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

Arkin

Status: Completed

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

Treatments: Behavioral: SFT; Behavioral: ImRS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03833531

PROSPER2018-C

Details and patient eligibility

About

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).

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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131 participants in 2 patient groups

PTSD-ImRS

Active Comparator group

Description:

PTSD treatment

Treatment:

Behavioral: ImRS

Integrated SFT-ImRS

Experimental group

Description:

Integrated PTSD-PD treatment

Treatment:

Behavioral: SFT

Behavioral: ImRS