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

  • STATUS
    Recruiting
  • End date
    Apr 2, 2023
  • participants needed
    126
  • sponsor
    Arkin
Updated on 25 January 2021

Summary

The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).

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 BPD, EMDR-only will be compared to integrated EMDR-DGT (PROSPER-B).

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.

Details
Condition Borderline Personality Disorder, Post-Traumatic Stress Disorder, Post-Traumatic Stress Disorders, PTSD, borderline personality
Treatment DBT, EMDR
Clinical Study IdentifierNCT03833453
SponsorArkin
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Borderline Personality Disorder or Post-Traumatic Stress Disorders or Post-Traumatic Stress Disorder?
Do you have any of these conditions: Post-Traumatic Stress Disorders or Post-Traumatic Stress Disorder or PTSD or Borderline Personality Disorder or borderline personality?
Diagnosed with PTSD (309.81), and
Diagnosed with a borderline personality disorder (301.83) or at least 4 BPD symptoms
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note