borderline personality disorder (BPD) and cluster C personality disorder (CPD) post-traumatic stress disorder (PTSD)
Conditions
Interventions
In patients with PTSD and BPD: EMDR (6 months plus 6 months treatment pause)
compared to integrated DBT-EMDR-treatment (12 months)
in patients with PTSD and CPD: ImRs (6 months plus 6 months treatment pause)
compared to integrated ImRs-SFT treatment (12 months).
Sponsors
Arkin (Amsterdam)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is PTSD symptom response rate after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are PTSD symptom effect size and PD symptom effect size and response rate after 12 months. At baseline (T0) and after 6 (T2) and 12 months (T4) clinical interviews (CAPS-5, SCID-II dimensional score) and self-rating scales (PCL-5) will be used. After 3 months (T1) and 9 months (T3), and at follow-up (18 months), questionnaires only will be used. Other outcome measures are quality of life and health costs. At baseline, candidate predictors and mediators will be measured including cognitive (educational level/IQ, working memory, emotion regulation), affective (anger, sleep, dissociation), relational factors (therapeutic alliance, attachment, social support) and hormonal en epi-genetic factors (cortisol/FKBP-5 methylation, oxytocin/OXTR-gene, serotonin/ 5HTTLPR-gene). In a subgroup, hair cortisol, BDNF and FKBP-5 will be measured again. In a second subgroup, structural and functional MR, with resting-state, face recognition and Stop task will be performed. | — |
Countries
Netherlands
Outcome results
None listed