Recruiting

Cognitive Training

Sponsor:

Université du Québec a Montréal

Code:

NCT07309302

Conditions

Post Traumatic Stress Disorder PTSD

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Cognitive Remediation Training

Control Group

Study Details

Brief summary:

The goal of this clinical trial is to evaluate whether computer-based brain training can help adults with post-traumatic stress disorder (PTSD). Individuals with PTSD often experience difficulties with memory, attention, concentration, and problem-solving, which can significantly affect their daily lives, work performance, and overall quality of life. These cognitive challenges can hinder trauma recovery and reduce the effectiveness of standard PTSD treatments.

The main questions this study seeks to address are:

Does specialized brain training improve PTSD symptoms compared to regular computer games? Does brain training enhance cognitive functions such as memory, attention, processing speed, and executive functioning? Does brain training improve quality of life and daily functioning? Do participants' self-efficacy and perceived social support influence treatment outcomes?

Researchers will compare two approaches: a specialized cognitive training program (HAPPYneuron Pro) with strategy teachings and quality-of-life discussions, versus engaging computer games with quality-of-life discussions, to determine which is more effective for people with PTSD.

Study Design

Participants will be randomly assigned to one of two groups for an 8-week program:

Cognitive remediation training group: Complete computerized cognitive exercises and strategy teachings specifically designed to strengthen memory, attention, and executive functions, combined with quality-of-life discussions.

Control group: Complete engaging computer games combined with quality-of-life discussions.

Schedule

Both groups will follow the same schedule:

One online session per week, in small and consistent groups of 4-8 participants. Each 60-minute session consists of 30 minutes of computer activities followed by 45 minutes of group discussion.

One at-home individual homework exercise per week (30 minutes at home).

Total time commitment: 1h45 per week for 8 weeks.

Assessments All participants will complete three comprehensive assessment sessions: before treatment, immediately after the 8-week program, and 3 months later. Assessments include neuropsychological testing and questionnaires on PTSD symptoms, depression, anxiety, quality of life, satisfaction with life, social support, cognitive failures, and self-efficacy.

Significance This research evaluates a new, accessible and remotely deliverable approach for PTSD treatment. Current evidence-based treatments often do not directly target the cognitive impairments experienced by many individuals with PTSD.

Compensation Participants will receive $35 for each completed assessment (maximum $105). Control group participants will gain access to the cognitive remediation training program after completing their participation.

Conditions

Post Traumatic Stress Disorder PTSD

Study ID

NCT07309302

Start date

Aug 3, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Age 18 to 45 years
  • Able to speak and read French fluently
  • Access to a computer with a camera and a secure Internet connection
  • Access to a private space for assessment and intervention sessions
  • Available for the complete treatment protocol
  • Confirmed current PTSD diagnosis using the Structured Clinical Interview for DSM-5 (SCID-5)
  • Residing in Canada

Exclusion Criteria

  • History of neurological disorders (stroke, intracranial surgery, aneurysm, epilepsy)
  • Moderate to severe traumatic brain injury OR hospitalization due to traumatic brain injury
  • Mild traumatic brain injury less than 6 months ago with persistent symptoms
  • Psychotic disorders
  • Alcohol abuse or substance dependence disorders
  • Video game addiction
  • Hospitalization for major depression or suicide risk within the past 3 months
  • Regular use of medications that impact neurocognition, including: benzodiazepines (diazepam, lorazepam, alprazolam, Ativan, Xanax, Rivotril)
  • Residence outside Canada

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Remediation Training

Cognitive Remediation Training

placebo comparator: Video Games with Life Quality Support

Video Games with Quality of Life Support

Interventions

Cognitive Remediation Training

Cognitive Remediation Training: Eight-week remote program using HAPPYneuron Pro software targeting attention, verbal memory, processing speed, and executive functions.

Participants attend weekly 75-minute group sessions (four to eight participants) via videoconferencing: 30 minutes of computerized cognitive exercises and 45 minutes of guided discussion on metacognitive strategies and quality-of-life topics. Weekly homework assignments (45 minutes) reinforce skills. Sessions target attention (selective, sustained, divided), verbal memory (encoding, recall, recognition), and executive functions (planning, problem-solving, cognitive flexibility, inhibition).

Strategy teachings address attention, verbal memory, planning, problem-solving, emotion regulation, meditation, and cognitive flexibility. Quality of life discussions (summarized format) cover sleep, nutrition, physical activity, social support, cultural activities, nature-based activities, relaxation, and substance use behaviors.

Control Group

Video Games with Quality of Life Support: Eight-week active control program combining commercial video games with quality of life discussions. Participants will attend weekly 75-minute group sessions via secure videoconferencing (four to eight participants) , consisting of 30 minutes of entertaining computer games from the Poki.com platform (games include Bubbles, Sweet World, Minesweeper, etc.) and 45 minutes of group discussions on healthy lifestyle topics including sleep, nutrition, physical activity, social support, cultural activities, nature-based activities, relaxation, and substance use behaviors. Weekly individual gaming assignments (30 minutes) maintain engagement. Games are selected for entertainment value without proven cognitive benefits. Discussions focus on general wellness and lifestyle factors rather than cognitive strategy development.

Primary outcome measure

  • Satisfaction with Life Scale [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Cognitive Failures Questionnaire [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • World Health Organization Quality of Life Scale-Brief [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Multidimensional Scale of Perceived Social Support [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • General Self-Efficacy Scale [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Self-Efficacy Scale for Cognitive Remediation Therapy [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Continuous Performance Test with Rapid Automatized Naming [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Visual Search Task [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Trail Making Test [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Flanker Task [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Balloon Analogue Risk Task [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Rey Auditory Verbal Learning Test [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Symbol Digit Modalities Test [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Emotional Stroop Test [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]
  • Verbal Fluency Test [ Time Frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20) ]

Central Contacts and Locations

Central contacts

Pascale Brillon Principal Investigator, Ph.D.

(514) 987-3000brillon.pascale@uqam.ca

Locations

Pavillon Adrien-Pinard (SU)

Recruiting

Montreal, Quebec, Canada, H2X 3P2

Contacts

Pascale Brillon Principal Investigator

(514) 987-3000brillon.pascale@uqam.ca

More Information

Sponsor

Université du Québec a Montréal

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Cognitive remediation
  • Social Support
  • Quality of Life
  • Online Intervention
  • Self-Efficacy
  • Depression
  • Anxiety
  • Attention
  • Verbal Memory
  • Executive Functions
  • Life Satisfaction
  • Post-Traumatic Stress Disorder
  • Neuropsychological functions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université du Québec a Montréal on 2026-05-18.