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

27 de agosto de 2026 atualizado por: Margaret McKinnon, McMaster University

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.

Visão geral do estudo

Status

Status

Indica o status de recrutamento atual ou o status de acesso expandido.
Ainda não está recrutando

Condições

Condições

A doença, distúrbio, síndrome, doença ou lesão que está sendo estudada. Em ClinicalTrials.gov, as condições também podem incluir outros problemas relacionados à saúde, como expectativa de vida, qualidade de vida e riscos à saúde.

Intervenção / Tratamento

Intervenção / Tratamento

Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.

Descrição detalhada

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.

Tipo de estudo

Tipo de estudo

Descreve a natureza de um estudo clínico. Os tipos de estudo incluem estudos intervencionais (também chamados de ensaios clínicos), estudos observacionais (incluindo registros de pacientes) e acesso expandido.
Intervencional

Inscrição (Estimado)

Inscrição

O número de participantes em um estudo clínico. A inscrição "antecipada" é o número alvo de participantes que os pesquisadores precisam para o estudo.
64

Estágio

Estágio

A etapa de um ensaio clínico que estuda um medicamento ou produto biológico, com base nas definições desenvolvidas pela Food and Drug Administration (FDA) dos EUA. A fase é baseada no objetivo do estudo, no número de participantes e em outras características. Existem cinco fases: Fase Inicial 1 (anteriormente listada como Fase 0), Fase 1, Fase 2, Fase 3 e Fase 4. Não Aplicável é usado para descrever ensaios sem fases definidas pela FDA, incluindo ensaios de dispositivos ou intervenções comportamentais.
  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Contato de estudo

O nome e as informações de contato da pessoa que pode responder às perguntas de inscrição para um estudo clínico. Cada local onde o estudo está sendo realizado também pode ter um contato específico, que pode responder melhor a essas perguntas.

Estude backup de contato

Locais de estudo

  • Canadá
    • Ontario
      • Hamilton, Ontario, Canadá, L9C 1G2
        • McMaster University
        • Contato:
        • Contato:
        • Investigador principal:
          • Margaret McKinnon, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Critérios de elegibilidade

Os principais requisitos que as pessoas que desejam participar de um estudo clínico devem atender ou as características que devem ter. Os critérios de elegibilidade consistem em critérios de inclusão (que são necessários para que uma pessoa participe do estudo) e critérios de exclusão (que impedem uma pessoa de participar). Tipos de critérios de elegibilidade incluem se um estudo aceita voluntários saudáveis, tem requisitos de idade ou faixa etária ou é limitado por sexo.

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • use benzodiazepines daily or almost daily
  • use narcotics daily or almost daily
  • meet criteria for Alcohol/Cannabis use that may interfere with their ability to participate in the study, as assessed by the AUDIT and CUDIT-R embedded into the eligibility pre-screener and corroborated with the DART (to be determined by the clinical team)
  • have a history of Moderate to Severe brain injury or loss of consciousness with prolonged effects that interfere with daily functioning at school, work, or within the family unit
  • have a history of a neurological disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team)
  • have a diagnosis of psychotic disorder, borderline personality disorder, or bipolar disorder
  • have a diagnosis of a neurodevelopmental disorder that may interfere with their ability to participate in the study (to be determined by Dr. McKinnon's clinical team)
  • have other conditions/impairments/considerations that could interfere with completion of study tasks or participation in the study (to be determined by Dr. McKinnon's clinical team)
  • have previously participated in GMT
  • are receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants
  • have had ECT within the past year
  • are currently engaged in a trauma-focused intervention that may confound the findings of the current study (to be determined by Dr. McKinnon's clinical team)
  • are an active serving member of the Canadian Armed Forces.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço

Grupo de Participantes / Braço

Um grupo ou subgrupo de participantes em um estudo clínico que recebe uma intervenção/tratamento específico, ou nenhuma intervenção, de acordo com o protocolo do estudo.
Intervenção / Tratamento

Intervenção / Tratamento

Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.
Comparador Ativo: 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.
Comportamental: 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.
Experimental: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medidas de resultados primários

No protocolo de um estudo clínico, a medida de resultado planejada que é a mais importante para avaliar o efeito de uma intervenção/tratamento. A maioria dos estudos clínicos tem uma medida de desfecho primário, mas alguns têm mais de uma.
Medida de resultado
Descrição da medida
Prazo
Change from baseline in symptom severity as assessed by the International Trauma Interview (ITI) at post-intervention.
Prazo: "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.
"Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)

Medidas de resultados secundários

Medidas de resultados secundários

No protocolo de um estudo clínico, uma medida de resultado planejada que não é tão importante quanto a medida de resultado primária para avaliar o efeito de uma intervenção, mas ainda é de interesse. A maioria dos estudos clínicos tem mais de uma medida de desfecho secundário.
Medida de resultado
Descrição da medida
Prazo
Demographic Information - Age
Prazo: Collected at "Baseline" only (Week 0)
Age, collected numerically in years (e.g., 29 years old).
Collected at "Baseline" only (Week 0)
Demographic Information - Sex
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Collected at "Baseline" only (Week 0)
Demographic Information - Education
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Collected at "Baseline" only (Week 0)
Demographic Information - Relationship Status
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Collected at "Baseline" only (Week 0)
Demographic Information - Employment Status
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively from a list of options, including "other not listed above" with an open-text field.
Collected at "Baseline" only (Week 0)
Demographic Information - Socioeconomic Status
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively from a list of options (income ranges).
Collected at "Baseline" only (Week 0)
Demographic Information - Profession
Prazo: Collected at "Baseline" only (Week 0)
Collected qualitatively, with an open-text field.
Collected at "Baseline" only (Week 0)
Scores on the International Trauma Exposure Measure (ITEM) Assessing Past Trauma Exposure
Prazo: Administered at "Baseline" only (Week 0)
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.
Administered at "Baseline" only (Week 0)
Change from baseline in score on the International Trauma Questionnaire (ITQ) at post-intervention
Prazo: "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 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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: Collected at "Baseline" only (Week 0)
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.
Collected at "Baseline" only (Week 0)
Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"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
Prazo: "Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)
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.
"Baseline" (Week 0) and "Post-intervention" (immediately after completing the intervention: Week 9 for TIGMT condition, Week 12 for TIGMT-Assist condition)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Patrocinador

A organização ou pessoa que inicia o estudo e que tem autoridade e controle sobre o estudo.
McMaster University

Investigadores

Investigadores

Um pesquisador envolvido em um estudo clínico. Os termos relacionados incluem investigador principal do centro, subinvestigador do centro, coordenador do estudo, diretor do estudo e investigador principal do estudo.
  • Investigador principal: Margaret McKinnon, PhD, McMaster University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

Início do estudo

A data real em que o primeiro participante foi inscrito em um estudo clínico. A data de início do estudo "antecipada" é a data que os pesquisadores acham que será a data de início do estudo.
1 de setembro de 2026

Conclusão Primária (Estimado)

Conclusão Primária

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção para coletar dados finais para a medida de resultado primário. Se o estudo clínico terminou de acordo com o protocolo ou foi encerrado, não afeta esta data. Para estudos clínicos com mais de uma medida de resultado primário com diferentes datas de conclusão, este termo refere-se à data em que a coleta de dados é concluída para todas as medidas de resultado primário. A data de conclusão primária "antecipada" é a data que os pesquisadores acham que será a data de conclusão primária do estudo.
1 de março de 2027

Conclusão do estudo (Estimado)

Conclusão do estudo

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção/tratamento para coletar dados finais para as medidas de resultado primário, medidas de resultado secundário e eventos adversos (ou seja, a última visita do último participante). A data "prevista" de conclusão do estudo é a data que os pesquisadores acham que será a data de conclusão do estudo.
1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez

A data em que o patrocinador ou investigador do estudo enviou pela primeira vez um registro do estudo para ClinicalTrials.gov. Normalmente, há um atraso de alguns dias entre a primeira data de envio e a disponibilidade do registro em ClinicalTrials.gov (a primeira data publicada).
10 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

Enviado pela primeira vez que atendeu aos critérios de CQ

A data em que o patrocinador ou investigador do estudo envia pela primeira vez um registro do estudo que seja consistente com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). O patrocinador ou investigador pode precisar revisar e enviar um registro de estudo uma ou mais vezes antes que os critérios de revisão de QC do NLM sejam atendidos. É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
27 de agosto de 2026

Primeira postagem (Real)

Primeira postagem

A data em que o registro do estudo foi disponibilizado pela primeira vez em ClinicalTrials.gov após a conclusão da revisão do controle de qualidade (QC) da National Library of Medicine (NLM). Normalmente, há um atraso de alguns dias entre a data em que o patrocinador ou investigador do estudo enviou o registro do estudo e a primeira data publicada.
1 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última Atualização Postada

A data mais recente em que as alterações em um registro de estudo foram disponibilizadas em ClinicalTrials.gov. Pode haver um atraso entre o momento em que as alterações foram enviadas ao ClinicalTrials.gov pelo patrocinador ou investigador do estudo (a última data de envio de atualização) e a data de publicação da última atualização.
1 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última atualização enviada que atendeu aos critérios de controle de qualidade

A data mais recente em que o patrocinador ou investigador do estudo enviou alterações em um registro do estudo que são consistentes com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
27 de agosto de 2026

Última verificação

Última verificação

A data mais recente em que o patrocinador ou investigador do estudo confirmou as informações sobre um estudo clínico no ClinicalTrials.gov como precisas e atuais. Se um estudo com status de recrutamento de recrutamento; ainda não está recrutando; ou ativo, não recrutando não foi confirmado nos últimos 2 anos, o status de recrutamento do estudo é mostrado como desconhecido.
1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

Outros números de identificação do estudo

Identificadores ou números de identificação diferentes do número NCT que são atribuídos a um estudo clínico pelo patrocinador, financiadores ou outros do estudo. Esses números podem incluir identificadores exclusivos de outros registros de ensaios e números de concessão do National Institutes of Health.
  • 19577 (Outro identificador: HiREB)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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