The PARTS Study: A Pilot Randomized Controlled Trial of the PARTS Intensive IFS Program vs. a Nature-based Stress Reduction Program for PTSD in a Community Mental Health Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 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 pilot RCT will test the preliminary efficacy of an intensive group model of Internal Family Systems (IFS) called the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) attention placebo control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, the effects of the interventions on self-reported PTSD symptoms, disassociation, and disturbances of self-organization (DSO), as well as mechanisms of emotion regulation, decentering and self-compassion will be secondary outcomes.
详细描述
The investigators will conduct a pilot RCT to test the preliminary efficacy of the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5).
Secondary clinical outcomes include the effects of the intervention on self-reported PTSD symptoms (PCL-5; CAT-PTSD), disassociation (MDI), and disturbances of self-organization (ITQ). Secondary mechanistic outcomes include emotion regulation (DERS), self-compassion (SCS-SF), and decentering (EQ-D) .
Exploratory aims of the study are to investigate the effects on depression (CAT-DI), mental health (CAT-MH scales), self-trauma fusion (PRISM-D), perceived stress (PSS), internalized stigma (ISMI), and interoception (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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be unaware of study hypotheses or arms and will be told the study is for stress reduction among people with trauma/PTSD.
The staff member responsible for final determination of study eligibility will be blinded to the randomization sequence.
The Data Analyst and methodologist will be blinded to participant identity prior to and during randomization and analysis.
The PI will be blinded to participant randomization status for the duration of the study.
Medical Review Officer: The MRO will not be blinded and will be responsible for advising on adverse events.
Independent Evaluators conducting the CAPS-5 assessments will be blinded to the participants' randomization status. To protect this, independent CAPS-5 evaluators will be located separately from group leaders and therapists. In the event of an unintentional unblinding, a new rater will be assigned to assess the relevant participant(s).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to bill insurance for 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 score >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
- •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 any other reason);
- •Current participation in another experimental research study;
- •Expected medical hospitalization in six months from the date of enrollment;
- •Expected incarceration in six months from the date of enrollment;
- •Individuals who are pregnant with a due date within 26 weeks after study consent;
- •Insufficient level of severity of PTSD symptoms: CAPS-5 SEV2 Total score less than 26; PTSD score of less than 31 on the PTSD Checklist for DSM-V (PCL-5)8 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 > 30 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-MH5 (>70)
- •Acute suicidality or self-injurious behavior
- •Severe depression, indicated by CAT-DI > 755,65
- •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. In addition, use of or positive toxicology for illicit drugs (e.g., cocaine, opioids, etc.) or non-prescribed controlled medications (i.e., opioids, stimulants, or benzodiazepines) in the past 3 months.
研究组 & 干预措施
PARTS
The Program for Alleviating and Resolving Trauma and Stress (PARTS) Program is a 16-week group intervention model of Internal Family Systems (IFS), with 8 individual IFS 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)
NBSR-T
The Nature Based Stress Reduction for Trauma Survivors (NBSR-T) Program is a 16-week nature-based group intervention model, with 8 individual non-IFS clinical sessions on a biweekly basis, developed as an attention placebo control for individuals diagnosed with PTSD.
干预措施: NBSR-T 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 16 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
- 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)
- Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks(Week 16)
- Change from Baseline Decentering (EQ-D) at 16 weeks(Week 16)
- Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks(Week 16)
- Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks(Week 16)
- Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks(Week 16)
研究者
Zev Schuman Olivier
Director, Center for Mindfulness and Compassion and Director of Addiction Research
Cambridge Health Alliance