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临床试验/NCT04587518
NCT04587518进行中(未招募)不适用

Five Factor Model Treatment for Borderline Personality Disorder

Shannon E. Sauer-Zavala2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Change in clinician-rated borderline personality disorder symptoms

研究概览

简要总结

The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year), and have, understandably, focused on targeting the life-threatening and therapy-interrupting behaviors that often characterize this disorder. BPD, however, is a heterogeneous disorder with diagnostic criteria that can be combined to create over 300 unique symptom presentations (Ellis, Abrams, & Abrams, 2008); to date, no treatments have been explicitly designed with lower risk presentations of BPD in mind. This is unfortunate, as there is evidence to suggest that the majority of individuals with BPD do not demonstrate the recurrent life-threatening behaviors that warrant intensive, long-term care (Trull, Useda, Conforti, & Doan, 1997; Zimmerman & Coryell, 1989). Additionally, various studies have shown that the difficulties experienced by individuals with BPD can be understood as manifestations of maladaptive variants of personality traits (e.g., Mullins-Sweatt et al., 2012). Specifically, individuals with BPD demonstrate high levels of neuroticism, and low levels of agreeableness (antagonism) and conscientiousness (disinhibition); these traits may not be universally present across all individuals with BPD, perhaps underscoring the heterogeneity in presentations of this condition.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of borderline personality disorder (BPD)

排除标准

  • diagnosed psychological conditions that would be better addressed by alternative treatments
  • previously received more than 5 sessions of cognitive behavioral therapy in the past 5 years
  • concurrent psychotherapy
  • medication instability

研究组 & 干预措施

Immediate Treatment

Experimental

Participants in this group will receive the intervention immediately.

干预措施: Personality-Based Cognitive Behavioral Therapy (Behavioral)

Waitlist/Delayed Treatment

Experimental

Participants in this group will receive the intervention after an 18-week wait.

干预措施: Personality-Based Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Change in clinician-rated borderline personality disorder symptoms

时间窗: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)

Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - clinician-rated version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms

Change in clinician-rated clinical severity

时间窗: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)

Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity.

Change in Anxiety Symptoms

时间窗: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)

Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.

Change in patient-reported borderline personality disorder symptoms

时间窗: 18 weeks (week 1[baseline for immediate treatment condition, post-waitlist for delayed treatment condition], week, 2, week 3, week, 4.....week 18)

Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - self-report version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms

Change in Depressive Symptoms

时间窗: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)

Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.

次要结局

未报告次要终点

研究者

发起方
Shannon E. Sauer-Zavala
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shannon E. Sauer-Zavala

Assistant Professor

University of Kentucky

研究点 (2)

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