Viewing Study NCT05095428



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Last Modification Date: 2024-10-26 @ 2:16 PM
Study NCT ID: NCT05095428
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-04-02
First Post: 2021-10-05

Brief Title: Program for Alleviating and Resolving Trauma and Stress 2
Sponsor: Cambridge Health Alliance
Organization: Cambridge Health Alliance

Study Overview

Official Title: 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: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PARTS2
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
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None