Psychosocial Factors and Efficacy of Remote Cognitive Remediation for Post-Traumatic Stress Disorder

NCT ID: NCT07309302

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-03

Study Completion Date

2026-12-31

Brief Summary

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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 6 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.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cognitive Remediation Training

Cognitive Remediation Training

Group Type EXPERIMENTAL

Cognitive Remediation Training

Intervention Type BEHAVIORAL

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 (maximum six 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.

Video Games with Life Quality Support

Video Games with Quality of Life Support

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

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 (maximum of six 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.

Interventions

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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 (maximum six 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.

Intervention Type BEHAVIORAL

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 (maximum of six 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec a Montréal

OTHER

Sponsor Role lead

Responsible Party

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Pascale Brillon, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pavillon Adrien-Pinard (SU)

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Pascale Brillon Principal Investigator, Ph.D.

Role: CONTACT

(514) 987-3000 ext. 2313

Facility Contacts

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Pascale Brillon Principal Investigator

Role: primary

(514) 987-3000 ext. 2313

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-5811

Identifier Type: -

Identifier Source: org_study_id

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