Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD
NCT ID: NCT03833453
Last Updated: 2020-09-23
Study Results
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Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2018-06-01
2023-04-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The PTSD treatment (EMDR) specifically address the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in a maximum period of 6 months. Integrated PTSD-PD-treatment consist of a PTSD treatment (EMDR) interwoven in a PD treatment (DBT) that takes at least one group- session per week, and one individual coaching session every two weeks, for the duration of one year.
TREATMENT
DOUBLE
Study Groups
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PTSD-EMDR
PTSD treatment
EMDR
EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.
Integrated DBT-EMDR
Integrated PTSD-PD-treatment
EMDR
EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.
DBT
DBT is a treatment for personality disorders (PD) focused on emotion regulation. It takes at least one group-session per week, and one individual coaching session every two weeks, for the duration of one year.
Interventions
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EMDR
EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.
DBT
DBT is a treatment for personality disorders (PD) focused on emotion regulation. It takes at least one group-session per week, and one individual coaching session every two weeks, for the duration of one year.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Sinai Centrum, Arkin, The Netherlands
UNKNOWN
Amsterdam UMC, location VUmc
OTHER
Stichting Steunfonds Joodse Geestelijke Gezondheidszorg (SSF JGG)
UNKNOWN
Ziekenhuis Amstelland
OTHER
Meander Medisch Centrum
OTHER
Arkin
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Thomaes, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Sinai Center
Locations
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Sinai Centrum
Amstelveen, Noord-Holand, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PROSPER2018-B
Identifier Type: -
Identifier Source: org_study_id
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