Status:
COMPLETED
Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD
Lead Sponsor:
Arkin
Collaborating Sponsors:
Sinai Centrum, Arkin, The Netherlands
Amsterdam UMC, location VUmc
Conditions:
Posttraumatic Stress Disorder (PTSD)
Avoidant Personality Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT03833531
Start Date
June 1 2018
End Date
May 5 2023
Last Update
June 7 2023
Active Locations (1)
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1
Sinai Centrum
Amstelveen, North Holland, Netherlands, 1180EB