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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversité du Québec a Montréal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Remediation Training

    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 (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

    Other intervention

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Cognitive Remediation TrainingExperimental treatment 1 intervention
Group B: Video Games with Life Quality SupportPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Satisfaction with Life Scale

The Satisfaction with Life Scale (SWL) is a 5-item self-report questionnaire measuring global life satisfaction. Participants rate their agreement with life satisfaction statements using a 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). Total scores range from 5 to 35. Score interpretations: 5-9 (extremely dissatisfied), 10-14 (dissatisfied), 15-19 (slightly dissatisfied), 20 (neutral), 21-25 (slightly satisfied), 26-30 (satisfied), 31-35 (extremely satisfied). Higher scores indicate greater satisfaction with life.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
2

Cognitive Failures Questionnaire

The Cognitive Failures Questionnaire (CFQ) is a 25-item self-report measure assessing the frequency of cognitive lapses and everyday mistakes in memory, attention, and motor function over the past 6 months. Participants rate how often they experience each cognitive failure using a 5-point frequency scale (0 = Never, 1 = Very rarely, 2 = Occasionally, 3 = Quite often, 4 = Very often). Total scores range from 0 to 100, with higher scores indicating more frequent cognitive failures and perceived cognitive dysfunction in daily life. This measure captures subjective cognitive complaints that may not be detected by objective neuropsychological tests.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
3

World Health Organization Quality of Life Scale-Brief

The World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF) is a 26-item self-report questionnaire assessing four domains of quality of life: Physical Health (7 items, raw score range 7-35), Psychological Health (6 items, raw score range 6-30), Social Relationships (3 items, raw score range 3-15), and Environment (8 items, raw score range 8-40). Two additional items assess overall quality of life and general health. Participants rate items using 5-point Likert scales with varying response options (e.g., 1 = Very poor to 5 = Very good; 1 = Not at all to 5 = Completely). Domain scores are calculated by summing item responses and transforming to a 0-100 scale, where higher scores indicate better quality of life in that domain.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
4

Multidimensional Scale of Perceived Social Support

The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report questionnaire measuring perceived social support from three sources: family (4 items), friends (4 items), and significant other (4 items). Participants rate their agreement with each statement over the past 2 weeks using a 7-point Likert scale (1 = Very strongly disagree, 7 = Very strongly agree). The total score ranges from 12 to 84, calculated by summing all item responses. Higher scores indicate greater perceived social support. Score interpretations: 12-36 (low support), 37-60 (moderate support), 61-84 (high support). Subscale scores can also be calculated for each support source (range: 4-28 per subscale).

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)

Secondary outcomes

1

PTSD Checklist for DSM-5

The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire assessing PTSD symptom severity based on DSM-5 criteria. Participants rate how much they have been bothered by each PTSD symptom over the past month using a 5-point Likert scale (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Total scores range from 0 to 80. Higher scores indicate greater PTSD symptom severity. A score of 33 or higher suggests probable PTSD diagnosis. The PCL-5 assesses four symptom clusters: intrusion symptoms, avoidance, negative alterations in cognitions and mood, and alterations in arousal and reactivity.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
2

Patient Health Questionnaire-9

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire measuring depression severity based on DSM-5 criteria. Participants rate how often they have been bothered by depressive symptoms over the past two weeks using a 4-point scale (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). Total scores range from 0 to 27. Score interpretations: 0-4 (minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe depression). Higher scores indicate greater depression severity.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
3

Generalized Anxiety Disorder-7

The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire measuring generalized anxiety disorder symptom severity. Participants rate how often they have been bothered by anxiety symptoms over the past two weeks using a 4-point scale (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). Total scores range from 0 to 21. Score interpretations: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety). Higher scores indicate greater anxiety severity.

Time frame
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
4

Strategy Use Questionnaire - Frequency of Strategy Application

A brief questionnaire administered at 3-month follow-up assessing whether participants continued to apply cognitive strategies learned during the intervention. Participants indicate: (1) whether they have used any exercises or strategies since treatment completion (Yes/No), (2) if yes, the approximate number of times they have used them (0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20+ times), and (3) an open-ended description of which specific strategies they have used. This measure captures maintenance of treatment effects and real-world application of learned compensatory strategies, which may mediate long-term outcomes.

Time frame
3-month follow-up only (Week 20)

Other outcomes

1

Weekly self-report of alcohol, drug, or non-prescribed medication use frequency

Participants complete a brief weekly questionnaire assessing substance use over the past week using a 4-point scale (0 = Never, 1 = A few days, 2 = More than half the days, 3 = Every day). This safety monitoring measure tracks potential increases in maladaptive coping behaviors during the intervention period. Significant increases in substance use may indicate treatment-related distress requiring clinical attention.

Time frame
Weekly throughout 8-week intervention (Weeks 1-8)
2

Weekly self-report of suicidal ideation frequency (PHQ-9 Item 9)

Participants complete PHQ-9 item 9 weekly, rating how often they have had thoughts that they would be better off dead or of hurting themselves over the past week using a 4-point scale (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). This safety monitoring measure tracks suicidal ideation throughout the intervention. Any positive response triggers the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment to evaluate risk level and implement safety protocols as needed.

Time frame
Weekly throughout 8-week intervention (Weeks 1-8)
3

Weekly self-report of number of psychotherapy sessions attended

Participants report the number of psychotherapy sessions attended during the past week (0, 1, 2, 3, 4, or 5+ sessions). This measure tracks concurrent psychological treatment that may influence outcomes. Note: Cognitive remediation sessions are explicitly excluded from this count. This variable will be included as a covariate in outcome analyses to account for the potential additive or interactive effects of concurrent psychotherapy on cognitive and psychological outcomes.

Time frame
Weekly throughout 8-week intervention (Weeks 1-8)
4

Weekly self-report of any changes in psychiatric medications

Participants report any changes in psychiatric medications each week (Yes/No). If yes, they provide details about medication additions, discontinuations, or dose modifications, including medication names and dosages. This measure monitors potential medication changes that may influence treatment outcomes. Significant medication changes will be documented and considered in outcome analyses.

Time frame
Weekly throughout 8-week intervention (Weeks 1-8)

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