Program for Alleviating and Resolving Trauma and Stress 1

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: PARTS Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Interventional Model Description: PARTS is a live-online group program intended to alleviate and resolve symptoms of stress and PTSD for patients in a community health care system.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PARTS<br>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. | Behavioral: PARTS Program<br>* 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.<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 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. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | A secondary aim is to evaluate feasibility by demonstrating at least 50% of participants are retained in the program at 16 weeks.. | Week 16 | 
| Acceptability as assessed by Satisfaction Survey | Participants will complete a satisfaction survey and rate their likeliness to recommend the program to a friend, on a five point Likert-type scale. An average greater than 3 out of 5 represents acceptability. | Week 16 | 
| 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 | 

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