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

NCT03833453 | Unknown

• 1 other identifier: PROSPER2018-B
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Posttraumatic Stress Disorder (PTSD); Borderline Personality Disorder (BPD)

Keywords

PTSD; BPD; Eye Movement Desensitisation and Reprocessing (EMDR); Dialectical Behavior Therapy (DBT); Integrated treatment; Prediction

Outcome Measures

Primary Outcomes (1)

• CAPS-5 (Clinician Administered PTSD Scale)

  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 Outcomes (13)

• SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)

  12 months

• PCL-5 (PTSD Checklist for DSM-5)

  12 months

• Outcome Questionnaire -45 (OQ-45)

  12 months

• Beck depression inventory (BDI)

  12 months

• AUDIT (Alcohol Use Disorders Identification Test)

  12 months

Study Arms (2)

PTSD-EMDR

ACTIVE COMPARATOR

PTSD treatment

Behavioral: EMDR

Integrated DBT-EMDR

EXPERIMENTAL

Integrated PTSD-PD-treatment

Behavioral: EMDR; Behavioral: DBT

Interventions

EMDR BEHAVIORAL

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.

Integrated DBT-EMDR; PTSD-EMDR

DBT BEHAVIORAL

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.

Integrated DBT-EMDR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Sinai Centrum

Amstelveen, Noord-Holand, 1180EB, Netherlands

RECRUITING

Related Publications (26)

• 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.

  PMID: 15677582 BACKGROUND

• 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.

  PMID: 24562087 BACKGROUND

• 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.

  PMID: 15701354 BACKGROUND

• 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.

  PMID: 20360318 BACKGROUND

• 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.

  PMID: 26335088 BACKGROUND

• 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.

  PMID: 26289143 BACKGROUND

• 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.

  PMID: 15279525 BACKGROUND

• 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.

  PMID: 18005496 BACKGROUND

• 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.

  PMID: 11068961 BACKGROUND

• 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.

  PMID: 17636720 BACKGROUND

• 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.

  PMID: 24338345 BACKGROUND

• 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.

  PMID: 18328872 BACKGROUND

• 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.

  PMID: 11881159 BACKGROUND

• 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.

  PMID: 25227722 BACKGROUND

• 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.

  PMID: 15061348 BACKGROUND

• 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.

  PMID: 28054797 BACKGROUND

• 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.

  PMID: 28086181 BACKGROUND

• 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.

  PMID: 22895952 BACKGROUND

• 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.

  PMID: 25898289 BACKGROUND

• 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.

  PMID: 18005935 BACKGROUND

• 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.

  PMID: 19176222 BACKGROUND

• Kuhner C, de Waal M, Steenkamp L, van Zwol I, Goudriaan A, Thomaes K. The impact of types of childhood maltreatment on the severity of PTSD and comorbid personality disorder symptoms. Eur J Psychotraumatol. 2025 Dec;16(1):2491172. doi: 10.1080/20008066.2025.2491172. Epub 2025 Apr 22.

  PMID: 40261043 DERIVED

• Snoek A, Edens R, van Ballegooijen W, Dekker J, Beekman AT, Thomaes K. A network perspective on posttraumatic stress disorder and comorbid borderline personality disorder symptoms. Eur J Psychotraumatol. 2024;15(1):2367815. doi: 10.1080/20008066.2024.2367815. Epub 2024 Jul 3.

  PMID: 38957149 DERIVED

• 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.

  PMID: 33947471 DERIVED

• 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.

  PMID: 32762677 DERIVED

• 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.

  PMID: 32368793 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Borderline Personality Disorder

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kathleen Thomaes, MD/PhD

  Sinai Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aishah Snoek, MSc

CONTACT

0031-20-5457200; aishah.snoek@sinaicentrum.nl

Inga Aarts, MSc

CONTACT

0031-20-5457200; inga.aarts@sinaicentrum.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 7, 2019
• Study Start: June 1, 2018
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2023
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

NL (1)