Post Traumatic StressTIGMT-AssistNCT07797543
Trauma Informed Goal Management Training With a "Support Person" Module for Individuals Impacted by Post-Traumatic Stress
A study testing Trauma-Informed Goal Management Training (TIGMT) and Trauma Informed Goal Management Training - Assist (TIGMT-Assist) in people with Post Traumatic Stress, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress
- What is being tested?
- Trauma-Informed Goal Management Training (TIGMT) and Trauma Informed Goal Management Training - Assist (TIGMT-Assist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christina Chrysler, BA (Hons) contact
Canada1 site
McMaster University
Hamilton, Ontario, L9C 1G2
Clinical Research Co-Lead, 6476369963, brignalk@mcmaster.ca
Clinical Research Co-Lead, 9055177852, chrysl@mcmaster.ca
About this study
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)
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.
Read the detailed description
This pilot study uses a two-arm, non-randomized controlled design to evaluate the feasibility, acceptability, and preliminary efficacy of Trauma-Informed Goal Management Training-Assist (TIGMT-Assist) compared with Trauma-Informed Goal Management Training (TIGMT). TIGMT-Assist was developed to examine whether structured involvement of a trusted support person can enhance engagement with trauma-informed cognitive remediation and facilitate the application and retention of cognitive and self-regulatory strategies in everyday life. TIGMT is a trauma-informed adaptation of Goal Management Training (GMT), a manualized cognitive remediation intervention targeting executive control and goal-directed behaviour. TIGMT retains the core GMT framework while incorporating psychoeducation regarding post-traumatic stress, dissociation, changes in arousal and the "window of tolerance," and the effects of trauma-related symptoms on cognitive functioning. Trauma-informed modifications are also incorporated into intervention examples and present-mindedness exercises to increase their relevance and tolerability for individuals affected by trauma. The intervention incorporates interactive cognitive tasks, mindfulness practice, homework, group discussion, and strategies targeting present-mindedness, working memory, goal setting, decision-making, and management of complex tasks. The TIGMT-Assist condition retains the nine core TIGMT sessions and adds a three-session Support-Person Module. Primary participants identify a trusted adult, such as a family member, partner, or friend, to participate as a support person. Support persons participate in the Support-Person Module but do not attend the nine core cognitive remediation sessions. The module is intended to provide support persons with a framework for understanding post-traumatic stress and associated cognitive and functional difficulties, while increasing familiarity with the principles and strategies taught during TIGMT so that these strategies can be reinforced outside of the TIGMT intervention sessions. The Support-Person Module consists of two introductory psychoeducational sessions and one consolidation session. The first two sessions introduce post-traumatic stress and its clinical features, the effects of trauma on cognition and executive functioning, emotion regulation, interpersonal relationships and functioning, and the goals and strategies of TIGMT. The final session consolidates learning related to post-traumatic stress, social functioning, cognitive impacts, social support, and the application of TIGMT strategies to daily life. The second half of the final session includes a focus-group discussion with primary participants and their support persons regarding their experiences with the intervention. Participants are assigned to TIGMT or TIGMT-Assist based on availability for scheduled group sessions and whether a support person is available and willing to participate. Due to the nature of the interventions, participants and facilitators cannot be blinded to study condition. Research staff conducting assessments and data analysis are blinded to treatment condition. The study includes baseline and post-intervention assessment periods. Post-intervention assessments occur immediately following completion of the 9-week TIGMT condition or 12-week TIGMT-Assist condition. Quantitative assessment is designed to characterize change in clinical symptoms, cognitive functioning, executive functioning, disability, and related functional domains. Intervention adherence is also tracked through session attendance, homework completion, and participant dropout. As a pilot study, a central focus is determining the feasibility and acceptability of adding structured support-person involvement to TIGMT. Feasibility is evaluated through factors including recruitment, retention, treatment adherence, attendance, homework completion, and intervention tolerability. Feedback from primary participants and support persons is used to identify perceived benefits, barriers to participation, and opportunities to refine the Support-Person Module. The study also examines whether TIGMT-Assist shows preliminary evidence of improving treatment engagement, adherence, skill retention, cognitive functioning, trauma-related symptoms, and real-world functioning relative to TIGMT alone. Quantitative analyses will follow intention-to-treat principles. Linear mixed-effects models will include fixed effects for treatment condition, time, and the condition-by-time interaction, with random intercepts for participants to account for repeated measurements. Planned contrasts will examine between-group differences and within-group change, with adjustment for multiple comparisons. Missing-data patterns will be evaluated, with multiple imputation used under Missing at Random assumptions where appropriate and sensitivity analyses comparing complete-case and imputed datasets. Secondary analyses will explore whether changes in self-reported cognitive functioning mediate treatment effects on clinical outcomes. Qualitative information collected through participant feedback and the TIGMT-Assist focus group will complement quantitative findings by examining participants' subjective experiences of the intervention and support-person involvement. Focus-group data will be examined using an inductive thematic analysis approach based on Braun and Clarke's six-step framework. Multiple coders will contribute to initial coding and development of the coding framework, with themes reviewed at semantic and latent levels and refined to represent relevant content across transcripts. Together, the pilot study is designed to establish whether incorporating structured support-person psychoeducation into trauma-informed cognitive remediation is feasible and acceptable and to generate preliminary evidence regarding whether this approach may enhance engagement, generalization of learned strategies, and cognitive and psychosocial recovery.
- Conditions
- Post Traumatic Stress
- Being tested
- Trauma-Informed Goal Management Training (TIGMT), Trauma Informed Goal Management Training - Assist (TIGMT-Assist)
- Keywords
- Goal Management Training, Trauma Informed Goal Management Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Goal Management Training (TIGMT)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Trauma Informed Goal Management Training - Assist (TIGMT-Assist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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
Age, collected numerically in years (e.g., 29 years old).
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Sex
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Education
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Relationship Status
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Employment Status
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Socioeconomic Status
Collected qualitatively from a list of options (income ranges).
Measured: Collected at "Baseline" only (Week 0)
Demographic Information - Profession
Collected qualitatively, with an open-text field.
Measured: Collected at "Baseline" only (Week 0)
Scores on the International Trauma Exposure Measure (ITEM) Assessing Past Trauma Exposure
The International Trauma Exposure Measure (ITEM) is a brief self-report measure designed to assess lifetime exposure to potentially traumatic events in accordance with ICD-11 definitions. The ITEM captures exposure across a range of trauma types, including single-incident, repeated, and prolonged interpersonal and non-interpersonal events, and is used to identify qualifying trauma exposure and index events for subsequent trauma-related assessment. The ITEM has 21 dichotomously scored trauma exposure items (Yes = 1, No = 0), yielding a total lifetime trauma exposure score ranging from 0 to 21, with higher scores indicating exposure to a greater number of traumatic events.
Measured: Administered at "Baseline" only (Week 0)
Change from baseline in score on the International Trauma Questionnaire (ITQ) at post-intervention
The International Trauma Questionnaire (ITQ) is an 18-item self-report measure designed to assess symptoms of ICD-11 Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). The ITQ evaluates the three core PTSD symptom clusters (re-experiencing, avoidance, and sense of current threat), disturbances in self-organization (affective dysregulation, negative self-concept, and disturbances in relationships), and associated functional impairment. Symptom items are rated on a 5-point Likert scale (0 = Not at all to 4 = Extremely). PTSD and disturbances in self-organization (DSO) symptom subscale scores each range from 0 to 24, and the total symptom score ranges from 0 to 48, with higher scores indicating greater PTSD/CPTSD symptom severity.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in mental health diagnoses on the Diagnostic Research Assessment Tool (DART) at post-intervention
The Diagnostic Research Assessment Tool (DART) is a structured clinician-administered diagnostic interview used to assess psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnostic modules administered include Major Depressive Disorder, Persistent Depressive Disorder, Suicide Risk Assessment (if suicidal ideation is endorsed), Social Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Attack Specifier and Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Alcohol Use Disorder, Substance Use Disorder, and Depersonalization/Derealization Disorder. The DART is a diagnostic interview that yields categorical DSM-5 diagnoses rather than numerical scale scores; therefore, minimum and maximum scores are not applicable.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention
The Multiscale Dissociation Inventory (MDI) is a 30-item self-report measure that assesses six domains of dissociative symptoms experienced over the past month: disengagement, depersonalization, derealization, emotional constriction, memory disturbance, and identity dissociation. Items are rated on a 5-point Likert scale, and a total score ranging from 30 to 150 is calculated by summing item responses, with higher scores indicating greater dissociative symptom severity.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure that assesses difficulties in emotion regulation across six domains: nonacceptance of emotional responses, difficulties engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Items are rated on a 5-point Likert scale (1 = Almost Never to 5 = Almost Always). A total score ranging from 36 to 180 is calculated by summing item responses, with higher scores indicating greater difficulties in emotion regulation.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Moral Injury Outcome Scale ('MIOS-F') at post-intervention
The Moral Injury Outcome Scale - Full (MIOS-F) is a self-report measure designed to assess psychosocial outcomes associated with exposure to potentially morally injurious events (PMIEs). The measure includes an initial assessment of exposure to PMIEs, determination of whether the most distressing event meets DSM-5 Criterion A for trauma, and 14 items assessing moral injury-related outcomes over the past month. The 14 symptom items are rated on a 5-point Likert scale (0 = Strongly disagree to 4 = Strongly agree), yielding a total score ranging from 0 to 56, with higher scores indicating greater moral injury severity.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Scores on the Adverse Childhood Experiences International Questionnaire ('ACE-IQ') at baseline
The Adverse Childhood Experiences International Questionnaire (ACE-IQ) is a self-report measure that assesses exposure to a broad range of adverse childhood experiences (ACEs) across diverse cultural and international settings. It captures exposure to multiple categories of childhood adversity, including emotional, physical, and sexual abuse, neglect, household dysfunction, peer violence, community violence, and collective violence. Using the World Health Organization's standard scoring approach, responses are summarized into a cumulative ACE score ranging from 0 to 13, with higher scores indicating exposure to a greater number of categories of adverse childhood experiences.
Measured: Collected at "Baseline" only (Week 0)
Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention
The Cognitive Failures Questionnaire 2.0 (CFQ 2.0) is a 15-item self-report measure that assesses subjective experiences of cognitive failures in everyday life. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 60 is calculated by summing item responses, with higher scores indicating more frequent self-reported cognitive failures and greater perceived impairment in everyday cognitive functioning.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item self-report measure that assesses health and disability across six domains of functioning: cognition, mobility, self-care, getting along with others, life activities, and participation in society. Items are rated on a 5-point scale ranging from 0 (None) to 4 (Extreme or cannot do). Using the World Health Organization's scoring method (Score = (Retrieved Raw Score / Maximum Possible Raw Score) × 100) responses are converted to a total disability score ranging from 0 to 100, where 0 indicates no disability and 100 indicates complete disability. Higher scores indicate greater disability and functional impairment.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report measure that assesses the severity of symptoms of depression, anxiety, and stress experienced over the past week. Items are rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). Three subscale scores (Depression, Anxiety, and Stress) are calculated by summing responses to the seven items within each subscale. Raw scores are then multiplied by two-according to standard scoring procedures-such that the adjusted total scores range from 0 to 42. Higher scores indicate greater symptom severity, with established severity ranges used to classify symptoms as normal, mild, moderate, severe, or extremely severe.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the Executive Skills Questionnaire-Revised (ESQ-R) at post-intervention
The Executive Skills Questionnaire-Revised (ESQ-R) is a 25-item self-report measure that assesses executive functioning difficulties across five domains: plan management, time management, organization, emotional regulation, and behavioural regulation. Items are rated on a 4-point Likert scale ranging from 0 (Never or rarely) to 3 (Very often). A total score ranging from 0 to 75 is calculated by summing item responses, with higher scores indicating greater executive functioning difficulties.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the Multidimensional Scale of Perceived Social Support (MSPSS) at post-intervention
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report measure that assesses perceived social support from three sources: family, friends, and a significant other. Items are rated on a 7-point Likert scale ranging from 1 (Very strongly disagree) to 7 (Very strongly agree). A total score ranging from 12 to 84 is calculated by summing item responses, with higher scores indicating greater perceived social support.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Sustained Attention at post-intervention
The Rapid Visual Information Processing (RVP) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess sustained attention. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Attention and Visual Searching at post-intervention
Match to Sample Visual Search (MTS) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess attention and visual searching, with a speed-accuracy trade-off. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Executive Function, Planning, and Working Memory at post-intervention
One Touch Stockings of Cambridge (OTS) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess executive function, planning and working memory, measuring both latency and accuracy of responses. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Spatial Working Memory at post-intervention
Spatial Working Memory (SWM) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess retention and manipulation of visuospatial information, with notable executive function demands that measures strategy use and errors. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Spatial Planning at post-intervention
Stockings of Cambridge (SOC) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess spatial planning, requiring individuals to use problem-solving strategies to match two sets of stimuli in as few moves as possible. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Episodic Memory at post-intervention
Paired Associates Learning (PAL) subtest of the 'CANTAB' battery will be self-administered via 'CANTAB' (a web-based platform for assessing cognitive functioning) to assess visual memory, new learning, and episodic memory. A standard score (mean=100, SD=15) and corresponding percentile rank are derived from the individual's raw score to indicate where the individual's scores fall on a normal distribution. An individual with a standard score of 100 and corresponding percentile rank of 50 is exactly at the average score for these tasks, and scores above or below 100 can easily be understood in relation to this average. Higher scores may indicate greater performance on these tasks. Hypothetically, under the normal distribution, the 'minimum' and the 'maximum' values are unbounded, however, in practice, these values may range between ≤ 20 and ≥ 150.
Measured: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret McKinnon, McMaster University
- Investigators
- Margaret McKinnon, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797543
- Sponsor's protocol ID
- 19577
- Other IDs
- 19577
- Acronym
- TIGMT-Assist
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35326333Boyd 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.
PubMed 35884671Boyd 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.
PubMed 32440592
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07797543
- Acronym / sponsor ID
- TIGMT-Assist / 19577
- Conditions
- Post Traumatic Stress
- Keywords
- Goal Management Training, Trauma Informed Goal Management Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study uses a two-arm, non-randomized controlled design to evaluate the feasibility, acceptability, and preliminary efficacy of Trauma-Informed Goal Management Training-Assist (TIGMT-Assist) compared with Trauma-Informed Goal Management Training (TIGMT). TIGMT-Assist was developed to examine whether structured involvement of a trusted support person can enhance engagement with trauma-informed cognitive remediation and facilitate the application and retention of cognitive and self-regulatory strategies in everyday life. TIGMT is a trauma-informed adaptation of Goal Management Training (GMT), a manualized cognitive remediation intervention targeting executive control and goal-directed behaviour. TIGMT retains the core GMT framework while incorporating psychoeducation regarding post-traumatic stress, dissociation, changes in arousal and the "window of tolerance," and the effects of trauma-related symptoms on cognitive functioning. Trauma-informed modifications are also incorporated into intervention examples and present-mindedness exercises to increase their relevance and tolerability for individuals affected by trauma. The intervention incorporates interactive cognitive tasks, mindfulness practice, homework, group discussion, and strategies targeting present-mindedness, working memory, goal setting, decision-making, and management of complex tasks. The TIGMT-Assist condition retains the nine core TIGMT sessions and adds a three-session Support-Person Module. Primary participants identify a trusted adult, such as a family member, partner, or friend, to participate as a support person. Support persons participate in the Support-Person Module but do not attend the nine core cognitive remediation sessions. The module is intended to provide support persons with a framework for understanding post-traumatic stress and associated cognitive and functional difficulties, while increasing familiarity with the principles and strategies taught during TIGMT so that these strategies can be reinforced outside of the TIGMT intervention sessions. The Support-Person Module consists of two introductory psychoeducational sessions and one consolidation session. The first two sessions introduce post-traumatic stress and its clinical features, the effects of trauma on cognition and executive functioning, emotion regulation, interpersonal relationships and functioning, and the goals and strategies of TIGMT. The final session consolidates learning related to post-traumatic stress, social functioning, cognitive impacts, social support, and the application of TIGMT strategies to daily life. The second half of the final session includes a focus-group discussion with primary participants and their support persons regarding their experiences with the intervention. Participants are assigned to TIGMT or TIGMT-Assist based on availability for scheduled group sessions and whether a support person is available and willing to participate. Due to the nature of the interventions, participants and facilitators cannot be blinded to study condition. Research staff conducting assessments and data analysis are blinded to treatment condition. The study includes baseline and post-intervention assessment periods. Post-intervention assessments occur immediately following completion of the 9-week TIGMT condition or 12-week TIGMT-Assist condition. Quantitative assessment is designed to characterize change in clinical symptoms, cognitive functioning, executive functioning, disability, and related functional domains. Intervention adherence is also tracked through session attendance, homework completion, and participant dropout. As a pilot study, a central focus is determining the feasibility and acceptability of adding structured support-person involvement to TIGMT. Feasibility is evaluated through factors including recruitment, retention, treatment adherence, attendance, homework completion, and intervention tolerability. Feedback from primary participants and support persons is used to identify perceived benefits, barriers to participation, and opportunities to refine the Support-Person Module. The study also examines whether TIGMT-Assist shows preliminary evidence of improving treatment engagement, adherence, skill retention, cognitive functioning, trauma-related symptoms, and real-world functioning relative to TIGMT alone. Quantitative analyses will follow intention-to-treat principles. Linear mixed-effects models will include fixed effects for treatment condition, time, and the condition-by-time interaction, with random intercepts for participants to account for repeated measurements. Planned contrasts will examine between-group differences and within-group change, with adjustment for multiple comparisons. Missing-data patterns will be evaluated, with multiple imputation used under Missing at Random assumptions where appropriate and sensitivity analyses comparing complete-case and imputed datasets. Secondary analyses will explore whether changes in self-reported cognitive functioning mediate treatment effects on clinical outcomes. Qualitative information collected through participant feedback and the TIGMT-Assist focus group will complement quantitative findings by examining participants' subjective experiences of the intervention and support-person involvement. Focus-group data will be examined using an inductive thematic analysis approach based on Braun and Clarke's six-step framework. Multiple coders will contribute to initial coding and development of the coding framework, with themes reviewed at semantic and latent levels and refined to represent relevant content across transcripts. Together, the pilot study is designed to establish whether incorporating structured support-person psychoeducation into trauma-informed cognitive remediation is feasible and acceptable and to generate preliminary evidence regarding whether this approach may enhance engagement, generalization of learned strategies, and cognitive and psychosocial recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Informed Goal Management Training (TIGMT) | Active comparator | Behavioral: Trauma-Informed Goal Management Training (TIGMT)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. |
| Trauma Informed Goal Management Training - Assist (TIGMT-Assist) | Experimental | Behavioral: Trauma Informed Goal Management Training - Assist (TIGMT-Assist)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Trauma Informed Goal Management Training (TIGMT) |
| 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. | Behavioural | Trauma Informed Goal Management Training - Assist (TIGMT-Assist) |
Primary outcome
Change from baseline in symptom severity as assessed by the International Trauma Interview (ITI) at post-intervention.
Time frame: "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.
25 secondary outcomes
Demographic Information - Age
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Sex
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Education
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Relationship Status
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Employment Status
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Socioeconomic Status
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Profession
Time frame: Collected at "Baseline" only (Week 0)
Scores on the International Trauma Exposure Measure (ITEM) Assessing Past Trauma Exposure
Time frame: Administered at "Baseline" only (Week 0)
Change from baseline in score on the International Trauma Questionnaire (ITQ) at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in mental health diagnoses on the Diagnostic Research Assessment Tool (DART) at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Moral Injury Outcome Scale ('MIOS-F') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Scores on the Adverse Childhood Experiences International Questionnaire ('ACE-IQ') at baseline
Time frame: Collected at "Baseline" only (Week 0)
Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the Executive Skills Questionnaire-Revised (ESQ-R) at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on the Multidimensional Scale of Perceived Social Support (MSPSS) at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Sustained Attention at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Attention and Visual Searching at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Executive Function, Planning, and Working Memory at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Spatial Working Memory at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Spatial Planning at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Change from baseline in scores on a neuropsychological assessment measure of Episodic Memory at post-intervention
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 35326333Protopopescu 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.
- Background: PubMed 35884671Boyd 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.
- Background: PubMed 32440592Boyd 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Chrysler, BA (Hons) contact
Margaret McKinnon, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Goal Management Training (TIGMT) and Trauma Informed Goal Management Training - Assist (TIGMT-Assist) in people with Post Traumatic Stress, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Co-Lead (6476369963, brignalk@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptom severity as assessed by the International Trauma Interview (ITI) at post-intervention. (time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07797543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.