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NCT07797543

Trauma Informed Goal Management Training With a "Support Person" Module for Individuals Impacted by Post-Traumatic Stress

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether adding a Support-Person Module to Trauma-Informed Goal Management Training (TIGMT) can improve engagement and recovery among individuals who have experienced traumatic events and are currently experiencing post-traumatic stress. Post-Traumatic Stress Disorder (PTSD) and symptoms of trauma-related stress can occur following traumatic events such as physical, sexual, or emotional abuse, car accidents, or working in public safety roles. Individuals experiencing post-traumatic stress may feel overwhelmed by memories of traumatic events, avoid trauma reminders, remain on high alert for danger, and experience difficulties managing emotions. Cognitive difficulties, including problems with memory, attention, and planning, are also common and can interfere with everyday functioning. There has been limited research examining how best to address these cognitive challenges. This study will compare two versions of a program designed to improve daily functioning and reduce trauma-related distress by strengthening cognitive skills. Trauma-Informed Goal Management Training (TIGMT) is a 9-week, trauma-informed adaptation of Goal Management Training (GMT). GMT is designed to improve cognitive skills, including attention, multitasking, mental flexibility, planning, and problem-solving, as well as the ability to achieve goals in everyday life. TIGMT adapts GMT by incorporating education about trauma-related symptoms and their effects on cognitive functioning, as well as mindfulness and strategies targeting emotional regulation. Trauma-Informed Goal Management Training-Assist (TIGMT-Assist) builds on TIGMT by adding a Support-Person Module. Each participant selects a trusted adult, such as a family member, partner, or friend, to serve as a support person. Participants complete the full 9-week TIGMT program and attend three additional Support-Person Module sessions with their selected support person. Support persons attend only these three additional sessions. The sessions are designed to increase understanding of the program and provide strategies for reinforcing skills learned during TIGMT. By comparing TIGMT with TIGMT-Assist, the study aims to determine whether involving a support person improves program engagement, retention and use of learned skills, cognitive functioning, trauma-related symptoms, and quality of life. Findings may help inform future approaches to trauma-informed cognitive training for individuals experiencing post-traumatic stress.

Official title: A Pilot Study Examining the Addition of a "Support Person" Module to Enhance a Trauma-Informed Cognitive Remediation Program (TIGMT) for Individuals Impacted by Post-Traumatic Stress (TIGMT-Assist)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2027-03

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Post Traumatic Stress

Interventions

BEHAVIORAL

Trauma-Informed Goal Management Training (TIGMT)

TIGMT closely follows the structure and topics of the standard GMT program (GMT was developed by Dr. Brian Levine and his team at Baycrest Hospital in Toronto, ON and has proven to be an effective program for cognitive remediation in several populations), with several trauma-informed adaptations. These include psychoeducational material on trauma-related concepts and PTSD symptoms, dissociation, the "window of tolerance" and changes in arousal, and the effects of these on cognitive functioning. It also includes modifications that increase relevance and tolerability for individuals with trauma exposure through the adjustment of examples within the intervention to include trauma-associated changes in cognition, and present-mindedness exercises that may be better tolerated by individuals with trauma exposure.

BEHAVIORAL

Trauma Informed Goal Management Training - Assist (TIGMT-Assist)

TIGMT-ASSIST is an enhanced version of the standard TIGMT program. It retains the core nine-session, trauma-informed, cognitive remediation program and introduces an additional Support-Person Module consisting of three psychoeducational sessions attended jointly by the Primary Participant (the individual experiencing post-traumatic stress) and their Support Participant (a trusted family member, partner, or friend). The purpose of TIGMT-Assist is to evaluate whether integrating a social support psychoeducation component enhances engagement, retention, and the generalization of cognitive and self-regulatory skills learned during TIGMT.

Inclusion Criteria: * be able to read, write, and speak English fluently * reside in Ontario * be able to provide written informed consent * be between the ages of 18 and 65 (to ensure generalizable results) * meet screening criteria for PTSD or Complex-PTSD (CPTSD) on the ITQ, administered at the time of screening, to be corroborated with the results of the ITI * be able to attend regular online, 2-hour sessions once/week for 9 weeks, and be willing to complete the pre-, post-intervention, and follow-up assessments * have reliable access to a computer with a working microphone and camera, and * have reliable and consistent access to the internet. Exclusion Criteria: * use benzodiazepines daily or almost daily * use narcotics daily or almost daily * meet criteria for Alcohol/Cannabis use that may interfere with their ability to participate in the study, as assessed by the AUDIT and CUDIT-R embedded into the eligibility pre-screener and corroborated with the DART (to be determined by the clinical team) * have a history of Moderate to Severe brain injury or loss of consciousness with prolonged effects that interfere with daily functioning at school, work, or within the family unit * have a history of a neurological disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team) * have a diagnosis of psychotic disorder, borderline personality disorder, or bipolar disorder * have a diagnosis of a neurodevelopmental disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team) * have other conditions/impairments/considerations that could interfere with completion of study tasks or participation in the study (to be determined by Dr. McKinnon's clinical team) * have previously participated in GMT * are receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants * have had ECT within the past year * are currently engaged in a trauma-focused intervention that may confound the findings of the current study (to be determined by Dr. McKinnon's clinical team) * are an active serving member of the Canadian Armed Forces.

Locations (1)

McMaster University

Hamilton, Ontario, Canada