Program for Alleviating and Resolving Trauma and Stress 1

NCT04713501 | Completed

• 1 other identifier: CHA-IRB-1158/09/20
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

PTSD; stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Retention

  Week 16

• Acceptability as assessed by Satisfaction Survey

  Week 16

• Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks

  Week 16

• Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks

  Week 16

• Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks

  Week 16

Other Outcomes (8)

• Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks

  Week 16

• Change from Baseline Pictorial Representation of Illness and Self Measure (PRISM) --Trauma at 16 Weeks

  Week 16

• Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks

  Week 16

Study Arms (1)

PARTS

EXPERIMENTAL

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

Interventions

PARTS Program BEHAVIORAL

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.

PARTS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Foundation for Self Leadership: collaborator

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

Location

Related Publications (12)

• 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.

  PMID: 30178492 BACKGROUND

• 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.

  PMID: 28493729 BACKGROUND

• 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.

  PMID: 26606250 BACKGROUND

• Eisen SV, Schultz MR, Ni P, Haley SM, Smith EG, Spiro A, Osei-Bonsu PE, Nordberg S, Jette AM. Development and Validation of a Computerized-Adaptive Test for PTSD (P-CAT). Psychiatr Serv. 2016 Oct 1;67(10):1116-1123. doi: 10.1176/appi.ps.201500382. Epub 2016 Jun 1.

  PMID: 27247175 BACKGROUND

• 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.

  PMID: 22278709 BACKGROUND

• 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.

  PMID: 16281216 BACKGROUND

• 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.

  PMID: 26030317 BACKGROUND

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 BACKGROUND

• 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.

  PMID: 18449942 BACKGROUND

• Lau MA, Bishop SR, Segal ZV, Buis T, Anderson ND, Carlson L, Shapiro S, Carmody J, Abbey S, Devins G. The Toronto Mindfulness Scale: development and validation. J Clin Psychol. 2006 Dec;62(12):1445-67. doi: 10.1002/jclp.20326.

  PMID: 17019673 BACKGROUND

• Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

  PMID: 30513087 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: December 22, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)