Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT06354361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD)
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
A Randomized Control Trial Examining the Efficacy of a Novel, Trauma-informed Approach to Cognitive Remediation (Goal Management Training) in Public Safety Personnel With Post-traumatic Stress Disorder (PTSD) and Co-morbid Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD).
The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.
The main questions it aims to answer are:
1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?
2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?
3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?
Participants will:
* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* participate in a nine-week group treatment program (one day a week for two hours)
* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.
The main questions it aims to answer are:
1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?
2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?
3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?
Participants will:
* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* participate in a nine-week group treatment program (one day a week for two hours)
* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: