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

Sponsor

Arkin (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03833453

Collaborator

Sinai Centrum, Arkin, The Netherlands (Other), Amsterdam UMC, location VUmc (Other), Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG) (Other), Ziekenhuis Amstelland (Other), Meander Medisch Centrum (Other)

126

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Jun 1, 2018

Anticipated Primary Completion Date :

Apr 2, 2022

Anticipated Study Completion Date :

Apr 2, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

CAPS-5 (Clinician Administered PTSD Scale) [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

SCID-5-PD (Structured Interview for DSM-5 Personality Disorders) [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).
PCL-5 (PTSD Checklist for DSM-5) [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).
Outcome Questionnaire -45 (OQ-45) [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.
Beck depression inventory (BDI) [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.
AUDIT (Alcohol Use Disorders Identification Test) [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.
SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders) [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.
WHODAS 2.0 (World Health Organization Disability Assessment Schedule) [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).
EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels) [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.
Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness) [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.
NSSI (Non-suicidal Self-injury) [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.
PAI-BOR (Personality Assessment Inventory- Borderline features scale) [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.
STAS (State-Trait Anxiety Inventory) [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).
DERS (Difficulties in Emotion Regulation Scale) [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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