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

NCT ID: NCT03833531

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-05-05

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Avoidant Personality Disorder; Dependent Personality Disorder; Obsessive Compulsive Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PTSD-ImRS

PTSD treatment

Group Type: ACTIVE_COMPARATOR

ImRS

Intervention Type: BEHAVIORAL

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.

Integrated SFT-ImRS

Integrated PTSD-PD treatment

Group Type: EXPERIMENTAL

ImRS

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

SFT

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

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinai Centrum, Arkin, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)

UNKNOWN

Sponsor Role: collaborator

Ziekenhuis Amstelland

OTHER

Sponsor Role: collaborator

Meander Medisch Centrum

OTHER

Sponsor Role: collaborator

Arkin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Thomaes, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Centre

Locations

Sinai Centrum

Amstelveen, North Holland, Netherlands

Countries

Netherlands

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PROSPER2018-C

Identifier Type: -

Identifier Source: org_study_id