Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03833531
Other study ID # PROSPER2018-C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 5, 2023

Study information

Verified date June 2023
Source Arkin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date May 5, 2023
Est. primary completion date January 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Sinai Centrum Amstelveen Noord-Holland

Sponsors (6)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 SCID-5-PD (Structured Interview for DSM-5 Personality Disorders) 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). 12 months
Secondary PCL-5 (PTSD Checklist for DSM-5) 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
Secondary OQ-45 (Outcome Questionnaire-45) 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
Secondary BDI (Beck depression inventory) 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
Secondary AUDIT (Alcohol Use Disorders Identification Test) 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
Secondary SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders) 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
Secondary WHODAS 2.0 (World Health Organization Disability Assessment Schedule) 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
Secondary EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels) 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
Secondary Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness) 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
Secondary NSSI (Non-Suicidal Self-Injury) 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
Secondary PAI-BOR (Personality Assessment Inventory- Borderline features scale) 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
Secondary YSQ-75 (Young Schema Questionnaire - 75 Items) 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. 12 months
Secondary SMI-118 (Schema Mode Inventory - 118 Items) 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. 12 months
See also
  Status Clinical Trial Phase
Completed NCT01443182 - Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma N/A
Completed NCT01507948 - Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD) N/A
Completed NCT02911285 - NAC for Treating Comorbid PTSD and SUD Phase 2
Recruiting NCT02234076 - A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma N/A
Completed NCT01729026 - A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD) Early Phase 1
Completed NCT01446146 - Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice N/A
Completed NCT01464892 - Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma N/A
Completed NCT01406834 - Treatment for the Mental Health Impact of Killing in War N/A
Active, not recruiting NCT03283163 - Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD N/A
Completed NCT02442843 - Non Invasive Brain Stimulation for PTSD Early Phase 1
Completed NCT01888653 - Attention-Bias Modification Treatment for PTSD N/A
Completed NCT01474057 - DElivery of Self Training and Education for Stressful Situations-Primary Care Version Phase 2
Completed NCT00672776 - Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD) Phase 4
Completed NCT03641924 - Cognition and Psychotherapy in PTSD
Completed NCT02397889 - Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD) Phase 2/Phase 3
Completed NCT02322047 - Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders Phase 2
Completed NCT00320138 - Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel Phase 1
Recruiting NCT03833453 - Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD N/A
Completed NCT03529435 - Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD N/A
Completed NCT01492348 - Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial N/A