Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from Baseline CAPS-5 at 16 Weeks
研究概览
简要总结
This single-arm pilot study (Phase 1) will test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, feasibility, acceptability, and effects on self-report PTSD and disturbances of self-organization (DSO) will be secondary outcomes.
详细描述
The investigators will conduct a single-arm pilot study to test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5).
Secondary outcomes include feasibility and acceptability of the PARTS program measured by a Credibility/Expectancy Questionnaire (CEQ) and Treatment Satisfaction Questionnaire. Secondary clinical outcomes include the effects of the PARTS program on self-report PTSD and disturbances of self-organization (DSO). Exploratory aims of the study are to investigate the effects on emotion regulation (DERS), self-trauma fusion (iPRISM-trauma), disassociation (MDI), depression (CAT-DI), self-compassion (SCS-SF), perceived stress (PSS), mindfulness (TMS), and interception (MAIA-2). Additional exploratory outcomes include changes in outcome variables among PTSD subjects with baseline DSO and those without DSO as defined by the International Trauma Questionnaire (ITQ).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To qualify for inclusion in this study, a prospective participant must:
- •Be 18-70 years of age for the duration of the study;
- •Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
- •Be a current patient of CHA primary care, behavioral health care or CHA MindWell;
- •Have a current diagnosis of PTSD OR a CAT-MH PTSD measure P-CAT>58;
- •Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
- •Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups;
- •Must be available and willing to attend the scheduled online group sessions for 16 weeks; and
- •Must be available and willing to complete the online computerized assessments and phone interviews.
排除标准
- •Any and all of the following criteria will exclude a prospective participant from the study:
- •Inability to complete an informed consent assessment AND/OR inability to complete baseline study assessment procedures (due to cognitive deficit, non- proficiency in English literacy, or for any other reason);
- •Current participation in another experimental research study;
- •Expected medical hospitalization in the next six months from enrollment period;
- •Expected incarceration in the next six months from enrollment period;
- •Individuals who are pregnant with a due date within 26 weeks after study consent;
- •Insufficient level of severity of PTSD symptoms: PTSD score of less than 33 on the PTSD Checklist for DSM-V (PCL-5) at screening visit;
- •Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
- •Past year history of a psychotic disorder or clinician confirmed active psychosis (Severe level of psychosis on PSY-S-CAT > 60 will trigger the requirement of a clinical assessment prior to participation in the program)
- •Bipolar I disorder history or severe level of mania on CAT-M/HM (>70)
- •Acute suicidality or self-injurious behavior
- •Severe depression, indicated by CAT-DI PHQ-9 equivalency score >20
- •Acute homicidality with plan and/or intent;
- •Hospitalization for suicide attempt or self-harm within three months of the enrollment period;
- •Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
- •Moderate or severe Substance Use Disorder.
研究组 & 干预措施
PARTS
The PARTS Program is a 16-week group intervention model, with 8 individual clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.
干预措施: PARTS Program (Behavioral)
结局指标
主要结局
Change from Baseline CAPS-5 at 16 Weeks
时间窗: Week 16
The primary aim of this study is to examine the preliminary efficacy of a live-online version of the PARTS program on PTSD symptoms measured by reduction in CAPS-5 over 24 weeks. The CAPS-5 is a 30-item questionnaire administered by a trained interviewer and is considered the "gold standard" assessment for PTSD diagnosis and symptoms as defined by the DSM-5. This measure also assesses the duration of symptoms, impact of symptoms on aspects of the participant's life, and if the participant meets criteria for the dissociative subtype of PTSD.
次要结局
- Acceptability as assessed by Satisfaction Survey(Week 16)
- Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks(Week 16)
- Retention(Week 16)
- Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks(Week 16)
- Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks(Week 16)
研究者
Zev Schuman Olivier
Assistant Professor, Psychiatry
Cambridge Health Alliance