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

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ClinicalTrials.gov Identifier: NCT04713501
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
Foundation for Self Leadership
Information provided by (Responsible Party):
Cambridge Health Alliance

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Behavioral: PARTS Program Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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..

  2. 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.

  3. 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.

  4. 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

  5. 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.


Other Outcome Measures:
  1. 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").

  2. 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.

  3. 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.)

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713501


Contacts
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Contact: Alexandra Comeau, BA 617-806-8735 acomeau@challiance.org
Contact: Lydia Smith 781-850-6592 lysmith@challiance.org

Locations
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United States, Massachusetts
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02141
Contact: Alexandra Comeau, BA    617-806-8735    acomeau@challiance.org   
Principal Investigator: Zev Schuman-Olivier, MD         
Sponsors and Collaborators
Cambridge Health Alliance
Foundation for Self Leadership
Investigators
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Principal Investigator: Zev Schuman-Olivier, MD Cambridge Health Alliance
Publications:
Gratz, K.L., Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26, 41-54 (2004). https://doi.org/10.1023/B:JOBA.0000007455.08539.94

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Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT04713501    
Other Study ID Numbers: CHA-IRB-1158/09/20
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cambridge Health Alliance:
PTSD; stress
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders