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

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PARTS Program
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD; stress

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cambridge Health Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PARTS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Retention
A secondary aim is to evaluate feasibility by demonstrating at least 50% of participants are retained in the program at 16 weeks..
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.
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.
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
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.

Full Information

First Posted
January 12, 2021
Last Updated
October 5, 2021
Sponsor
Cambridge Health Alliance
Collaborators
Foundation for Self Leadership
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1. Study Identification

Unique Protocol Identification Number
NCT04713501
Brief Title
Program for Alleviating and Resolving Trauma and Stress 1
Acronym
PARTS1
Official Title
Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Foundation for Self Leadership

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
PTSD; stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PARTS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PARTS Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline CAPS-5 at 16 Weeks
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Retention
Description
A secondary aim is to evaluate feasibility by demonstrating at least 50% of participants are retained in the program at 16 weeks..
Time Frame
Week 16
Title
Acceptability as assessed by Satisfaction Survey
Description
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.
Time Frame
Week 16
Title
Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks
Description
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.
Time Frame
Week 16
Title
Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks
Description
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
Time Frame
Week 16
Title
Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks
Description
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.
Time Frame
Week 16
Other Pre-specified Outcome Measures:
Title
Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks
Description
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").
Time Frame
Week 16
Title
Change from Baseline Pictorial Representation of Illness and Self Measure (PRISM) --Trauma at 16 Weeks
Description
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.
Time Frame
Week 16
Title
Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks
Description
The MDI is a 30-item self-report inventory measuring frequency of dissociative symptoms (e.g., depersonalization, derealization, emotional constriction, identity dissociation, etc.)
Time Frame
Week 16
Title
Change from Baseline Depression (CAT-DI) at 16 Weeks
Description
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.
Time Frame
Week 16
Title
Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks
Description
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.
Time Frame
Week 16
Title
Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks
Description
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).
Time Frame
Week 16
Title
Change from Baseline Toronto Mindfulness Scale (TMS) at 16 Weeks
Description
The TMS is a 13-item scale evaluating mindfulness factors of curiosity and decentering.
Time Frame
Week 16
Title
Change from Baseline Multidimensional Assessment of Interoceptive Awareness (MAIA-2) at 16 Weeks
Description
The MAIA-2 is a 37-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness (e.g., body trusting).
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zev Schuman-Olivier, MD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30178492
Citation
Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
Results Reference
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Citation
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
Results Reference
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PubMed Identifier
26606250
Citation
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
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Citation
Wittmann L, Schnyder U, Buchi S. PRISM (Pictorial Representation of Illness and Self Measure): a new method for the assessment of suffering after trauma. J Trauma Stress. 2012 Feb;25(1):94-7. doi: 10.1002/jts.20710. Epub 2012 Jan 25.
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PubMed Identifier
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Citation
Briere J, Weathers FW, Runtz M. Is dissociation a multidimensional construct? Data from the Multiscale Dissociation Inventory. J Trauma Stress. 2005 Jun;18(3):221-31. doi: 10.1002/jts.20024.
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Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.
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Citation
Mitchell AM, Crane PA, Kim Y. Perceived stress in survivors of suicide: psychometric properties of the Perceived Stress Scale. Res Nurs Health. 2008 Dec;31(6):576-85. doi: 10.1002/nur.20284.
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Program for Alleviating and Resolving Trauma and Stress 1

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