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

Official title

Psychosocial Determinants and Impact of a Synchronous Remote Cognitive Remediation Program on Individuals With Post-Traumatic Stress Disorder.

Overview

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.

Interventions

• Behavioral 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 (se
• Other 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

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• PTSD Checklist for DSM-5 [Time frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)]
• Patient Health Questionnaire-9 [Time frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)]
• Generalized Anxiety Disorder-7 [Time frame: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20)]
• Strategy Use Questionnaire - Frequency of Strategy Application [Time frame: 3-month follow-up only (Week 20)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Pavillon Adrien-Pinard (SU) — Montreal

Publications

• Ainamani HE, Elbert T, Olema DK, Hecker T. PTSD symptom severity relates to cognitive and psycho-social dysfunctioning - a study with Congolese refugees in Uganda. Eur J Psychotraumatol. 2017 Feb 14;8(1):1283086. doi: 10.1080/20008198.2017.1283086. eCollection 2017. PMID 28326164
• Alioto AG, Kramer JH, Borish S, Neuhaus J, Saloner R, Wynn M, Foley JM. Long-term test-retest reliability of the California Verbal Learning Test - second edition. Clin Neuropsychol. 2017 Nov;31(8):1449-1458. doi: 10.1080/13854046.2017.1310300. Epub 2017 Apr 7. PMID 28387582
• Alon Y, Naim R, Pine DS, Bliese PD, Bar-Haim Y. Validity of Attention Bias Variability Indices for Posttraumatic Stress Disorder Research: Evidence From Patient Data. J Trauma Stress. 2019 Oct;32(5):791-798. doi: 10.1002/jts.22443. Epub 2019 Aug 28. PMID 31461560
• American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
• Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016. PMID 27723815
• Aupperle RL, Allard CB, Grimes EM, Simmons AN, Flagan T, Behrooznia M, Cissell SH, Twamley EW, Thorp SR, Norman SB, Paulus MP, Stein MB. Dorsolateral prefrontal cortex activation during emotional anticipation and neuropsychological performance in posttraumatic stress disorder. Arch Gen Psychiatry. 2012 Apr;69(4):360-71. doi: 10.1001/archgenpsychiatry.2011.1539. PMID 22474105
• Balzan RP, Mattiske JK, Delfabbro P, Liu D, Galletly C. Individualized Metacognitive Training (MCT+) Reduces Delusional Symptoms in Psychosis: A Randomized Clinical Trial. Schizophr Bull. 2019 Jan 1;45(1):27-36. doi: 10.1093/schbul/sby152. PMID 30376124
• Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall.

Identifiers

NCT: NCT07309302 · 2024-5811

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗