Program for Alleviating and Resolving Trauma and Stress 2

NCT05095428 | Completed

• 1 other identifier: CHA-IRB-21-22-18
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot RCT will test the preliminary efficacy of an intensive group model of Internal Family Systems (IFS) called the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) attention placebo control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, the effects of the interventions on self-reported PTSD symptoms, disassociation, and disturbances of self-organization (DSO), as well as mechanisms of emotion regulation, decentering and self-compassion will be secondary outcomes.

Conditions

Post-traumatic Stress Disorder

Keywords

PTSD; stress; RCT

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 16 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 (7)

• 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

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

  Week 16

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

  Week 16

Other Outcomes (9)

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

  Week 16

• Change from Baseline Depression (CAT-DI) at 16 Weeks

  Week 16

• Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks

  Week 16

Study Arms (2)

PARTS

EXPERIMENTAL

The Program for Alleviating and Resolving Trauma and Stress (PARTS) Program is a 16-week group intervention model of Internal Family Systems (IFS), with 8 individual IFS clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.

Behavioral: PARTS Program

NBSR-T

ACTIVE COMPARATOR

The Nature Based Stress Reduction for Trauma Survivors (NBSR-T) Program is a 16-week nature-based group intervention model, with 8 individual non-IFS clinical sessions on a biweekly basis, developed as an attention placebo control for individuals diagnosed with PTSD.

Behavioral: NBSR-T Program

Interventions

PARTS Program BEHAVIORAL

The PARTS Program is a 16-week group intervention model of Internal Family Systems (IFS), with 8 individual IFS clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.

PARTS

NBSR-T Program BEHAVIORAL

The NBSR-T Program is a 16-week nature-based group intervention model, with 8 individual non-IFS clinical sessions on a biweekly basis, developed as an attention placebo control for individuals diagnosed with PTSD.

NBSR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to bill insurance for 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 score \>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:

• 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 any other reason);
• Current participation in another experimental research study;
• Expected medical hospitalization in six months from the date of enrollment;
• Expected incarceration in six months from the date of enrollment;
• Individuals who are pregnant with a due date within 26 weeks after study consent;
• Insufficient level of severity of PTSD symptoms: CAPS-5 SEV2 Total score less than 26; PTSD score of less than 31 on the PTSD Checklist for DSM-V (PCL-5)8 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 \> 30 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-MH5 (\>70)
• Acute suicidality or self-injurious behavior
• Severe depression, indicated by CAT-DI \> 755,65
• 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. In addition, use of or positive toxicology for illicit drugs (e.g., cocaine, opioids, etc.) or non-prescribed controlled medications (i.e., opioids, stimulants, or benzodiazepines) in the past 3 months.

Sponsors & Collaborators

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

Study Sites (1)

Cambridge Health Alliance Center for Mindfulness and Compassion

Somerville, Massachusetts, 02143, United States

Location

Related Publications (13)

• 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

• 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

• 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

• Kok T, De Haan HA, Sensky T, van der Meer M, De Jong CAJ. Using the Pictorial Representation of Illness and Self Measure (PRISM) to Quantify and Compare Suffering From Trauma and Addiction. J Dual Diagn. 2017 Apr-Jun;13(2):101-108. doi: 10.1080/15504263.2017.1293867. Epub 2017 Feb 22.

  PMID: 28368709 BACKGROUND

• Buchi S, Villiger P, Kauer Y, Klaghofer R, Sensky T, Stoll T. PRISM (Pictorial Representation of Illness and Self Measure)- a novel visual method to assess the global burden of illness in patients with systemic lupus erythematosus. Lupus. 2000;9(5):368-73. doi: 10.1191/096120300678828479.

  PMID: 10878730 BACKGROUND

• Joss D, Comeau A, Chevannes R, Parry G, Rea HS, Barria J, Bumpus C, Rector A, Rajan A, Rosansky J, Rice FK, Ward MC, Tobiasz Veltz L, Ally D, Rosenberg LG, Sweezy M, Lovas D, Schuman-Olivier Z. A randomized controlled trial of an online group-based internal family systems treatment for posttraumatic stress disorder: The Program for Alleviating and Resolving Trauma and Stress (PARTS) study. Psychol Trauma. 2026 Jan 29. doi: 10.1037/tra0002089. Online ahead of print.

  PMID: 41609644 DERIVED

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, M.D.

  Center for Mindfulness and Compassion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware of study hypotheses or arms and will be told the study is for stress reduction among people with trauma/PTSD. The staff member responsible for final determination of study eligibility will be blinded to the randomization sequence. The Data Analyst and methodologist will be blinded to participant identity prior to and during randomization and analysis. The PI will be blinded to participant randomization status for the duration of the study. Medical Review Officer: The MRO will not be blinded and will be responsible for advising on adverse events. Independent Evaluators conducting the CAPS-5 assessments will be blinded to the participants' randomization status. To protect this, independent CAPS-5 evaluators will be located separately from group leaders and therapists. In the event of an unintentional unblinding, a new rater will be assigned to assess the relevant participant(s).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Mindfulness and Compassion and Director of Addiction Research

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 27, 2021
• Study Start: April 28, 2022
• Primary Completion: September 12, 2023
• Study Completion: November 8, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)