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

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. Identifier: NCT03833531
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : September 23, 2020
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):

Brief Summary:
The goal of PROSPER-C is to study effectiveness of ImRs compared to integrated SFT-ImRs in treatment-seeking, adult patients with comorbid PTSD and Cluster C Personality Disorder (CPD).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Avoidant Personality Disorder Dependent Personality Disorder Obsessive Compulsive Personality Disorder Behavioral: ImRS Behavioral: SFT 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 CPD, ImRs-only will be compared to integrated SFT-ImRs (PROSPER-C).

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.

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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 ImRs) to integrated PTSD-PD treatment (SFT-ImRS)in patients with PTSD and comorbid CPD.

The PTSD treatment (ImRS) specifically address the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months. Integrated PTSD-PD treatment consist of a PTSD treatment (ImRS) interwoven in a PD treatment (SFT) that takes at least one group-session per week, 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 (Cluster C) 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

Arm Intervention/treatment
Active Comparator: PTSD-ImRS
PTSD treatment
Behavioral: ImRS
ImRs is a PTSD treatment that specifically addresses the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months.

Experimental: Integrated SFT-ImRS
Integrated PTSD-PD treatment
Behavioral: ImRS
ImRs is a PTSD treatment that specifically addresses the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months.

Behavioral: SFT
SFT is a treatment for personality disorders that takes at least one group-session per week, for the duration of one year.

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. The symptoms 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. OQ-45 (Outcome Questionnaire-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. BDI (Beck depression inventory) [ 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. YSQ-75 (Young Schema Questionnaire - 75 Items) [ Time Frame: 12 months ]
    The YSQ-75 is a 75-item self-report questionnaire assesses 15 schemas: temporally stable, personal and interpersonal patterns of beliefs, feelings, sensations and thoughts. Items are rated on a 6-point scale ranging from 1 = Completely untrue of me to 6 = Describes me perfectly. There is evidence for adequate validity and reliability values. Although sparse, evidence suggests that dysfunctional schema reduction accompanies personality disorder symptom reduction after ST.

  13. SMI-118 (Schema Mode Inventory - 118 Items) [ Time Frame: 12 months ]
    The SMI-118 is a 118-item self-report questionnaire assessing 14 schema modes, defined as "those schemas or schema operations - adaptive or maladaptive - that are currently active for an individual". Each item is rated on a 6-point scale ranging from 1 (never) to 6 (always). Adequate psychometric properties have been reported. Although sparse, evidence suggests that dysfunctional schema mode reduction accompanies symptom reduction after ST. Similar to dysfunctional schema reduction, evidence suggests that dysfunctional schema mode reduction accompanies personality disorder symptom reduction after ST.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • Diagnosed with PTSD (309.81), and
  • Diagnosed with a cluster C personality disorder (avoidant 301.82, dependent 301.6, and/or obsessive-compulsive PD 301.4), or at least resp. 3, 4, and/ or 3 criteria of these PDs.

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.

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 identifier (NCT number): NCT03833531

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Contact: Arne van den End, Msc 0031-20-5457200
Contact: Inga Aarts, MSc 00-31-20-5457200

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Sinai Centrum Recruiting
Amstelveen, Noord-Holland, Netherlands, 1180EB
Contact: Arne van den End, MSc    0205457200   
Sponsors and Collaborators
Sinai Centrum, Arkin, The Netherlands
Amsterdam UMC, location VUmc
Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)
Ziekenhuis Amstelland
Meander Medisch Centrum
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Principal Investigator: Kathleen Thomaes, MD/PhD Sinai Centre
  Study Documents (Full-Text)

Documents provided by Arkin:
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Arkin Identifier: NCT03833531    
Other Study ID Numbers: PROSPER2018-C
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:
Imagination and rescripting therapy (ImRs)
Schema-Focused Therapy (SFT)
Integrated treatment
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Personality Disorders
Dependent Personality Disorder
Compulsive Personality Disorder
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders