Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD
Condition: Posttraumatic Stress Disorder (PTSD); Avoidant Personality Disorder; Dependent Personality Disorder; Obsessive Compulsive Personality Disorder
MeSH terms: Stress Disorders, Post-Traumatic; Personality Disorders; Compulsive Personality Disorder; Dependent Personality Disorder
Study type: Interventional

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.
    

Intervention name(s): ImRS; SFT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 is a treatment for personality disorders that takes at least one group-session per week, for the duration of one year.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; CPD; Imagination and rescripting therapy (ImRs); Schema-Focused Therapy (SFT); Integrated treatment; Prediction