- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833453
Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD (PROSPER-B)
Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aishah Snoek, MSc
- Phone Number: 0031-20-5457200
- Email: aishah.snoek@sinaicentrum.nl
Study Contact Backup
- Name: Inga Aarts, MSc
- Phone Number: 0031-20-5457200
- Email: inga.aarts@sinaicentrum.nl
Study Locations
-
-
Noord-Holand
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Amstelveen, Noord-Holand, Netherlands, 1180EB
- Recruiting
- Sinai Centrum
-
Contact:
- Aishah Snoek, MSc
- Phone Number: 0031205457200
- Email: aishah.snoek@sinaicentrum.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PTSD-EMDR
PTSD treatment
|
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.
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Experimental: Integrated DBT-EMDR
Integrated PTSD-PD-treatment
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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 months
|
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).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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).
|
12 months
|
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).
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Thomaes, MD/PhD, Sinai Center
Publications and helpful links
General Publications
- Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Stoffers JM, Vollm BA, Rucker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2.
- Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214. Erratum In: Am J Psychiatry. 2005 Apr;162(4):832. Am J Psychiatry. 2006 Feb;163(2):330.
- Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
- Harned MS, Korslund KE, Linehan MM. A pilot randomized controlled trial of Dialectical Behavior Therapy with and without the Dialectical Behavior Therapy Prolonged Exposure protocol for suicidal and self-injuring women with borderline personality disorder and PTSD. Behav Res Ther. 2014 Apr;55:7-17. doi: 10.1016/j.brat.2014.01.008. Epub 2014 Feb 11.
- Ehlers A, Clark DM, Hackmann A, McManus F, Fennell M. Cognitive therapy for post-traumatic stress disorder: development and evaluation. Behav Res Ther. 2005 Apr;43(4):413-31. doi: 10.1016/j.brat.2004.03.006.
- Lanius RA, Vermetten E, Loewenstein RJ, Brand B, Schmahl C, Bremner JD, Spiegel D. Emotion modulation in PTSD: Clinical and neurobiological evidence for a dissociative subtype. Am J Psychiatry. 2010 Jun;167(6):640-7. doi: 10.1176/appi.ajp.2009.09081168. Epub 2010 Apr 1.
- Nijdam MJ, de Vries GJ, Gersons BP, Olff M. Response to psychotherapy for posttraumatic stress disorder: the role of pretreatment verbal memory performance. J Clin Psychiatry. 2015 Aug;76(8):e1023-8. doi: 10.4088/JCP.14m09438.
- van Rooij SJ, Kennis M, Vink M, Geuze E. Predicting Treatment Outcome in PTSD: A Longitudinal Functional MRI Study on Trauma-Unrelated Emotional Processing. Neuropsychopharmacology. 2016 Mar;41(4):1156-65. doi: 10.1038/npp.2015.257. Epub 2015 Aug 20.
- Cloitre M, Stovall-McClough KC, Miranda R, Chemtob CM. Therapeutic alliance, negative mood regulation, and treatment outcome in child abuse-related posttraumatic stress disorder. J Consult Clin Psychol. 2004 Jun;72(3):411-6. doi: 10.1037/0022-006X.72.3.411.
- Bryant RA, Felmingham K, Kemp A, Das P, Hughes G, Peduto A, Williams L. Amygdala and ventral anterior cingulate activation predicts treatment response to cognitive behaviour therapy for post-traumatic stress disorder. Psychol Med. 2008 Apr;38(4):555-61. doi: 10.1017/S0033291707002231. Epub 2007 Nov 16.
- Brewin CR, Andrews B, Valentine JD. Meta-analysis of risk factors for posttraumatic stress disorder in trauma-exposed adults. J Consult Clin Psychol. 2000 Oct;68(5):748-66. doi: 10.1037//0022-006x.68.5.748.
- 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.
- Clarke SB, Rizvi SL, Resick PA. Borderline personality characteristics and treatment outcome in cognitive-behavioral treatments for PTSD in female rape victims. Behav Ther. 2008 Mar;39(1):72-8. doi: 10.1016/j.beth.2007.05.002. Epub 2007 Oct 22.
- Frias A, Palma C. Comorbidity between post-traumatic stress disorder and borderline personality disorder: a review. Psychopathology. 2015;48(1):1-10. doi: 10.1159/000363145. Epub 2014 Sep 9.
- Feeny NC, Zoellner LA, Foa EB. Treatment outcome for chronic PTSD among female assault victims with borderline personality characteristics: a preliminary examination. J Pers Disord. 2002 Feb;16(1):30-40. doi: 10.1521/pedi.16.1.30.22555.
- Hembree EA, Cahill SP, Foa EB. Impact of personality disorders on treatment outcome for female assault survivors with chronic posttraumatic stress disorder. J Pers Disord. 2004 Feb;18(1):117-27. doi: 10.1521/pedi.18.1.117.32767.
- Kredlow MA, Szuhany KL, Lo S, Xie H, Gottlieb JD, Rosenberg SD, Mueser KT. Cognitive behavioral therapy for posttraumatic stress disorder in individuals with severe mental illness and borderline personality disorder. Psychiatry Res. 2017 Mar;249:86-93. doi: 10.1016/j.psychres.2016.12.045. Epub 2017 Jan 4.
- Roberts BW, Luo J, Briley DA, Chow PI, Su R, Hill PL. A systematic review of personality trait change through intervention. Psychol Bull. 2017 Feb;143(2):117-141. doi: 10.1037/bul0000088. Epub 2017 Jan 5.
- Raabe S, Ehring T, Marquenie L, Olff M, Kindt M. Imagery Rescripting as stand-alone treatment for posttraumatic stress disorder related to childhood abuse. J Behav Ther Exp Psychiatry. 2015 Sep;48:170-6. doi: 10.1016/j.jbtep.2015.03.013. Epub 2015 Apr 4.
- Arntz A, Tiesema M, Kindt M. Treatment of PTSD: a comparison of imaginal exposure with and without imagery rescripting. J Behav Ther Exp Psychiatry. 2007 Dec;38(4):345-70. doi: 10.1016/j.jbtep.2007.10.006. Epub 2007 Oct 26.
- Farrell JM, Shaw IA, Webber MA. A schema-focused approach to group psychotherapy for outpatients with borderline personality disorder: a randomized controlled trial. J Behav Ther Exp Psychiatry. 2009 Jun;40(2):317-28. doi: 10.1016/j.jbtep.2009.01.002. Epub 2009 Jan 14. Erratum In: J Behav Ther Exp Psychiatry. 2018 Apr 18;:
- Aarts I, Vriend C, Snoek A, van den End A, Blankers M, Beekman ATF, Dekker J, van den Heuvel OA, Thomaes K. Neural correlates of treatment effect and prediction of treatment outcome in patients with PTSD and comorbid personality disorder: study design. Borderline Personal Disord Emot Dysregul. 2021 May 5;8(1):13. doi: 10.1186/s40479-021-00156-8.
- Snoek A, Beekman ATF, Dekker J, Aarts I, van Grootheest G, Blankers M, Vriend C, van den Heuvel O, Thomaes K. A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of eye movement desensitization and reprocessing (EMDR) and integrated EMDR-Dialectical Behavioural Therapy (DBT) in the treatment of patients with post-traumatic stress disorder and comorbid (Sub)clinical borderline personality disorder: study design. BMC Psychiatry. 2020 Aug 6;20(1):396. doi: 10.1186/s12888-020-02713-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROSPER2018-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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