Clinical trial NCT04713501: Program for Alleviating and Resolving Trauma and Stress 1
Official title: Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: PTSD; stress
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Foundation for Self Leadership
First posted: 2021-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Change from Baseline CAPS-5 at 16 Weeks
timeFrame: Week 16
Secondary outcomes:
measure: Retention
timeFrame: Week 16
measure: Acceptability as assessed by Satisfaction Survey
timeFrame: Week 16
measure: Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks
timeFrame: Week 16
Other outcomes:
measure: Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Pictorial Representation of Illness and Self Measure (PRISM) --Trauma at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Depression (CAT-DI) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Toronto Mindfulness Scale (TMS) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Multidimensional Assessment of Interoceptive Awareness (MAIA-2) at 16 Weeks
timeFrame: Week 16
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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