Program for Alleviating and Resolving Trauma and Stress 1 (PARTS1)

October 5, 2021 updated by: Zev Schuman Olivier, Cambridge Health Alliance

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

To qualify for inclusion in this study, a prospective participant must:

  1. Be 18-70 years of age for the duration of the study;
  2. Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
  3. Be a current patient of CHA primary care, behavioral health care or CHA MindWell;
  4. Have a current diagnosis of PTSD OR a CAT-MH PTSD measure P-CAT>58;
  5. Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
  6. Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups;
  7. Must be available and willing to attend the scheduled online group sessions for 16 weeks; and
  8. 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:

  1. 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);
  2. Current participation in another experimental research study;
  3. Expected medical hospitalization in the next six months from enrollment period;
  4. Expected incarceration in the next six months from enrollment period;
  5. Individuals who are pregnant with a due date within 26 weeks after study consent;
  6. 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;

  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: PARTS Program
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks
Time Frame: Week 16
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 Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks
Time Frame: Week 16
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
Retention
Time Frame: Week 16
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
Time Frame: Week 16
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 (CAT-PTSD) at 16 Weeks
Time Frame: Week 16
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16
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 Depression (CAT-DI) at 16 Weeks
Time Frame: Week 16
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 will assess depression severity with the CAT-DI.
Week 16
Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks
Time Frame: Week 16
The PSS-4 uses 4 items to measure the degree to which situations in life are stressful, evaluating how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5-point Likert scale from 0 (Never) to 4 (Very often).
Week 16
Change from Baseline Multidimensional Assessment of Interoceptive Awareness (MAIA-2) at 16 Weeks
Time Frame: Week 16
The MAIA-2 is a 37-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness (e.g., body trusting).
Week 16
Change from Baseline Pictorial Representation of Illness and Self Measure (PRISM) --Trauma at 16 Weeks
Time Frame: Week 16
The Pictorial Representation of Illness and Self Measure (PRISM) is a visual method to assess the global burden of illness, measuring the participant's "self-trauma fusion". Using the iPrism Lite ipad app, the user places a disk representing the illness in relation to a disk representing the self.
Week 16
Change from Baseline Toronto Mindfulness Scale (TMS) at 16 Weeks
Time Frame: Week 16
The TMS is a 13-item scale evaluating mindfulness factors of curiosity and decentering.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

Foundation for Self Leadership

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-1158/09/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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