Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713501
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2021-01-12
Brief Title:
Program for Alleviating and Resolving Trauma and Stress 1
Sponsor:
Cambridge Health Alliance
Organization:
Cambridge Health Alliance
Study Overview
Official Title:
Program for Alleviating and Resolving Trauma and Stress Study Stage 1 Pilot
Status:
COMPLETED
Status Verified Date:
2021-10
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:
PARTS1
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 CredibilityExpectancy 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
Secondary outcomes include feasibility and acceptability of the PARTS program measured by a CredibilityExpectancy 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
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