Trauma-Informed Goal Management Training for Individuals With Post-traumatic Stress Disorder (PTSD)

NCT06354361 | Completed

• 1 other identifier: 17440
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of individuals experiencing symptoms of posttraumatic stress and posttraumatic stress disorder (PTSD). The goal of this clinical trial is to find out whether this modified, Trauma-Informed Goal Management Training program is effective for individuals experiencing symptoms associated with Post-Traumatic Stress Disorder. The main questions it aims to answer are:

• complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
• participate in a nine-week group treatment program (one day a week for two hours)
• complete four separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, a feedback interview, and completing a set of questionnaires
• complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires

Conditions

Post-Traumatic Stress Disorder

Keywords

Goal Management Training (GMT); Trauma-Informed Goal Management Training (TI-GMT)

Outcome Measures

Primary Outcomes (2)

• Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up

  A 30-item structured, clinician-administered interview used to make a lifetime or current diagnosis of PTSD and to assess PTSD symptoms. Questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms on social and occupational functioning, and specifications for the dissociative subtype. Total scores for severity may range between 0 and 80, with higher scores indicating greater symptom severity.

  Baseline, post-intervention at 9 weeks, and 3-month follow-up

• Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up

  A 'game-ified' Go/No-Go task that assesses sustained attention, this task requires participants to inhibit a behavioural response to a single, infrequent target appearing amidst a presentation of frequent non-targets. This task will be administering remotely, using Zoom for Healthcare (a PHIPA-compliant video conferencing platform) and Creyos (a web-based platform for assessing cognitive functioning). Scores are calculated based on accuracy of responses (errors) and reaction time (reaction time variability and slowing after errors). Higher scores on each indicate more errors, more variability in reaction time, and more slowing after an error, respectively. A percentile rank ranging between 1 and 99 is generated to indicate the individual's performance in comparison to a population of individuals of the same gender and age group.

  Baseline, post-intervention at 9 weeks, and 3-month follow-up

Secondary Outcomes (23)

• Demographic Information

  Collected at baseline only

• Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline

  Administered at baseline only

• Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline

  Administered at baseline only

• Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline

  Administered at baseline only

• Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up

  Baseline, post-intervention at 9 weeks, and 3-month follow-up

Study Arms (1)

Trauma-Informed GMT (TI-GMT; offered online)

EXPERIMENTAL

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

Behavioral: Trauma-Informed Goal Management Training (TI-GMT)

Interventions

Trauma-Informed Goal Management Training (TI-GMT) BEHAVIORAL

Trauma Informed-Goal Management Training (TI-GMT) is a modified version of Goal Management Training (GMT), a cognitive remediation program that emphasises mindfulness and practice in planning and completing goal-oriented behaviours. TI-GMT enhances the standard GMT protocol with the addition of several trauma-informed adaptations and content that is sensitive and specific to public safety personnel with PTSD. Participants are trained to interrupt ongoing disruptive behaviours through the resumption of executive control to help define goal hierarchies and monitor goal achievement. Mindfulness meditation helps develop attentional control and the skill of bringing one's mind to the present. Real-life examples are incorporated to illustrate goal attainment failures and successes, and participants practice solving complex, real-life tasks in sessions. Sessions include instructional material, interactive tasks, discussion of real-life deficits, and homework/practice activities.

Trauma-Informed GMT (TI-GMT; offered online)

Eligibility Criteria

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

You may qualify if:

• Be fluent in English;
• Must reside in Ontario;
• Be able to provide written informed consent;
• Be between the ages of 18 and 65 (in order to help us generalize results);
• Meet provisional diagnosis of PTSD using a cut-off of \>30 on the PCL-5, administered at the time of screening, to be corroborated with the results of the CAPS-5;
• Be able to attend regular online, 2-hour sessions once/week for 9 weeks, and be willing to complete the pre-, post-treatment, and follow-up assessments;
• Have access to a computer with a working microphone and camera, and have reliable and consistent internet;

You may not qualify if:

• Use benzodiazepines daily or almost daily;
• Use narcotics daily or almost daily;
• Endorse alcohol/substance use symptoms on the eligibility screener that may interfere with their ability to participate in the study, to be corroborated with the results of the M.I.N.I. (to be determined by Dr. McKinnon's 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 family unit;
• Have a history of 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 or bipolar disorder;
• Have a diagnosis of 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 (to be determined by Dr. McKinnon's clinical team)
• Have previously participated in GMT
• Be receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants
• Had ECT within the past year
• Are currently engaged in a trauma-specific intervention (EMDR, CPT, and PE) that may impact the findings of the current study (to be determined by Dr. McKinnon's clinical team)
• Is an active serving member of the Canadian Armed Forces

Sponsors & Collaborators

• McMaster University: lead
• Workplace Safety and Insurance Board: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L9C 1G2, Canada

Location

Related Publications (3)

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

  PMID: 32440592 BACKGROUND

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

  PMID: 35326333 BACKGROUND

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

  PMID: 35884671 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Margaret McKinnon, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants will be in the Trauma-Informed Goal Management Training condition, and receive nine sessions of Trauma-Informed Goal Management Training. Each group session will be 2 hours long, and offered virtually (using Zoom for Healthcare).

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: August 10, 2024
• Primary Completion: October 3, 2025
• Study Completion: November 3, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CA (1)