Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296589
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
Sponsor:
Veterans Medical Research Foundation
Organization:
Veterans Medical Research Foundation
Study Overview
Official Title:
Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure TrIGR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
PORT
Brief Summary:
The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction TrIGR Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt The main questions it aims to answer are
Will TrIGR be comparable to PE in terms of PTSD symptom reduction Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms Will it be superior in improving trauma-related guilt and shame
Will TrIGR be comparable to PE in terms of PTSD symptom reduction Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms Will it be superior in improving trauma-related guilt and shame
Detailed Description:
Trauma-related guilt is common and impairing among trauma survivors Guilt is positively associated with severity of PTSD and depression symptoms poorer psychosocial functioning and suicide risk Although existing evidence-based trauma-focused PTSD treatments such as Prolonged Exposure PE are effective in treating PTSD and trauma-related guilt many still experience symptoms or maintain their diagnosis after treatment Preliminary research shows that a brief treatment targeting trauma-related and moral injury-related guilt and shame Trauma Informed Guilt Reduction Therapy TrIGR can reduce guilt PTSD depression and distress among Veterans and help them reengage with meaningful activities Whether TrIGR is comparably effective to longer more resource heavy evidence-based PTSD treatments disseminated across DoD and VA like PE is a critical question
The proposed randomized clinical trial aims to determine if TrIGR is non-inferior to a first tier PTSD treatment PE Hypotheses are that 6 sessions of TrIGR will be non-inferior to 12 sessions of PE in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt Secondary aims are to evaluate the hypotheses that TrIGR will be non-inferiority relative to PE in improving psychosocial functioning and depression symptoms and superior in reducing trauma-related guilt and shame The study will also explore treatment differences in change in suicidal ideation and dropout
Participants will be recruited from mental health clinics across three VAs 158 Veterans who served since 911 and with PTSD and guilt from any type of trauma will be included TrIGR will be administered over 6 weekly sessions 60-minutes each and PE will be administered over 12 weekly sessions 90 minutes each Blind assessors will evaluate participants at baseline and 8- 16- and 28 weeks after the first therapy session Inclusion and exclusion criteria are minimized so that generalizability will be high
The proposed randomized clinical trial aims to determine if TrIGR is non-inferior to a first tier PTSD treatment PE Hypotheses are that 6 sessions of TrIGR will be non-inferior to 12 sessions of PE in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt Secondary aims are to evaluate the hypotheses that TrIGR will be non-inferiority relative to PE in improving psychosocial functioning and depression symptoms and superior in reducing trauma-related guilt and shame The study will also explore treatment differences in change in suicidal ideation and dropout
Participants will be recruited from mental health clinics across three VAs 158 Veterans who served since 911 and with PTSD and guilt from any type of trauma will be included TrIGR will be administered over 6 weekly sessions 60-minutes each and PE will be administered over 12 weekly sessions 90 minutes each Blind assessors will evaluate participants at baseline and 8- 16- and 28 weeks after the first therapy session Inclusion and exclusion criteria are minimized so that generalizability will be high
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