Program for Alleviating and Resolving Trauma and Stress 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: PARTS Program
* Behavioral: NBSR-T Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PARTS<br>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. | Behavioral: PARTS Program<br>* The 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.<br>|
| Active Comparator: NBSR-T<br>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. | Behavioral: NBSR-T Program<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline CAPS-5 at 16 Weeks | 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. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks | Participants will be sent a link to complete the PTSD Checklist for DSM-5 (PCL-5), which is a self-report measure with 20 items, which is designed to measure PTSD symptom severity over the past month as measured by the DSM-5, in combination with additional diagnostic tools. | Week 16 | 
| Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks | Participants will be sent a link to complete the CAT-MH (Computer Adaptive Testing for Mental Health) interview on a computer, tablet or phone. This outcome refers to the CAT-PTSD severity score. | Week 16 | 
| Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks | The International Trauma Questionnaire (ITQ) is the first instrument designed to capture the ICD-11 PTSD and Complex PTSD (CPTSD) diagnoses. The last 6 items measure DSO symptoms characteristic of ICD-11 CPTSD. Each set of items have 3 severity of impact on functioning questions. The ITQ-DSO-9 includes just the 6 DSO items with 3 severity questions. The ITQ-DSO-9 will be used monthly for self-report of changes in DSO symptoms. | Week 16 | 
| Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks | The DERS is a 36-item self-report scale designed to assess emotional dysregulation. The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses (When I'm upset, I become embarrassed for feeling that way), difficulties engaging in goal directed behavior (When I'm upset, I have difficulty thinking about anything else), impulse control difficulties (When I'm upset, I lose control over my behaviors), lack of emotional awareness (When I'm upset, I take time to figure out what I'm really feeling (reverse-scored), limited access to emotion regulation strategies (When I'm upset, it takes me a long time to feel better), and lack of emotional clarity (I have no idea how I am feeling). | Week 16 | 
| Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks | The MDI is a 30-item self-report inventory measuring frequency of dissociative symptoms (e.g., depersonalization, derealization, emotional constriction, identity dissociation, etc.) | Week 16 | 
| Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks | The SCS-SF is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. This scale evaluates 6 different aspects of self-compassion: Self-Kindness (e.g., ''I try to be understanding and patient toward those aspects of my personality I don't like''), Self-Judgment (e.g., ''I'm disapproving and judgmental about my own flaws and inadequacies''), Common Humanity (e.g., ''I try to see my failings as part of the human condition''), Isolation (e.g., ''When I feel inadequate in some way, I try to remind myself that feelings of inadequacy are shared by most people), Mindfulness (e.g., ''When something painful happens I try to take a balanced view of the situation''), and Over-Identification (e.g., ''When I'm feeling down I tend to obsess and fixate on everything that's wrong.''). The scale is scored on a 5-point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored. | Week 16 | 
| Change from Baseline Decentering (EQ-D) at 16 weeks | The EQ-D is an 11-item scale representing the Decentering items of the Experiences Questionnaire. | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, PTSD, stress