PROSPER - Prediction and Outcome Study in PTSD and Personality disorders

• Conditions: borderline personality disorder (BPD) and cluster C personality disorder (CPD); post-traumatic stress disorder (PTSD); 10034726

• Registration Number: NL-OMON50353
• Lead Sponsor: Arkin (Amsterdam)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 292

Inclusion Criteria

See Page 22 of the research protocol:
In order to be eligible for study participation, a subject must meet all of
following criteria at T0:
- Diagnosed with PTSD (309.81)
- Diagnosed with a personality disorder (301.81 borderline, 301.4
obsessive-compulsive, 301.6 dependent, 301.82 avoidant), or at least 4 PD
symptoms of those PDs (301.9 PD otherwise specified).
- Age between 18 and 65 years
- Written informed consent is obtained
- Speak / understand Dutch sufficiently

Exclusion Criteria

See page 22 of the research protocol:
A patient who meets any of following criteria will be excluded from
participation in this study:
- 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
For the subgroup that also undergo MRI examination more exclusion criteria are:
- Pregnancy
- Metal implants (such as pacemakers, etc.)
- Somatic disorders interfering with brain functioning
- Claustrophobia
- High dosis benzodiazepines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is PTSD symptom response rate after 12 months.</p><br>