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Posttraumatic Stress Disorder (PTSD)PROSPER-CNCT03833531

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

A study testing ImRS and SFT in people with Posttraumatic Stress Disorder (PTSD) and Avoidant Personality Disorder, run by Arkin at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
ImRS and SFT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteNetherlands
Study dates
1 Jun 2018to 5 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Sinai Centrum

    Amstelveen, North Holland, 1180EB

Other trials in Netherlands

About this study

Official title: Prediction and Outcome Study in PTSD and (Cluster C) Personality Disorders

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).

Read the 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.

Being tested
ImRS, SFT
Keywords
PTSD, CPD, Imagination and rescripting therapy (ImRs), Schema-Focused Therapy (SFT), Integrated treatment, Prediction
Medical subject headings
Stress Disorders, Post-Traumatic, Personality Disorders, Dependent Personality Disorder, Compulsive Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImRSBehavioural

    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.

  • SFTBehavioural

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

Study groups in NCT03833531
Study groupRoleWhat they receive
PTSD-ImRSActive comparatorPTSD treatment
Receives: Behavioral: ImRS
Integrated SFT-ImRSExperimentalIntegrated PTSD-PD treatment
Receives: Behavioral: ImRS; Behavioral: SFT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (13)

  1. 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).

    Measured: 12 months

  2. 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).

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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).

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

  10. 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.

    Measured: 12 months

  11. 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.

    Measured: 12 months

  12. 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.

    Measured: 12 months

  13. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start1 Jun 2018
  3. Primary completion9 Jan 2023
  4. Study completion5 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833531
Sponsor's protocol ID
PROSPER2018-C
Acronym
PROSPER-C
Status last verified
Jun 2023
First submitted
24 Jan 2019
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 15677582

  • 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.

    PubMed 24562087

  • 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.

    PubMed 15701354

  • 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.

    PubMed 20360318

  • 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.

    PubMed 26335088

  • 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.

    PubMed 26289143

  • 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.

    PubMed 15279525

  • 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.

    PubMed 18005496

  • 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.

    PubMed 11068961

  • 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.

    PubMed 17636720

  • 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.

    PubMed 24338345

  • 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.

    PubMed 18328872

  • 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.

    PubMed 25227722

  • 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.

    PubMed 11881159

  • 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.

    PubMed 15061348

Questions about this trial

What is this clinical trial studying?

A study testing ImRS and SFT in people with Posttraumatic Stress Disorder (PTSD) and Avoidant Personality Disorder, run by Arkin at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CAPS-5 (Clinician Administered PTSD Scale) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03833531, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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