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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
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.
McMaster University
Hamilton, Ontario, Canada
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)
Demographic Information - Age
Age, collected numerically in years (e.g., 29 years old).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Socioeconomic Status
Collected qualitatively from a list of options (income ranges).
Time frame: Collected at "Baseline" only (Week 0)
Demographic Information - Profession
Collected qualitatively, with an open-text field.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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