Clinical Trials Directory

Trials / Completed

CompletedNCT05095428

Program for Alleviating and Resolving Trauma and Stress 2

The PARTS Study: A Pilot Randomized Controlled Trial of the PARTS Intensive IFS Program vs. a Nature-based Stress Reduction Program for PTSD in a Community Mental Health Clinic

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
82 (actual)
Sponsor
Cambridge Health Alliance · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

The investigators will conduct a pilot RCT to test the preliminary efficacy of the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). 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

Interventions

TypeNameDescription
BEHAVIORALPARTS ProgramThe 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.
BEHAVIORALNBSR-T ProgramThe 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.

Timeline

Start date
2022-04-28
Primary completion
2023-09-12
Completion
2023-11-08
First posted
2021-10-27
Last updated
2025-07-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05095428. Inclusion in this directory is not an endorsement.