Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207409
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-09-07
Brief Title:
Program for Alleviating and Reducing Trauma Stress and Substance Use
Sponsor:
Cambridge Health Alliance
Organization:
Cambridge Health Alliance
Study Overview
Official Title:
Program for Alleviating and Reducing Trauma Stress and Substance Use PARTS-SUD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
PARTS-SUD
Brief Summary:
This single-arm study will test the preliminary efficacy of a virtually delivered live-online 12-week group model of Internal Family Systems IFS for individuals with posttraumatic stress disorder PTSD and substance use disorders Program for Alleviating and Reducing Trauma Stress and Substance Use PARTS-SUD
Participants will be in a group for 12 weeks and will be asked to complete survey sessions at baseline and during week 4 8 and 12
Participants will be in a group for 12 weeks and will be asked to complete survey sessions at baseline and during week 4 8 and 12
Detailed Description:
The investigators have conducted a single arm study of a 16 week PARTS group-based program for PTSD symptoms which demonstrated large effect reductions on PTSD symptoms disturbances in self-organization DSO disassociation emotion dysregulation suicide risk anxiety depression and increases in decentering and self-compassion A randomized control trial RCT of PARTS groups vs a control is currently underway and will complete by September 2023 This will be a single-arm feasibility and acceptability pilot study of PARTS for PTSD among patients with substance use disorders
While 16 weeks is the typical length for PTSD intervention trials the average treatment length for PTSD-SUD population studies is only 12 weeks given higher risk of attrition with longer treatments for substance use disorder SUD Clinically the group is anticipated to have the most impact on symptoms between weeks and 12 based on the curriculum and practices during those sessions so the investigators will pilot a 12 week group in this study Similar to past PARTS studies participants will also have every other week 50 minute individual counseling sessions Since IFS and group psychotherapy are established modalities and the pilot trial for PARTS established its evidence as a program with a clinically meaningful effect this feasibility and acceptability study will primarily focus on the engagement and acceptability of the intervention among patients with PTSD-SUD Both group and individual sessions will be billed to insurance as per standard Cambridge Health Alliance CHA outpatient clinical protocols To reduce burden from past studies the investigators will not conduct Clinician-Administered PTSD Scale CAPS-5 interviews but solely use self-report measures PTSD Checklist For DSM-5 PCL-5 and Computerized Adaptive Testing for PTSD CAT-PTSD which have a high level of correlation with CAPS-5
The investigators aim to have 10-12 participants allocated to start the program aiming for 70 of completion of the study intervention defined as 75 completion of sessions and 70 completion of week 12 assessments with adequate intervention acceptability After participants have completed all baseline screenings assessments and the informed consent procedure a study staff member will contact them to begin the virtual program delivered in real time over the secure HIPAA compliant video conference eg Google Meets Zoom
Surveys Procedures and Duration The duration of the study period is 12 weeks see Figure 1 Participants will complete screening surveys and a long survey battery at baseline survey batteries approximately 62 minutes at study Week 4 8 and 12 and weekly substance use and craving self-report assessments
All study procedures screening consent and assessments can be conducted virtually by videoconference and online through the secure REDCap survey database These procedures may also be conducted in-person at a CHA community mental health center andor at the Center for Mindfulness and Compassion CMC 350 Commerce Place Malden MA
While 16 weeks is the typical length for PTSD intervention trials the average treatment length for PTSD-SUD population studies is only 12 weeks given higher risk of attrition with longer treatments for substance use disorder SUD Clinically the group is anticipated to have the most impact on symptoms between weeks and 12 based on the curriculum and practices during those sessions so the investigators will pilot a 12 week group in this study Similar to past PARTS studies participants will also have every other week 50 minute individual counseling sessions Since IFS and group psychotherapy are established modalities and the pilot trial for PARTS established its evidence as a program with a clinically meaningful effect this feasibility and acceptability study will primarily focus on the engagement and acceptability of the intervention among patients with PTSD-SUD Both group and individual sessions will be billed to insurance as per standard Cambridge Health Alliance CHA outpatient clinical protocols To reduce burden from past studies the investigators will not conduct Clinician-Administered PTSD Scale CAPS-5 interviews but solely use self-report measures PTSD Checklist For DSM-5 PCL-5 and Computerized Adaptive Testing for PTSD CAT-PTSD which have a high level of correlation with CAPS-5
The investigators aim to have 10-12 participants allocated to start the program aiming for 70 of completion of the study intervention defined as 75 completion of sessions and 70 completion of week 12 assessments with adequate intervention acceptability After participants have completed all baseline screenings assessments and the informed consent procedure a study staff member will contact them to begin the virtual program delivered in real time over the secure HIPAA compliant video conference eg Google Meets Zoom
Surveys Procedures and Duration The duration of the study period is 12 weeks see Figure 1 Participants will complete screening surveys and a long survey battery at baseline survey batteries approximately 62 minutes at study Week 4 8 and 12 and weekly substance use and craving self-report assessments
All study procedures screening consent and assessments can be conducted virtually by videoconference and online through the secure REDCap survey database These procedures may also be conducted in-person at a CHA community mental health center andor at the Center for Mindfulness and Compassion CMC 350 Commerce Place Malden MA
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