<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833453</url>
  </required_header>
  <id_info>
    <org_study_id>PROSPER2018-B</org_study_id>
    <nct_id>NCT03833453</nct_id>
  </id_info>
  <brief_title>Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD</brief_title>
  <acronym>PROSPER-B</acronym>
  <official_title>Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkin</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinai Centrum, Arkin, The Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ziekenhuis Amstelland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Meander Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arkin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in&#xD;
      treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder&#xD;
      (BPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic stress disorder (PTSD) is highly comorbid with personality disorders (PD),&#xD;
      mainly borderline (BPD) and cluster C personality disorders (CPD). It is not clear yet what&#xD;
      treatment is most effective for those who suffer both PTSD and PD. There is growing&#xD;
      preference in clinicians for evidence-based PTSD treatments, such as Eye Movement&#xD;
      Desensitization and Reprocessing (EMDR) or Imagination and Rescripting (ImRs), because these&#xD;
      treatments are relative short, and there is some evidence that comorbid PD symptoms might&#xD;
      resolve as well. However, at least 30-44% PTSD patients do not sufficiently respond to PTSD&#xD;
      treatments or are excluded because of suicidality or self-harm. PD treatments are more&#xD;
      intensive than PTSD treatments, e.g. Dialectical Behavior Therapy (DBT) and Schema-Focused&#xD;
      Therapy (SFT) . There is some evidence that integrated PTSD-PD treatment is twice as&#xD;
      effective than PD treatment alone, but integrated PTSD-PD treatment is not yet directly&#xD;
      compared to PTSD treatment alone. This study will address this knowledge gap, including&#xD;
      secondary outcome measures on functioning, quality of life and cost-effectiveness.&#xD;
&#xD;
      For patients with comorbid PTSD and BPD, EMDR-only will be compared to integrated EMDR-DGT&#xD;
      (PROSPER-B).&#xD;
&#xD;
      Psychological (cognitive, affective, and relational) and neurobiological candidate predictors&#xD;
      and mediators of treatment outcome will be investigated through a machine-learning paradigm,&#xD;
      in order to develop a clinically useful and individual prediction instrument of treatment&#xD;
      outcome. Example predictors and mediators are educational level , working memory, hyper- and&#xD;
      hypo-arousal , therapeutic alliance and social support, resting state fMRI, an emotional face&#xD;
      task fMRI , cortisol levels from hair samples and (epi)genetic markers. For the&#xD;
      neurobiological prediction, a subgroup of patients will undergo MRI scans, as will healthy&#xD;
      controls as control subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">April 2, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized controlled trial comparing PTSD-treatment (EMDR) to integrated PTSD-PD-treatment (DBT-EMDR) in patients with PTSD and comorbid BPD.&#xD;
The PTSD treatment (EMDR) specifically address the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in a maximum period of 6 months. Integrated PTSD-PD-treatment consist of a PTSD treatment (EMDR) interwoven in a PD treatment (DBT) that takes at least one group- session per week, and one individual coaching session every two weeks, for the duration of one year.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Assessments will be performed by allocation-blind assessors. Upon seeing a participant for an assessment, assessors are instructed to immediately state that participants are not allowed to discuss aspects of the treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CAPS-5 (Clinician Administered PTSD Scale)</measure>
    <time_frame>12 months</time_frame>
    <description>The CAPS-5 is a structured diagnostic interview to assess the frequency and severity of DSM-5 PTSD symptoms. The interview consists of 30 items, with higher scores indicating more severe symptomatology. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. To meet the criteria for PTSD diagnoses, at least one Criterion B and one Criterion C symptom, and two criterion D and E symptoms are required. Furthermore, Criterion F and G should be met.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)</measure>
    <time_frame>12 months</time_frame>
    <description>The SCID-5-PD is a semi-structured interview to assess the presence and severity of the DSM-5 personality disorders. Diagnoses are made either categorically (present or absent) or dimensionally (summing the ratings for each symptom, which are rated 0, 1 or 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCL-5 (PTSD Checklist for DSM-5)</measure>
    <time_frame>12 months</time_frame>
    <description>The PCL-5 is a self-reported PTSD symptom scale. It consists of 20 items, scored 0 (&quot;not at all&quot;) to 4 (&quot;Extremely&quot;). This is summed for total self-reported PTSD-severity, range 0 (no self-reported PTSD-symptoms in the past month) to 80 (extreme self-reported PTSD-symptoms in the past month). There are subscales for the different PTSD symptom clusters; cluster B (question 1-5), C (6-7); D (8-14) and E (15-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome Questionnaire -45 (OQ-45)</measure>
    <time_frame>12 months</time_frame>
    <description>The OQ-45 is a self-report questionnaire that measures general functioning and physical complaints in the past week. It consists of 45 items; 25 items on psychiatric symptoms and 20 on interpersonal, occupational and social functioning. These are rated from 0 (&quot;Never&quot;) to 4 (&quot;Almost always&quot;). Some items need to be reversed in scoring. There are four subscales: Symptomatic Distress (25 items); Interpersonal Relationships (11 items) and Social Role (9 items). A higher score indicates worse functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck depression inventory (BDI)</measure>
    <time_frame>12 months</time_frame>
    <description>The BDI is a 21-item self-report questionnaire assessing the severity of depression. Each item consists of four statements indicating different levels of severity of a particular symptom experienced over the past week, ranging from low (0) to high (3) severity. Scores for all 21 items are summed to yield a single depression, with a maximum depression score of 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUDIT (Alcohol Use Disorders Identification Test)</measure>
    <time_frame>12 months</time_frame>
    <description>The AUDIT is a self-report questionnaire, with 10 items about alcohol use. These range from 0 (&quot;Never&quot;) to 4 (&quot;Daily&quot;). The items are summed to create a total score from 0 (no alcohol risk) to 40 (maximum alcohol risk). The first three questions are about alcohol consumption, question 4-6 about alcohol dependency and question 7-10 about alcohol related problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders)</measure>
    <time_frame>12 months</time_frame>
    <description>The SCID-5-S is a clinician administered semistructured clinical interview to assess DSM-5 disorders (but not personality disorders). It consists of in total 14 modules, comparable to the DSM-5. Patients are assessed on the disorder, resulting in a score of absent/present for each disorder. In this study, we use the modules current depressive episode, current manic episode, current persistent depressive disorder, delusions &amp; hallucinations, alcohol abuse, substance abuse, panic disorder, agoraphobia, specific phobia, generalized anxiety disorder, obsessive-compulsive disorder, current anorexia, bulimia and binge eating disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHODAS 2.0 (World Health Organization Disability Assessment Schedule)</measure>
    <time_frame>12 months</time_frame>
    <description>WHODAS 2.0 is a 36-item self-report questionnaire assessing the daily function of activity and participation within the 30 previous days, including the following six domains: Cognition, Mobility, Self-care, Getting along, Life activities and Participation. The responses on each item range from no difficulty (1) to extreme difficulty (5). Responses to the six dimensions are weighted and summed to create a total score between 0 (no disability) and 100 (complete disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels)</measure>
    <time_frame>12 months</time_frame>
    <description>The EQ-5D-5L measures health-related quality of life and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answer to each item results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, with higher numbers indicating more severe problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness)</measure>
    <time_frame>12 months</time_frame>
    <description>TiC-P is a self-report questionnaire assessing direct medical costs and productivity costs due to absence from work or reduced efficiency during work in patients with a mental disorder. The first part of the TiC-P includes 14 structured yes or no questions on the use of medical resources, each followed by a question on the volume of medical consumption. The second part includes five items on work absence, reduced efficiency at work and related productivity losses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NSSI (Non-suicidal Self-injury)</measure>
    <time_frame>12 months</time_frame>
    <description>The NSSI screener consists of 7 multiple-choice items assessing non-suicidal self-injury. In case of an affirmative responses to the item 'Have you ever done any of the following with the purpose of intentionally hurting yourself?' engagement in NSSI is determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAI-BOR (Personality Assessment Inventory- Borderline features scale)</measure>
    <time_frame>12 months</time_frame>
    <description>The Personality Assessment Inventory-Borderline Features (PAI-BOR) Scale is a self-report measure assessing the presence and severity of BPD. The BAI-BOR consists of four subscales of six items each, reflecting four main characteristics of BPD: affective instability, negative relationships, identity problems and self-harm. Each items is rated on a four-point scale, ranging from false (0) to very true (3). A total PAI-BOR score of 38 or more indicates the presence of significant BPD features, whereas a score of 60 or more indicates typical borderline personality functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STAS (State-Trait Anxiety Inventory)</measure>
    <time_frame>12 months</time_frame>
    <description>The State-Trait Anger Scale (STAS) is a 20-item questionnaire assessing state and trait anger. Both types of anger are assessed through 10 items, that are scored on a four-point rating scale, ranging from not at all (0) to very much so (4). The STAS has acceptable to strong internal consistency (Kroner &amp; Reddon, 1992).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DERS (Difficulties in Emotion Regulation Scale)</measure>
    <time_frame>12 months</time_frame>
    <description>The Difficulties in Emotion Regulation Scale (DERS) is a 41-item self-report measure to assess clinically relevant difficulties in emotion regulation. DERS items reflect difficulties within four dimensions of emotion regulation: awareness and understanding of emotions, acceptance of emotions, the ability to engage in goal-directed behaviour and to refrain from impulsive behaviour, and access to effective emotion regulation strategies. Items are scored on a five-point scale, ranging from almost never (1) to almost always (5). Although the Dutch version of DERS (DERS-NL) has not been validated yet, the original DERS showed high internal consistency, good test-retest reliability and adequate construct and predictive validity (Gratz &amp; Roemer, 2004).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Posttraumatic Stress Disorder (PTSD)</condition>
  <condition>Borderline Personality Disorder (BPD)</condition>
  <arm_group>
    <arm_group_label>PTSD-EMDR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PTSD treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Integrated DBT-EMDR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Integrated PTSD-PD-treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMDR</intervention_name>
    <description>EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.</description>
    <arm_group_label>Integrated DBT-EMDR</arm_group_label>
    <arm_group_label>PTSD-EMDR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DBT</intervention_name>
    <description>DBT is a treatment for personality disorders (PD) focused on emotion regulation. It takes at least one group-session per week, and one individual coaching session every two weeks, for the duration of one year.</description>
    <arm_group_label>Integrated DBT-EMDR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with PTSD (309.81), and&#xD;
&#xD;
          -  Diagnosed with a borderline personality disorder (301.83) or at least 4 BPD symptoms&#xD;
&#xD;
        To be eligible for the study, both patients and healthy controls (for the MRI scans) have&#xD;
        to:&#xD;
&#xD;
          -  Be aged between 18 and 65 years&#xD;
&#xD;
          -  Give written informed consent&#xD;
&#xD;
          -  Speak / understand Dutch sufficiently&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Current psychosis&#xD;
&#xD;
          -  Comorbidity interfering with treatment or randomisation (severe outward aggression,&#xD;
             antisocial PD, treatment interfering addiction or eating disorders, somatic problems)&#xD;
&#xD;
          -  Primary diagnosis of paranoid, schizoid, schizotypal, narcissistic, histrionic or&#xD;
             antisocial PD&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
        Additional exclusion criteria for the MRI substudy are:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metal implants (such as pacemakers, etc.);&#xD;
&#xD;
          -  Somatic disorders interfering with brain functioning&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  High dose use of benzodiazepines&#xD;
&#xD;
        For the healthy controls, current psychiatric diagnosis is an additional exclusion&#xD;
        criterion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Thomaes, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sinai Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aishah Snoek, MSc</last_name>
    <phone>0031-20-5457200</phone>
    <email>aishah.snoek@sinaicentrum.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inga Aarts, MSc</last_name>
    <phone>0031-20-5457200</phone>
    <email>inga.aarts@sinaicentrum.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sinai Centrum</name>
      <address>
        <city>Amstelveen</city>
        <state>Noord-Holand</state>
        <zip>1180EB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aishah Snoek, MSc</last_name>
      <phone>0031205457200</phone>
      <email>aishah.snoek@sinaicentrum.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
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  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>BPD</keyword>
  <keyword>Eye Movement Desensitisation and Reprocessing (EMDR)</keyword>
  <keyword>Dialectical Behavior Therapy (DBT)</keyword>
  <keyword>Integrated treatment</keyword>
  <keyword>Prediction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is no concrete plan for sharing yet, possibly neurobiological and (epi)genetic data will be shared in a later stage. Patients are asked to sign consent forms for future data sharing.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03833453/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833453
org study id: PROSPER2018-B
nct id: NCT03833453
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in
      treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder
      (BPD).
Posttraumatic stress disorder (PTSD) is highly comorbid with personality disorders (PD),
      mainly borderline (BPD) and cluster C personality disorders (CPD). It is not clear yet what
      treatment is most effective for those who suffer both PTSD and PD. There is growing
      preference in clinicians for evidence-based PTSD treatments, such as Eye Movement
      Desensitization and Reprocessing (EMDR) or Imagination and Rescripting (ImRs), because these
      treatments are relative short, and there is some evidence that comorbid PD symptoms might
      resolve as well. However, at least 30-44% PTSD patients do not sufficiently respond to PTSD
      treatments or are excluded because of suicidality or self-harm. PD treatments are more
      intensive than PTSD treatments, e.g. Dialectical Behavior Therapy (DBT) and Schema-Focused
      Therapy (SFT) . There is some evidence that integrated PTSD-PD treatment is twice as
      effective than PD treatment alone, but integrated PTSD-PD treatment is not yet directly
      compared to PTSD treatment alone. This study will address this knowledge gap, including
      secondary outcome measures on functioning, quality of life and cost-effectiveness.

      For patients with comorbid PTSD and BPD, EMDR-only will be compared to integrated EMDR-DGT
      (PROSPER-B).

      Psychological (cognitive, affective, and relational) and neurobiological candidate predictors
      and mediators of treatment outcome will be investigated through a machine-learning paradigm,
      in order to develop a clinically useful and individual prediction instrument of treatment
      outcome. Example predictors and mediators are educational level , working memory, hyper- and
      hypo-arousal , therapeutic alliance and social support, resting state fMRI, an emotional face
      task fMRI , cortisol levels from hair samples and (epi)genetic markers. For the
      neurobiological prediction, a subgroup of patients will undergo MRI scans, as will healthy
      controls as control subjects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled trial comparing PTSD-treatment (EMDR) to integrated PTSD-PD-treatment (DBT-EMDR) in patients with PTSD and comorbid BPD.
The PTSD treatment (EMDR) specifically address the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in a maximum period of 6 months. Integrated PTSD-PD-treatment consist of a PTSD treatment (EMDR) interwoven in a PD treatment (DBT) that takes at least one group- session per week, and one individual coaching session every two weeks, for the duration of one year.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Assessments will be performed by allocation-blind assessors. Upon seeing a participant for an assessment, assessors are instructed to immediately state that participants are not allowed to discuss aspects of the treatment.
measure: CAPS-5 (Clinician Administered PTSD Scale)
time frame: 12 months
description: The CAPS-5 is a structured diagnostic interview to assess the frequency and severity of DSM-5 PTSD symptoms. The interview consists of 30 items, with higher scores indicating more severe symptomatology. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. To meet the criteria for PTSD diagnoses, at least one Criterion B and one Criterion C symptom, and two criterion D and E symptoms are required. Furthermore, Criterion F and G should be met.
measure: SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)
time frame: 12 months
description: The SCID-5-PD is a semi-structured interview to assess the presence and severity of the DSM-5 personality disorders. Diagnoses are made either categorically (present or absent) or dimensionally (summing the ratings for each symptom, which are rated 0, 1 or 2).
measure: PCL-5 (PTSD Checklist for DSM-5)
time frame: 12 months
description: The PCL-5 is a self-reported PTSD symptom scale. It consists of 20 items, scored 0 ("not at all") to 4 ("Extremely"). This is summed for total self-reported PTSD-severity, range 0 (no self-reported PTSD-symptoms in the past month) to 80 (extreme self-reported PTSD-symptoms in the past month). There are subscales for the different PTSD symptom clusters; cluster B (question 1-5), C (6-7); D (8-14) and E (15-20).
measure: Outcome Questionnaire -45 (OQ-45)
time frame: 12 months
description: The OQ-45 is a self-report questionnaire that measures general functioning and physical complaints in the past week. It consists of 45 items; 25 items on psychiatric symptoms and 20 on interpersonal, occupational and social functioning. These are rated from 0 ("Never") to 4 ("Almost always"). Some items need to be reversed in scoring. There are four subscales: Symptomatic Distress (25 items); Interpersonal Relationships (11 items) and Social Role (9 items). A higher score indicates worse functioning.
measure: Beck depression inventory (BDI)
time frame: 12 months
description: The BDI is a 21-item self-report questionnaire assessing the severity of depression. Each item consists of four statements indicating different levels of severity of a particular symptom experienced over the past week, ranging from low (0) to high (3) severity. Scores for all 21 items are summed to yield a single depression, with a maximum depression score of 63.
measure: AUDIT (Alcohol Use Disorders Identification Test)
time frame: 12 months
description: The AUDIT is a self-report questionnaire, with 10 items about alcohol use. These range from 0 ("Never") to 4 ("Daily"). The items are summed to create a total score from 0 (no alcohol risk) to 40 (maximum alcohol risk). The first three questions are about alcohol consumption, question 4-6 about alcohol dependency and question 7-10 about alcohol related problems.
measure: SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders)
time frame: 12 months
description: The SCID-5-S is a clinician administered semistructured clinical interview to assess DSM-5 disorders (but not personality disorders). It consists of in total 14 modules, comparable to the DSM-5. Patients are assessed on the disorder, resulting in a score of absent/present for each disorder. In this study, we use the modules current depressive episode, current manic episode, current persistent depressive disorder, delusions & hallucinations, alcohol abuse, substance abuse, panic disorder, agoraphobia, specific phobia, generalized anxiety disorder, obsessive-compulsive disorder, current anorexia, bulimia and binge eating disorder.
measure: WHODAS 2.0 (World Health Organization Disability Assessment Schedule)
time frame: 12 months
description: WHODAS 2.0 is a 36-item self-report questionnaire assessing the daily function of activity and participation within the 30 previous days, including the following six domains: Cognition, Mobility, Self-care, Getting along, Life activities and Participation. The responses on each item range from no difficulty (1) to extreme difficulty (5). Responses to the six dimensions are weighted and summed to create a total score between 0 (no disability) and 100 (complete disability).
measure: EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels)
time frame: 12 months
description: The EQ-5D-5L measures health-related quality of life and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answer to each item results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, with higher numbers indicating more severe problems.
measure: Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness)
time frame: 12 months
description: TiC-P is a self-report questionnaire assessing direct medical costs and productivity costs due to absence from work or reduced efficiency during work in patients with a mental disorder. The first part of the TiC-P includes 14 structured yes or no questions on the use of medical resources, each followed by a question on the volume of medical consumption. The second part includes five items on work absence, reduced efficiency at work and related productivity losses.
measure: NSSI (Non-suicidal Self-injury)
time frame: 12 months
description: The NSSI screener consists of 7 multiple-choice items assessing non-suicidal self-injury. In case of an affirmative responses to the item 'Have you ever done any of the following with the purpose of intentionally hurting yourself?' engagement in NSSI is determined.
measure: PAI-BOR (Personality Assessment Inventory- Borderline features scale)
time frame: 12 months
description: The Personality Assessment Inventory-Borderline Features (PAI-BOR) Scale is a self-report measure assessing the presence and severity of BPD. The BAI-BOR consists of four subscales of six items each, reflecting four main characteristics of BPD: affective instability, negative relationships, identity problems and self-harm. Each items is rated on a four-point scale, ranging from false (0) to very true (3). A total PAI-BOR score of 38 or more indicates the presence of significant BPD features, whereas a score of 60 or more indicates typical borderline personality functioning.
measure: STAS (State-Trait Anxiety Inventory)
time frame: 12 months
description: The State-Trait Anger Scale (STAS) is a 20-item questionnaire assessing state and trait anger. Both types of anger are assessed through 10 items, that are scored on a four-point rating scale, ranging from not at all (0) to very much so (4). The STAS has acceptable to strong internal consistency (Kroner & Reddon, 1992).
measure: DERS (Difficulties in Emotion Regulation Scale)
time frame: 12 months
description: The Difficulties in Emotion Regulation Scale (DERS) is a 41-item self-report measure to assess clinically relevant difficulties in emotion regulation. DERS items reflect difficulties within four dimensions of emotion regulation: awareness and understanding of emotions, acceptance of emotions, the ability to engage in goal-directed behaviour and to refrain from impulsive behaviour, and access to effective emotion regulation strategies. Items are scored on a five-point scale, ranging from almost never (1) to almost always (5). Although the Dutch version of DERS (DERS-NL) has not been validated yet, the original DERS showed high internal consistency, good test-retest reliability and adequate construct and predictive validity (Gratz & Roemer, 2004).
arm group label: PTSD-EMDR
arm group type: Active Comparator
description: PTSD treatment
arm group label: Integrated DBT-EMDR
arm group type: Experimental
description: Integrated PTSD-PD-treatment
intervention type: Behavioral
intervention name: EMDR
description: EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.
arm group label: Integrated DBT-EMDR
arm group label: PTSD-EMDR
intervention type: Behavioral
intervention name: DBT
description: DBT is a treatment for personality disorders (PD) focused on emotion regulation. It takes at least one group-session per week, and one individual coaching session every two weeks, for the duration of one year.
arm group label: Integrated DBT-EMDR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Thomaes, MD/PhD
role: Principal Investigator
affiliation: Sinai Center
last name: Aishah Snoek, MSc
phone: 0031-20-5457200
email: aishah.snoek@sinaicentrum.nl
last name: Inga Aarts, MSc
phone: 0031-20-5457200
email: inga.aarts@sinaicentrum.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
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PMID: 15677582
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citation: Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
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responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: Undecided
ipd description: There is no concrete plan for sharing yet, possibly neurobiological and (epi)genetic data will be shared in a later stage. Patients are asked to sign consent forms for future data sharing.
provided document: 