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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change from baseline in symptom severity as assessed by the International Trauma Interview (ITI) at post-intervention. — "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
  The International Trauma Interview (ITI) is a structured, clinician-administered diagnostic interview used to assess trauma exposure and to make current diagnoses of ICD-11 Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). The interview evaluates the three core ICD-11 PTSD symptom clusters (re-experiencing, avoidance, and sense of current threat), as well as disturbances in self-organization (affective dysregulation, negative self-concept, and relational disturbances), and associated functional impairment. Diagnostic determinations are based on symptom presence, duration, trauma linkage, and functional impact.

Trial sites (1)

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