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

NCT07797543 | Not Yet Recruiting

• 1 other identifier: 19577
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress

Keywords

Goal Management Training; Trauma Informed Goal Management Training

Outcome Measures

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.

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

Secondary Outcomes (25)

• Demographic Information - Age

  Collected at "Baseline" only (Week 0)

• Demographic Information - Sex

  Collected at "Baseline" only (Week 0)

• Demographic Information - Education

  Collected at "Baseline" only (Week 0)

• Demographic Information - Relationship Status

  Collected at "Baseline" only (Week 0)

• Demographic Information - Employment Status

  Collected at "Baseline" only (Week 0)

Study Arms (2)

Trauma Informed Goal Management Training (TIGMT)

ACTIVE COMPARATOR

All participants will be assigned to the TIGMT condition and will be asked to attend nine weekly, 2-hour virtual group sessions of TIGMT via Zoom for Healthcare, a PHIPA-compliant video conferencing platform. Each group will consist of 1 or 2 facilitators and up to 10 participants.

Behavioral: Trauma-Informed Goal Management Training (TIGMT)

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

EXPERIMENTAL

All participants will be assigned to the TIGMT-Assist condition and will be asked to attend nine weekly, 2-hour virtual group sessions of TIGMT and an additional three psychoeducational "Support-Person Module" sessions attended jointly by the Primary Participant (the individual experiencing post-traumatic stress) and their Support Participant (a trusted family member, partner, or friend), via Zoom for Healthcare, a PHIPA-compliant video conferencing platform. Each group will consist of 1 or 2 facilitators and up to 10 participants.

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

Interventions

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 (TIGMT)

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L9C 1G2, Canada

Location

Related Publications (3)

• Protopopescu A, O'Connor C, Cameron D, Boyd JE, Lanius RA, McKinnon MC. A Pilot Randomized Controlled Trial of Goal Management Training in Canadian Military Members, Veterans, and Public Safety Personnel Experiencing Post-Traumatic Stress Symptoms. Brain Sci. 2022 Mar 12;12(3):377. doi: 10.3390/brainsci12030377.

  PMID: 35326333 BACKGROUND

• Boyd JE, Sanger BD, Cameron DH, Protopopescu A, McCabe RE, O'Connor C, Lanius RA, McKinnon MC. A Pilot Study Assessing the Effects of Goal Management Training on Cognitive Functions among Individuals with Major Depressive Disorder and the Effect of Post-Traumatic Symptoms on Response to Intervention. Brain Sci. 2022 Jun 30;12(7):864. doi: 10.3390/brainsci12070864.

  PMID: 35884671 BACKGROUND

• Boyd JE, O'Connor C, Protopopescu A, Jetly R, Rhind SG, Lanius RA, McKinnon MC. An Open-Label Feasibility Trial Examining the Effectiveness of a Cognitive Training Program, Goal Management Training, in Individuals With Posttraumatic Stress Disorder. Chronic Stress (Thousand Oaks). 2019 Apr 18;3:2470547019841599. doi: 10.1177/2470547019841599. eCollection 2019 Jan-Dec.

  PMID: 32440592 BACKGROUND

Study Officials

• Margaret McKinnon, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Co-Lead

CONTACT

6476369963; brignalk@mcmaster.ca

Christina Chrysler, BA (Hons)

CONTACT

chrysl@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CA (1)