A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
研究概览
简要总结
Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.
Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Must reside in the Bay Area, CA
- •Current DSM-5 diagnosis of PTSD and BPD
- •Must be willing to be audio- or videorecorded for assessment and treatment sessions
排除标准
- •Acute mania, acute psychosis, or intellectual disability
- •Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
- •Severe impairments in written and aural comprehension
- •EU individuals
结局指标
主要结局
Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
时间窗: Baseline, once a week while in treatment (for 6 weeks)
A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.
次要结局
- Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Beck's Depression Inventory-II (BDI-II) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- PTSD Checklist-5 (PCL-5) [SELF-REPORT](Baseline, once a week while in treatment (for 6 weeks))
- Acceptability of Intervention Measure (AIM)(Baseline and Post-treatment/6-weeks)
- Patient Health Questionnaire - 9 (PHQ-9)(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Suicide Attempt Self-Injury Interview (SASII)(3-weeks, Post-treatment/6-weeks, 3-month follow-up)
- Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- State-Trait Anxiety Inventory, Trait Version (STAI-T)(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Suicidal Behaviors Questionnaire-Revised(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Substance Use Inventory (SUI)(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Rate of dropout(Pre-post treatment (6 weeks))
- Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)(Baseline, 3-weeks, Post-treatment/6-weeks)
- The International Personality Disorder Exam (IPDE, BPD only)(Baseline)
- The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)(Baseline)
- A Demographic Form [SELF-REPORT](Baseline)
- Generalized Anxiety Disorder - 7 (GAD7)(Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT](Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up)
- Treatment sessions attended(Pre-post treatment (6 weeks))
- Emotional Reactivity and Attentional Biases via Oddball task(Baseline, Post-treatment/6-weeks, 3-months follow-up)
- Mental Health Involvement Scale [SELF-REPORT](Post-treatment/6-weeks)
- Measure of CPT+SRM Uptake [SELF-REPORT](9-months after concluding treatment with the last study participant)
- The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)(Baseline)
研究者
Janice Kuo
Professor
Palo Alto University