STAIR for Trauma and Emotion Dysregulation
2022年5月25日 更新者:Sanno Zack、Stanford University
Examining the Effectiveness of STAIR as an Alternative to DBT for Patients With Emotion Dysregulation and PTSD
This study will examine the impact of Skills Training in Affective and Interpersonal Regulation (STAIR) group, using self-report measures, on Posttraumatic Stress Disorder (PTSD), emotional dysregulation, borderline personality disorder symptoms, global psychopathology, and access to quality mental health care.
Aims include assessing the feasibility of STAIR, reducing patients' trauma and emotion dysregulation symptoms, examining whether STAIR may be used as an alternative to DBT for patients on the DBT, and improving patient satisfaction and clinic efficiency
研究概览
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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Stanford、California、美国、94305
- Stanford University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Be 18 years or older.
- Have a DSM-5 diagnosis and/or symptoms for which DBT is an indicated treatment
- Meet DSM-5 criteria for a diagnosis of posttraumatic stress disorder (PTSD)
- Meet criteria at a subclinical level for BPD (a minimum of three symptoms)
- Must be able to make group commitments for attendance, safety, and sobriety during group
Exclusion Criteria:
- If currently receiving individual therapy that follows the DBT protocol or is an evidence-based trauma-focused therapy
- If the STAIR therapy group is determined to be clinically contraindicated
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:STAIR
Participants will complete 1.5 hr group sessions once per week for 12 weeks of Skills Training in Affective and Interpersonal Regulation (STAIR).
Participants will complete self-report measures pre, post, and at one month intervals.
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Clinician led session that hones in on a particular deficit within these skills, including identifying and labeling emotions, managing emotions, tolerating distress, accepting feelings and increasing positive emotions, identifying trauma-based interpersonal schemas, identifying conflict between trauma-related feelings and goals, role plays surrounding issues of power and control, and role-plays related to developing flexibility in interpersonal situations involving power differentials.
STAIR is a cognitive-behavioral treatment that addresses emotion regulation and interpersonal difficulties and their impact on daily living.
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实验性的:Waitlist control
First, participants will remain on the DBT waitlist for 12 weeks receiving no active intervention and will complete pre and post-measures.
Then participants will complete 1.5 hr group sessions once per week for 12 weeks of Skills Training in Affective and Interpersonal Regulation (STAIR).
Participants will complete self-report measures pre, post, and at one month intervals.
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Clinician led session that hones in on a particular deficit within these skills, including identifying and labeling emotions, managing emotions, tolerating distress, accepting feelings and increasing positive emotions, identifying trauma-based interpersonal schemas, identifying conflict between trauma-related feelings and goals, role plays surrounding issues of power and control, and role-plays related to developing flexibility in interpersonal situations involving power differentials.
STAIR is a cognitive-behavioral treatment that addresses emotion regulation and interpersonal difficulties and their impact on daily living.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants who complete the STAIR intervention
大体时间:Week 12
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This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions
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Week 12
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Total score of patient treatment satisfaction ratings
大体时间:Week 12
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Calculate the total score for each participant on the Client Satisfaction Questionnaire-8, and find the average of those scores.
Scores are summed across items.
Items 2, 4, 5, and 8 are reverse scored.
Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
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Week 12
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Frequency of participant attendance
大体时间:Week 1 through Week 12
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Calculate the number of patients who attended each week of the STAIR treatment.
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Week 1 through Week 12
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Change in emotion regulation total score from baseline to Week 12
大体时间:Baseline to Week 12
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Problems with emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale.
Total score ranges from 36 to 180.
Higher scores indicate greater problems with emotion regulation.
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Baseline to Week 12
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Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12
大体时间:Baseline to Week 12
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The severity of posttraumatic stress disorder symptoms is measured using the PCL-5.
Items are rated using a 5-point likert scale ranging from 0 "not at all" to 4 "extremely."
All 20 items are summed to obtain a total score (0 to 80), higher scores indicate higher severity of PTSD symptoms.
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Baseline to Week 12
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Change in Borderline symptom severity total score from baseline to Week 12
大体时间:Baseline and Week 12
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Using the Borderline Evaluation of Severity Scale comprising of 15 items using a likert scale rated from 5 "Almost Always" to 1 "Almost Never."
There are three subscales that comprise this measure: (1) Thoughts and Emotions (2) Behaviors-Negative and (3) Behaviors-Positive.
The total for each subscale is determined to score the BEST.
The scores of subscales A and B are then added together and the total from subscale C is subtracted.
A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
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Baseline and Week 12
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Change in Borderline Symptom List-23 total score from baseline to Week 12
大体时间:Baseline and Week 12
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This measure assesses feelings and experiences commonly endorsed by patients with BPD.
The 23-item scale utilizes a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very strong."
The BSL-23 is scored by summing up the scores for all of the items.
Total score ranges from 0 to 92, with higher scores reflecting more severe borderline personality symptoms.
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Baseline and Week 12
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Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12
大体时间:Baseline and Week 12
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The Symptom Checklist-90-Revised is a 90-item multidimensional self-report symptom measure that assesses current symptoms of psychopathology and psychological distress.
The items were scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).
It assesses nine symptom dimensions (somatization, obsessive compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism).
Global measures are provided to summarize overall distress, and these include the Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total.
Raw scores are calculated by dividing the sum of scores for a specific dimension by the number of items in the dimension.
Global severity index is calculated by summing the scores of the nine dimensions and additional items, then dividing by the total number of responses.
Total score ranges from 0 to 360.
Higher scores indicate worsening of disease.
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Baseline and Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sanno Zack, PhD、Stanford Universtiy
- 首席研究员:Emily Livermore, PsyD、Stanford University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年6月15日
初级完成 (预期的)
2025年6月15日
研究完成 (预期的)
2025年6月15日
研究注册日期
首次提交
2022年5月24日
首先提交符合 QC 标准的
2022年5月25日
首次发布 (实际的)
2022年5月31日
研究记录更新
最后更新发布 (实际的)
2022年5月31日
上次提交的符合 QC 标准的更新
2022年5月25日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
边缘性人格障碍的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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Dren BioNovotech招聘中侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 系统性 EBV1 T 细胞淋巴瘤,如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤,鼻型 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)(CD8+ 或 NK 衍生) | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤美国, 澳大利亚, 法国, 西班牙
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Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阳性 | 结外 NK/T 细胞淋巴瘤,鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国
STAIR的临床试验
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Boston Medical CenterNational Institute of Mental Health (NIMH)完全的
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New York UniversityUniversity of California, Davis; Cohen Veterans Network尚未招聘沮丧 | 创伤后应激障碍 | 亲子关系
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Palo Alto Veterans Institute for ResearchHarvard Medical School (HMS and HSDM); National Institute of Mental Health (NIMH); Georgetown... 和其他合作者完全的
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NYU Langone HealthNational Institute on Drug Abuse (NIDA)尚未招聘