Clinical trial NCT03833531: Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD
Official title: Prediction and Outcome Study in PTSD and (Cluster C) Personality Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Avoidant Personality Disorder
Dependent Personality Disorder
Obsessive Compulsive Personality Disorder
Keywords: PTSD
CPD
Imagination and rescripting therapy (ImRs)
Schema-Focused Therapy (SFT)
Integrated treatment
Prediction
Lead sponsor: Arkin
Sponsor class: INDUSTRY
Collaborators: name: Sinai Centrum, Arkin, The Netherlands
name: Amsterdam UMC, location VUmc
name: Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)
name: Ziekenhuis Amstelland
name: Meander Medisch Centrum
First posted: 2019-02-07
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CAPS-5 (Clinician Administered PTSD Scale)
timeFrame: 12 months
Secondary outcomes:
measure: SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)
timeFrame: 12 months
measure: PCL-5 (PTSD Checklist for DSM-5)
timeFrame: 12 months
measure: OQ-45 (Outcome Questionnaire-45)
timeFrame: 12 months
measure: BDI (Beck depression inventory)
timeFrame: 12 months
measure: AUDIT (Alcohol Use Disorders Identification Test)
timeFrame: 12 months
measure: SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders)
timeFrame: 12 months
measure: WHODAS 2.0 (World Health Organization Disability Assessment Schedule)
timeFrame: 12 months
measure: EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels)
timeFrame: 12 months
measure: Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness)
timeFrame: 12 months
measure: NSSI (Non-Suicidal Self-Injury)
timeFrame: 12 months
measure: PAI-BOR (Personality Assessment Inventory- Borderline features scale)
timeFrame: 12 months
measure: YSQ-75 (Young Schema Questionnaire - 75 Items)
timeFrame: 12 months
measure: SMI-118 (Schema Mode Inventory - 118 Items)
timeFrame: 12 months
Other outcomes:
Locations:
city: Amstelveen
country: Netherlands
facility: Sinai Centrum
state: Noord-Holland
Study officials:
affiliation: Sinai Centre
name: Kathleen Thomaes, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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