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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

— PROSPER-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833531
• Other study ID #: PROSPER2018-C
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Avoidant Personality Disorder
• Dependent Personality Disorder
• Obsessive Compulsive Personality Disorder
• Personality Disorders
• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic

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)

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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 all — Click 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

External Links

•   Landelijke Stuurgroep Multidisciplinaire Richtlijnontwikkeling (2008). Multidisciplinaire Richtlijn Persoonlijkheidsstoornissen, Trimbos Instituut, Utrecht.
•   Multidisciplinaire richtlijn Angststoornissen (Derde revisie). Richtlijn voor de diagnostiek, behandeling en begeleiding van volwassen patiënten met een angststoornis. Trimbos-instituut.