Program for Alleviating and Resolving Trauma and Stress 2
NCT ID: NCT05095428
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
82 participants
INTERVENTIONAL
2022-04-28
2023-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Program for Alleviating and Resolving Trauma and Stress 1
NCT04713501
Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy
NCT05155930
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
NCT04937504
Brief Integrative Therapy for Post-Traumatic Stress Disorder
NCT00047684
Stepped Care for Posttraumatic Stress Disorder Study
NCT06947538
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary clinical outcomes include the effects of the intervention on self-reported PTSD symptoms (PCL-5; CAT-PTSD), disassociation (MDI), and disturbances of self-organization (ITQ). Secondary mechanistic outcomes include emotion regulation (DERS), self-compassion (SCS-SF), and decentering (EQ-D) .
Exploratory aims of the study are to investigate the effects on depression (CAT-DI), mental health (CAT-MH scales), self-trauma fusion (PRISM-D), perceived stress (PSS), internalized stigma (ISMI), and interoception (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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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).
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PARTS
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.
PARTS Program
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.
NBSR-T
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.
NBSR-T Program
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PARTS Program
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.
NBSR-T Program
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foundation for Self Leadership
OTHER
Cambridge Health Alliance
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zev Schuman Olivier
Director, Center for Mindfulness and Compassion and Director of Addiction Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zev Schuman-Olivier, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Mindfulness and Compassion
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cambridge Health Alliance Center for Mindfulness and Compassion
Somerville, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHA-IRB-21-22-18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.