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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Satisfaction with Life Scale — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  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.
• Cognitive Failures Questionnaire — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  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.
• World Health Organization Quality of Life Scale-Brief — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  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.
• Multidimensional Scale of Perceived Social Support — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  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).
• General Self-Efficacy Scale — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The General Self-Efficacy Scale (GSES) is a 10-item self-report questionnaire measuring general beliefs in one's ability to cope with difficult situations and obstacles. Participants rate how true each statement is for them using a 4-point scale (1 = Not at all true, 2 = Hardly true, 3 = Moderately true, 4 = Exactly true). Total scores range from 10 to 40, calculated by summing all item responses. Higher scores indicate stronger general self-efficacy beliefs. The scale assesses optimistic self-beliefs about coping with demands in various life domains and has been shown to predict adaptation following stressful life events.
• Self-Efficacy Scale for Cognitive Remediation Therapy — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Self-Efficacy Scale for Cognitive Remediation Therapy (SE-CRT) is a 7-item self-report questionnaire measuring confidence in successfully completing cognitive remediation exercises. Participants rate their confidence level for each task using a 5-point scale (1 = Not at all confident, 2 = Slightly confident, 3 = Moderately confident, 4 = Very confident, 5 = Extremely confident). Items assess confidence in maintaining attention, using memory strategies, flexible problem-solving, applying strategies to daily life, time management, performing at average levels, and completing the entire treatment program. Total scores range from 7 to 35, with higher scores indicating greater treatment-specific self-efficacy.
• Continuous Performance Test with Rapid Automatized Naming — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Continuous Performance Test with Rapid Automatized Naming (CPT-RAN) is a computerized test of sustained attention and response inhibition from the ExecQC Battery administered via Pavlovia. Participants monitor a continuous stream of rapidly presented stimuli and respond to target stimuli while withholding responses to non-targets. The primary outcome is the d-prime (d') score, a signal detection measure that accounts for both hit rate and false alarm rate, providing a sensitivity index of discriminability between targets and non-targets. Scores typically range from 0 to 5+, with higher values indicating better sustained attention and vigilance. The test also yields reaction time and response consistency measures.
• Visual Search Task — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Visual Search Task (VST) is a computerized assessment of visual selective attention, processing speed and visual scanning ability from the ExecQC Battery administered via Pavlovia. Participants search for a target stimulus among distractors in visual arrays of varying complexity (set sizes). The primary outcomes are: (1) mean reaction time in milliseconds for correct target detection (lower = better performance), and (2) accuracy percentage (higher = better performance). The search slope (change in reaction time as set size increases) provides additional information about search efficiency and attentional capacity.
• Trail Making Test — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Trail Making Test (TMT) is a computerized version from the ExecQC Battery administered via Pavlovia, measuring processing speed, visual scanning and executive functions. Part A requires connecting numbered circles in ascending order (1-2-3...), assessing processing speed and visual attention. Part B requires alternating between numbers and letters (1-A-2-B-3-C...), assessing cognitive flexibility and set-shifting. Primary outcomes are completion times in seconds for each part (lower = better performance). The difference score (Part B minus Part A) isolates executive function independent of processing speed.
• Flanker Task — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Flanker Task (FT) is a computerized assessment of selective attention and inhibitory control from the ExecQC Battery administered via Pavlovia. Participants identify the direction of a central arrow while ignoring flanking arrows that are either congruent (pointing same direction) or incongruent (pointing opposite direction) with the target. The primary outcome is the Flanker interference effect: the difference in reaction time between incongruent and congruent trials (lower = better inhibitory control). Additional outcomes include overall accuracy and congruency effect on accuracy. This task measures the ability to suppress irrelevant information and maintain attention on task-relevant stimuli.
• Balloon Analogue Risk Task — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Balloon Analogue Risk Task (BART) is a computerized behavioral measure of risk-taking propensity and decision-making from the ExecQC Battery administered via Pavlovia. Participants inflate virtual balloons by pressing a key, earning points with each pump. Balloons have variable explosion points; if a balloon explodes, all points for that trial are lost. Participants can bank points at any time before explosion. The primary outcome is the adjusted average number of pumps on unexploded balloons, which reflects risk-taking behavior while controlling for random balloon explosion points. Higher scores indicate greater risk-taking. The task also yields measures of risk adjustment following losses and overall points earned.
• Rey Auditory Verbal Learning Test — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Rey Auditory Verbal Learning Test (RAVLT) is a neuropsychological test measuring verbal memory and learning administered remotely via secure Zoom videoconferencing. The examiner reads a 15-word list (List A) aloud five times through the video platform, and the participant verbally recalls as many words as possible after each presentation. The Total Learning Score is the sum of correctly recalled words across all five trials, ranging from 0 to 75, with higher scores indicating better verbal learning and immediate memory. After a 20-minute delay filled with other cognitive tasks, participants are asked to verbally recall as many words as possible from the original list without re-presentation (Delayed Recall Score, range 0-15). Higher delayed recall scores indicate better long-term verbal memory and consolidation. This remote administration format has been validated for telehealth neuropsychological assessment and maintains the psychometric properties of in-person administration.
• Symbol Digit Modalities Test — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Symbol Digit Modalities Test (SDMT) is a brief screening measure of processing speed, visual scanning, and sustained attention administered remotely via Zoom. Participants receive a paper copy of the test form with a key showing nine abstract symbols paired with digits 1-9 at the top, and rows of symbols below. On the examiner's verbal cue via video, participants write the corresponding digit below each symbol as quickly as possible for 90 seconds while the examiner monitors via video to ensure compliance. The score is the total number of correct symbol-digit pairings completed, with no penalty for errors. Scores typically range from 0 to approximately 110, with higher scores indicating faster processing speed. The written version is used for remote administration and has equivalent psychometric properties to oral administration.
• Emotional Stroop Test — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Emotional Stroop Test measures selective attention and inhibitory control in the context of emotionally valenced stimuli, administered remotely via Zoom with stimuli presented through screen sharing. Participants view colored words displayed on the examiner's shared screen and verbally name the ink color while ignoring the word content. The test includes three conditions: neutral words (e.g., "table," "chair"), general emotional words (positive/negative: e.g., "happy," "angry"), and trauma-related words specific to PTSD (e.g., "danger," "threat"). Response latencies are recorded. The interference score is calculated by subtracting the mean reaction time for neutral words from the mean reaction time for trauma-related words. Higher interference scores (in milliseconds) indicate greater difficulty inhibiting attention to trauma-relevant content and poorer attentional control. Remote administration via screen sharing maintains the essential attentional demands of the task.
• Verbal Fluency Test — Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)
  The Verbal Fluency Test is a neuropsychological assessment measuring phonemic and semantic verbal fluency, executive functions, and language production administered remotely via Zoom. The test consists of two conditions: (1) Phonemic Fluency - participants generate as many words as possible beginning with the letter "P" in 90 seconds, excluding proper nouns and words from the same word family; and (2) Semantic Fluency - participants generate as many animal names as possible in 90 seconds, regardless of starting letter. The examiner monitors via video and records responses at 15-second intervals. Primary outcomes are the total number of correct responses in 60 seconds for each condition (typically ranging from 0 to 25+ words for phonemic and 0 to 30+ words for semantic).

Trial sites (1)

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