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Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD (PROSPER-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833453
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
Sinai Centrum, Arkin, The Netherlands
Amsterdam UMC, location VUmc
Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)
Ziekenhuis Amstelland
Meander Medisch Centrum
Information provided by (Responsible Party):
Arkin

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Borderline Personality Disorder (BPD) Behavioral: EMDR Behavioral: DBT Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
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.
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.
Primary Purpose: Treatment
Official Title: Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2, 2022
Estimated Study Completion Date : April 2, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PTSD-EMDR
PTSD treatment
 Behavioral: EMDR
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.
Experimental: Integrated DBT-EMDR
Integrated PTSD-PD-treatment
 Behavioral: EMDR
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.

Behavioral: DBT
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.


Outcome Measures
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Primary Outcome Measures :
  1. CAPS-5 (Clinician Administered PTSD Scale) [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. SCID-5-PD (Structured Interview for DSM-5 Personality Disorders) [ Time Frame: 12 months ]
    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).

  2. PCL-5 (PTSD Checklist for DSM-5) [ Time Frame: 12 months ]
    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).

  3. Outcome Questionnaire -45 (OQ-45) [ Time Frame: 12 months ]
    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.

  4. Beck depression inventory (BDI) [ Time Frame: 12 months ]
    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.

  5. AUDIT (Alcohol Use Disorders Identification Test) [ Time Frame: 12 months ]
    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.

  6. SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders) [ Time Frame: 12 months ]
    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.

  7. WHODAS 2.0 (World Health Organization Disability Assessment Schedule) [ Time Frame: 12 months ]
    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).

  8. EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels) [ Time Frame: 12 months ]
    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.

  9. Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness) [ Time Frame: 12 months ]
    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.

  10. NSSI (Non-suicidal Self-injury) [ Time Frame: 12 months ]
    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.

  11. PAI-BOR (Personality Assessment Inventory- Borderline features scale) [ Time Frame: 12 months ]
    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.

  12. STAS (State-Trait Anxiety Inventory) [ Time Frame: 12 months ]
    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).

  13. DERS (Difficulties in Emotion Regulation Scale) [ Time Frame: 12 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with PTSD (309.81), and
  • Diagnosed with a borderline personality disorder (301.83) or at least 4 BPD symptoms

To be eligible for the study, both patients and healthy controls (for the MRI scans) have to:

  • Be aged between 18 and 65 years
  • Give written informed consent
  • Speak / understand Dutch sufficiently

Exclusion criteria:

  • Current psychosis
  • Comorbidity interfering with treatment or randomisation (severe outward aggression, antisocial PD, treatment interfering addiction or eating disorders, somatic problems)
  • Primary diagnosis of paranoid, schizoid, schizotypal, narcissistic, histrionic or antisocial PD
  • Mental retardation

Additional exclusion criteria for the MRI substudy are:

  • Pregnancy
  • Metal implants (such as pacemakers, etc.);
  • Somatic disorders interfering with brain functioning
  • Claustrophobia
  • High dose use of benzodiazepines

For the healthy controls, current psychiatric diagnosis is an additional exclusion criterion.

Contacts and Locations
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Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833453


Contacts
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Contact: Aishah Snoek, MSc 0031-20-5457200 aishah.snoek@sinaicentrum.nl
Contact: Inga Aarts, MSc 0031-20-5457200 inga.aarts@sinaicentrum.nl

Locations
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Netherlands
Sinai Centrum Recruiting
Amstelveen, Noord-Holand, Netherlands, 1180EB
Contact: Aishah Snoek, MSc    0031205457200    aishah.snoek@sinaicentrum.nl   
Sponsors and Collaborators
Arkin
Sinai Centrum, Arkin, The Netherlands
Amsterdam UMC, location VUmc
Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)
Ziekenhuis Amstelland
Meander Medisch Centrum
Investigators
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Principal Investigator: Kathleen Thomaes, MD/PhD Sinai Center
  Study Documents (Full-Text)

Documents provided by Arkin:
Study Protocol and Statistical Analysis Plan  [PDF] June 22, 2020

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arkin
ClinicalTrials.gov Identifier: NCT03833453    
Other Study ID Numbers: PROSPER2018-B
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arkin:
PTSD
BPD
Eye Movement Desensitisation and Reprocessing (EMDR)
 Dialectical Behavior Therapy (DBT)
Integrated treatment
Prediction
Additional relevant MeSH terms:
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Disease
Stress Disorders, Post-Traumatic
Personality Disorders
Borderline Personality Disorder
 Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders