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

Browse trials for

• Combat Disorders 200
• Depression 8,577
• Anxiety Disorders 7,201
• Personal Satisfaction 541
• Stress Disorders, Post-Traumatic 2,682

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

Combat Disorders

200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.

This study's planned enrollment of 64 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.

Lead sponsor

Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Study arms

• Experimental
  Cognitive Remediation Training

  Cognitive Remediation Training

  Behavioral: Cognitive Remediation Training

• Placebo comparator
  Video Games with Life Quality Support

  Video Games with Quality of Life Support

  Other: Control Group

Interventions

• BehavioralCognitive 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.

• OtherControl 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 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)

5. General Self-Efficacy Scale

   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.

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

6. Self-Efficacy Scale for Cognitive Remediation Therapy

   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.

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

7. Continuous Performance Test with Rapid Automatized Naming

   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.

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

8. Visual Search Task

   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.

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

9. Trail Making Test

   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.

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

10. Flanker Task

    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.

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

11. Balloon Analogue Risk Task

    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.

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

12. Rey Auditory Verbal Learning Test

    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.

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

13. Symbol Digit Modalities Test

    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.

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

14. Emotional Stroop Test

    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.

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

15. Verbal Fluency Test

    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).

    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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