跳至主要内容
临床试验/NCT02574429
NCT02574429已完成不适用

Pilot Study Examining the Impact of a Cognitive Processing Therapy (CPT) Group for Patients With Co-Occurring Borderline Personality Disorder and Posttraumatic Stress Disorder

St. Joseph's Healthcare Hamilton3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
3
主要终点
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

研究概览

简要总结

Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.

详细描述

Borderline personality disorder (BPD) is a severe psychological disorder characterized by instability in emotion regulation, interpersonal relationships, and self-image, coupled with marked impulsivity. Additionally, individuals with BPD often meet criteria for other disorders. One of the most commonly co-occurring disorders among individuals diagnosed with BPD is posttraumatic stress disorder (PTSD). Within this population, 56% to 58% of inpatients, and between 36% to 50% of outpatients are diagnosed with co-occurring PTSD.

The high prevalence of this co-occurrence is consistent with studies documenting the severe traumatic experiences (including, but not limited to, physical, sexual, and emotional abuse, both as children and adults) commonly experienced by individuals diagnosed with BPD . Additionally, risk factors for PTSD identified by meta-analyses share striking commonalities with those of BPD, including: lack of social support, prior history of trauma (including childhood abuse), and poor psychological adjustment prior to trauma.

The co-occurrence of BPD/PTSD is associated with poorer outcomes and significant distress than the presence of either disorder alone. For example, individuals with co-occurring BPD/PTSD exhibit a lower likelihood of remission from BPD after 10 years of follow-up, and are also more likely to engage in non-suicidal self-injurious behavior (NSSI). In addition, BPD patients diagnosed with PTSD are also faced with greater emotional dysfunction and global psychological distress, as well as inferior physical health compared to individuals with BPD alone.

Several studies have proposed theories on the high co-occurrence of these disorders, but few have investigated potential treatments to address the unique issues associated with this comorbidity. The current standard of treatment for BPD, Dialectical Behaviour Therapy (DBT), has a solid empirical basis, including numerous randomized control trials (RCTs) demonstrating its efficacy in the reduction of associated symptoms. Despite the efficacy of DBT, the DBT treatment manual (Linehan, 1993) did not outline a specific protocol for intervention in patients with co-occurring BPD and PTSD. Moreover, outcomes from DBT trials indicate that DBT alone does not adequately treat co-occurring BPD/PTSD. Specifically, data from an RCT evaluating DBT in suicidal women with BPD demonstrated that only 13% of patients diagnosed with BPD/PTSD achieved full remission from PTSD during one year of DBT.

Recently, researchers have focused on identifying how to treat individuals with BPD and PTSD within the context of DBT. Harned and colleagues have developed and tested a combined DBT PE protocol that has shown efficacy in treating BPD/PTSD. This combined treatment addresses some of the problems inherent in the direct application of the conventional PTSD treatment, prolonged exposure (PE) therapy for individuals with BPD. Evaluations of PE show that PE significantly reduces PTSD symptoms and secondary outcomes such as depression. PE is designed to counteract avoidance of traumatic memories through repeated exposure to the traumatic memory, as well as in vivo exposure to non-dangerous events perceived to be fearful by the patient. The intention of the treatment is to alleviate overestimation of the likelihood and severity of negative outcomes, as well as conditioned fear responses to certain situations, often experienced by PTSD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed with co-occurring BPD/PTSD who are either currently participating in Standard Dialectical Behaviour Therapy (DBT) or who have completed DBT

排除标准

  • 未提供

研究组 & 干预措施

Cognitive Processing Therapy

Experimental

Individuals who have either completed Standard Dialectical Behavior Therapy (DBT) for Borderline Personality Disorder (BPD) and/or are currently enrolled in DBT who have co-occuring PTSD.

干预措施: Cognitive Processing Therapy (Behavioral)

结局指标

主要结局

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

时间窗: Weekly for 13 weeks (course of treatment)

Self-report measure assessing change in PTSD DSM-5 symptoms are affecting the participant. The investigators are comparing pre-PCL scores to post-PCL scores. In addition, the investigators are interested in examing the pattern of change between sessions.

次要结局

  • BSL-23(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Ways of Coping Checklist (WCCL)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Self-compassion Scale (SCS)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Depression, Anxiety, Stress and Suicide Scale (DASS-21)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Difficulties in Emotion Regulation Scale (DERS)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Experience of Shame Scale(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Anxiety Sensitivity Index (ASI-3)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • Borderline Evaluation of Severity Overtime (BEST)(2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment)
  • The Life Events Checklist for DSM-5 (LEC-5)(Baseline only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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