Prediction and Outcome Study in PTSD and (Cluster C) Personality Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- CAPS-5 (Clinician Administered PTSD Scale)
研究概览
简要总结
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).
详细描述
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 CPD, ImRs-only will be compared to integrated SFT-ImRs (PROSPER-C).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessments will be performed by allocation-blind assessors. Upon seeing a participant for an assessment, assessors are instructed to immediately state that participants are not allowed to discuss aspects of the treatment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
CAPS-5 (Clinician Administered PTSD Scale)
时间窗: 12 months
The CAPS-5 is a structured diagnostic interview to assess the frequency and severity of DSM-5 PTSD symptoms. The interview consists of 30 items, with higher scores indicating more severe symptomatology. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. To meet the criteria for PTSD diagnoses, at least one Criterion B and one Criterion C symptom, and two criterion D and E symptoms are required. Furthermore, Criterion F and G should be met.
次要结局
- SCID-5-S (Structured Clinical Interview for DSM-5 Disorders - syndrome disorders)(12 months)
- EQ-5D-5L (EuroQOL - 5 Dimensions - 5 Levels)(12 months)
- Tic-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness)(12 months)
- WHODAS 2.0 (World Health Organization Disability Assessment Schedule)(12 months)
- SMI-118 (Schema Mode Inventory - 118 Items)(12 months)
- OQ-45 (Outcome Questionnaire-45)(12 months)
- AUDIT (Alcohol Use Disorders Identification Test)(12 months)
- NSSI (Non-Suicidal Self-Injury)(12 months)
- PAI-BOR (Personality Assessment Inventory- Borderline features scale)(12 months)
- SCID-5-PD (Structured Interview for DSM-5 Personality Disorders)(12 months)
- PCL-5 (PTSD Checklist for DSM-5)(12 months)
- BDI (Beck depression inventory)(12 months)
- YSQ-75 (Young Schema Questionnaire - 75 Items)(12 months)