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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMcMaster University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trauma-Informed Goal Management Training (TIGMT)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Trauma Informed Goal Management Training (TIGMT)Active comparator 1 intervention
Group B: Trauma Informed Goal Management Training - Assist (TIGMT-Assist)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in symptom severity as assessed by the International Trauma Interview (ITI) at post-intervention.

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.

Time frame
"Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)

Secondary outcomes

1

Demographic Information - Age

Age, collected numerically in years (e.g., 29 years old).

Time frame
Collected at "Baseline" only (Week 0)
2

Demographic Information - Sex

Collected qualitatively from a list of options, including "other not listed above" with an open-text field.

Time frame
Collected at "Baseline" only (Week 0)
3

Demographic Information - Education

Collected qualitatively from a list of options, including "other not listed above" with an open-text field.

Time frame
Collected at "Baseline" only (Week 0)
4

Demographic Information - Relationship Status

Collected qualitatively from a list of options, including "other not listed above" with an open-text field.

Time frame
Collected at "Baseline" only (Week 0)

Other outcomes

Sponsors and contacts

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