/incapacitating"). The total severity score ranges from 0 to 112 (sum of 28 rated items). Higher scores reflect greater PTSD symptom severity.
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant change in Dissociative experiences
Dissociative Experiences Scale (DES) is a 28-item self-report questionnaire designed to assess the frequency of dissociative experiences. Each item is scored as a percentage (0% to 100%) reflecting how often the experience occurs, and the total score corresponds to the mean of all item scores, ranging from 0 to 100. Higher scores indicate more frequent dissociative experiences.
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant diagnosis of borderline personality disorder
Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) is a semi-structured diagnostic interview used to assess personality disorders according to DSM-IV criteria. Only standardized questions to assess BPD were used. Each criterion is rated as present, absent, or subthreshold. The interview yields categorical diagnoses rather than a numerical score. A higher score represent a higher severity.
Measured: At treatment initation
Participant ADHD Screening
Adult ADHD Self-Report Scale (ASRS-v1.1) is an 18-item self-report questionnaire developed to screen for symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Part A of the scale consists of 6 items that are most predictive of ADHD. A screening is considered positive if the participant endorses 4 or more items in Part A above the defined threshold. Items are rated on a 5-point Likert scale from 0 ("never") to 4 ("very often"). A positive result suggests the need for further clinical evaluation.
Measured: At treatment initiation
Participant change in depression
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire used to assess the severity of depressive symptoms and the presence of suicidal ideation. Each item corresponds to a DSM criterion for major depressive disorder and is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity. Cut-off scores are as follows: 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression).
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant change in suicidal behaviors
Suicidal Behaviors Questionnaire-Revised (SBQ-R) is a 4-item self-report questionnaire used to assess risk for suicidal behavior. The items evaluate lifetime suicidal ideation and attempts, frequency of suicidal ideation over the past year, communication of suicidal intent, and self-perceived likelihood of future suicidal behavior. Each item has its own scoring scale, and total scores range from 3 to 18. Higher scores indicate greater risk of suicidal behavior.
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant alcohol use
Alcohol Use Disorders Identification Test (AUDIT-10) is a 10-item self-report questionnaire developed by the World Health Organization to screen for hazardous and harmful alcohol consumption. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 40. Higher scores indicate greater severity of alcohol use and associated risk.
Measured: At treatment initiation and 12-months into treatment
Patient impulsivity
UPPS-P Impulsive Behavior Scale is a self-report questionnaire designed to assess five distinct facets of impulsivity: Negative Urgency, Lack of Premeditation, Lack of Perseverance, Sensation Seeking, and Positive Urgency. The full version includes 59 items rated on a 4-point Likert scale from 1 ("agree strongly") to 4 ("disagree strongly"), with subscale scores and a total score calculated by summing relevant items. Higher scores reflect greater levels of impulsive traits.
Measured: At treatment initiation and 12-months into treatment
Participant and Clinician Working Alliance
Working Alliance Inventory - Short Form (WAI-SF) is a 12-item self-report questionnaire that assesses the quality of the therapeutic alliance between a client and therapist. Each item is rated on a 7-point Likert scale from 1 ("never") to 7 ("always"), yielding a total score ranging from 12 to 84. Higher scores indicate a stronger perceived working alliance.
Measured: Every 3 months during the first 12 months of treatment
Clinician treatment adherence to DBT-PTSD
Adherence Rating Scale for DBT-PTSD (ARS-DBT-PTSD) is a clinician-rated instrument designed to assess therapist adherence to the Dialectical Behavior Therapy protocol adapted for Posttraumatic Stress Disorder (DBT-PTSD). The scale includes a structured set of items evaluating specific therapeutic strategies, techniques, and session structure elements, each rated on a standardized scale (typically from 0 = "not implemented" to 2 or 3 = "fully implemented"). Higher scores reflect greater adherence to the DBT-PTSD treatment model.
Measured: Two sessions per therapist, scheduled at random points during the 12-month treatment period
Clinician competence for DBT-PTSD
Competence Rating Scale for DBT-PTSD is a clinician-rated instrument designed to assess the therapist's competence in delivering Dialectical Behavior Therapy adapted for Posttraumatic Stress Disorder (DBT-PTSD). It evaluates the quality of therapeutic delivery across several domains, such as treatment structure, application of DBT principles, interpersonal effectiveness, and responsiveness to trauma-related content. Each item is typically rated on a Likert-type scale (e.g., from 0 = "inadequate" to 6 = "excellent"). Higher scores indicate greater therapist competence in applying the DBT-PTSD model.
Measured: Two sessions per therapist, scheduled at random points during the 12-month treatment period
Participant change in functioning
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a standardized self-report questionnaire developed by the WHO to assess disability and functional impairment across six domains: cognition, mobility, self-care, getting along, life activities, and participation. The 36-item version rates each item on a 5-point Likert scale from 1 ("none") to 5 ("extreme or cannot do"), with total scores ranging from 36 to 180. Scores can be summed or converted into a standardized score from 0 to 100, where higher scores reflect greater disability and functional impairment.
Measured: At treatment initiation and every 3 months during the first 12 months of treatment
Participant ADHD Screening
Wender Utah Rating Scale (WURS) is a 50-item self-report questionnaire used to retrospectively assess symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in childhood. Each item is rated on a 5-point Likert scale from 0 ("not at all or never") to 4 ("very much or very often"), yielding a total score ranging from 0 to 200. A total score of 51 or higher is considered indicative of possible childhood ADHD.
Measured: At treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start22 Jan 2023
- Primary completion18 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Cailhol, Principal investigator, Ciusss de l'Est de Montréal, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123974
- Sponsor's protocol ID
- 2023-3031
- Acronym
- TRAUL
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Study of a Psychotherapy for Complex Trauma in a French-speaking Setting
- ClinicalTrials.gov ID
- NCT07123974
- Acronym / sponsor ID
- TRAUL / 2023-3031
- Conditions
- Borderline Personality Disorder (BPD), Complex Post-Traumatic Stress Disorder (CPTSD), Post-Traumatic Stress Disorder, PTSD
- Keywords
- Psychotherapy research, DBT-PTSD, Mixed-Methods study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 14 Aug 2025 (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.
Many individuals living with borderline personality disorder (BPD) have experienced childhood trauma, such as abuse or neglect. A significant number of them also meet the criteria for post-traumatic stress disorder (PTSD). However, standard psychotherapies often do not address both conditions at the same time, which can affect treatment outcomes.
A research team in Germany developed and validated a 45-week individual psychotherapy that has shown promising results for individuals coping with both BPD and PTSD. It has already been adapted and offered in English-speaking settings such as Toronto and Boston.
This study aims to adapt this therapy into French in Quebec. Over 24 months, we will conduct a mixed-methods observational study to evaluate changes in symptoms (BPD, PTSD, and other comorbidities) and in daily functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) | Experimental | Behavioral: Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD)Participants receive the Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) psychotherapy over 45 weekly individual outpatient sessions. All participants followed the same treatment protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PTSD according to the DSM caused by sexual or physical abuse up to the age of 18.
- Three or more criteria for borderline personality disorder (BPD) according to the SCID-II, including affective instability.
- Availability for one year of outpatient treatment (psychotherapy).
- Access to an email address usable for secure links to questionnaires.
- Fluent French-speaking.
Key exclusion criteria (6 listed)
- Psychotic disorder, bipolar I disorder, intellectual disability, or severe psychopathology requiring immediate care as determined by the treating psychiatrist.
- Severe suicide attempt within two months prior to the inclusion visit.
- Medical condition preventing inclusion (e.g., pregnancy).
- Highly unstable living situation (e.g., homelessness).
- Current substance dependence.
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 |
|---|---|---|
| Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD)DBT-PTSD is 45-week individual psychotherapy (DBT-PTSD) designed to treat adults presenting with both borderline personality disorder (BPD) and complex post-traumatic stress disorder (C-PTSD). The intervention integrates dialectical behavior therapy (DBT) skills, trauma-focused exposure-based interventions, and strategies from compassion-focused therapy and acceptance and commitment therapy. All participants will receive the full sequence of the therapy in outpatient settings, following the structured treatment protocol. | Behavioural | Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) |
Primary outcome
Patients' qualitative experiences of the treatment
Time frame: At treatment inclusion, 6-months into treatment and 6-months post-treatment
Exploration of patients' experiences and perceptions of the treatment through focus groups. No standardized scale or scoring is used. Discussions are audio-recorded, transcribed verbatim, and analyzed thematically to identify common themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Patients' qualitative experiences of the treatment
Time frame: At treatment initiation, 6-months into treatment and 6-months post-treatment
Exploration of patients' lived experiences and perceptions of the treatment through semi-structured interviews. No standardized scale or scoring is used. Interviews are transcribed verbatim and thematically analyzed. The outcome focuses on emergent themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Clinicians' qualitative experiences of treatment
Time frame: At 12 months after treatment initiation and again at 24 months after treatment initiation
Exploration of therapists' lived experiences and perceptions of the treatment through semi-structured interviews. No standardized scale or scoring is used. Interviews are transcribed verbatim and thematically analyzed. The outcome focuses on emergent themes related to perceived benefits, challenges, and overall acceptability of the treatment.
Participants change in BPD symptom severity
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
The Borderline Symptom List-23 (BSL-23) is a self-report questionnaire consisting of 23 items designed to assess the severity of borderline symptoms. Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very strong"). The total score is calculated as the mean of all item scores, with a final score that ranges from 0 to 4. Higher scores indicate greater symptom severity.
Participant changes in PTSD symptoms
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured clinical interview used to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms. It includes 30 items, of which 28 are rated on a 5-point scale ranging from 0 ("absent") to 4 ("extreme/incapacitating"). The total severity score ranges from 0 to 112 (sum of 28 rated items). Higher scores reflect greater PTSD symptom severity.
Participant change in Dissociative experiences
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
Dissociative Experiences Scale (DES) is a 28-item self-report questionnaire designed to assess the frequency of dissociative experiences. Each item is scored as a percentage (0% to 100%) reflecting how often the experience occurs, and the total score corresponds to the mean of all item scores, ranging from 0 to 100. Higher scores indicate more frequent dissociative experiences.
Participant diagnosis of borderline personality disorder
Time frame: At treatment initation
Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) is a semi-structured diagnostic interview used to assess personality disorders according to DSM-IV criteria. Only standardized questions to assess BPD were used. Each criterion is rated as present, absent, or subthreshold. The interview yields categorical diagnoses rather than a numerical score. A higher score represent a higher severity.
Participant ADHD Screening
Time frame: At treatment initiation
Adult ADHD Self-Report Scale (ASRS-v1.1) is an 18-item self-report questionnaire developed to screen for symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Part A of the scale consists of 6 items that are most predictive of ADHD. A screening is considered positive if the participant endorses 4 or more items in Part A above the defined threshold. Items are rated on a 5-point Likert scale from 0 ("never") to 4 ("very often"). A positive result suggests the need for further clinical evaluation.
Participant change in depression
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire used to assess the severity of depressive symptoms and the presence of suicidal ideation. Each item corresponds to a DSM criterion for major depressive disorder and is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity. Cut-off scores are as follows: 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression).
Participant change in suicidal behaviors
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
Suicidal Behaviors Questionnaire-Revised (SBQ-R) is a 4-item self-report questionnaire used to assess risk for suicidal behavior. The items evaluate lifetime suicidal ideation and attempts, frequency of suicidal ideation over the past year, communication of suicidal intent, and self-perceived likelihood of future suicidal behavior. Each item has its own scoring scale, and total scores range from 3 to 18. Higher scores indicate greater risk of suicidal behavior.
Participant alcohol use
Time frame: At treatment initiation and 12-months into treatment
Alcohol Use Disorders Identification Test (AUDIT-10) is a 10-item self-report questionnaire developed by the World Health Organization to screen for hazardous and harmful alcohol consumption. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 40. Higher scores indicate greater severity of alcohol use and associated risk.
Patient impulsivity
Time frame: At treatment initiation and 12-months into treatment
UPPS-P Impulsive Behavior Scale is a self-report questionnaire designed to assess five distinct facets of impulsivity: Negative Urgency, Lack of Premeditation, Lack of Perseverance, Sensation Seeking, and Positive Urgency. The full version includes 59 items rated on a 4-point Likert scale from 1 ("agree strongly") to 4 ("disagree strongly"), with subscale scores and a total score calculated by summing relevant items. Higher scores reflect greater levels of impulsive traits.
Participant and Clinician Working Alliance
Time frame: Every 3 months during the first 12 months of treatment
Working Alliance Inventory - Short Form (WAI-SF) is a 12-item self-report questionnaire that assesses the quality of the therapeutic alliance between a client and therapist. Each item is rated on a 7-point Likert scale from 1 ("never") to 7 ("always"), yielding a total score ranging from 12 to 84. Higher scores indicate a stronger perceived working alliance.
Clinician treatment adherence to DBT-PTSD
Time frame: Two sessions per therapist, scheduled at random points during the 12-month treatment period
Adherence Rating Scale for DBT-PTSD (ARS-DBT-PTSD) is a clinician-rated instrument designed to assess therapist adherence to the Dialectical Behavior Therapy protocol adapted for Posttraumatic Stress Disorder (DBT-PTSD). The scale includes a structured set of items evaluating specific therapeutic strategies, techniques, and session structure elements, each rated on a standardized scale (typically from 0 = "not implemented" to 2 or 3 = "fully implemented"). Higher scores reflect greater adherence to the DBT-PTSD treatment model.
Clinician competence for DBT-PTSD
Time frame: Two sessions per therapist, scheduled at random points during the 12-month treatment period
Competence Rating Scale for DBT-PTSD is a clinician-rated instrument designed to assess the therapist's competence in delivering Dialectical Behavior Therapy adapted for Posttraumatic Stress Disorder (DBT-PTSD). It evaluates the quality of therapeutic delivery across several domains, such as treatment structure, application of DBT principles, interpersonal effectiveness, and responsiveness to trauma-related content. Each item is typically rated on a Likert-type scale (e.g., from 0 = "inadequate" to 6 = "excellent"). Higher scores indicate greater therapist competence in applying the DBT-PTSD model.
Participant change in functioning
Time frame: At treatment initiation and every 3 months during the first 12 months of treatment
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a standardized self-report questionnaire developed by the WHO to assess disability and functional impairment across six domains: cognition, mobility, self-care, getting along, life activities, and participation. The 36-item version rates each item on a 5-point Likert scale from 1 ("none") to 5 ("extreme or cannot do"), with total scores ranging from 36 to 180. Scores can be summed or converted into a standardized score from 0 to 100, where higher scores reflect greater disability and functional impairment.
Participant ADHD Screening
Time frame: At treatment initiation
Wender Utah Rating Scale (WURS) is a 50-item self-report questionnaire used to retrospectively assess symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in childhood. Each item is rated on a 5-point Likert scale from 0 ("not at all or never") to 4 ("very much or very often"), yielding a total score ranging from 0 to 200. A total score of 51 or higher is considered indicative of possible childhood ADHD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Lionel Cailhol principal investigator
Ciusss de l'Est de Montréal, Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behaviour Therapy for Post-Traumatic Stress Disorder (DBT-PTSD) in people with Borderline Personality Disorder (BPD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 2025. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients' qualitative experiences of the treatment (time frame: At treatment inclusion, 6-months into treatment and 6-months post-treatment). The study lists 17 primary outcomes in all. 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 14 Aug 2025.