Implementing a Therapy for Complex Trauma in French-Speaking Settings

Primary outcomes

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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).

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.