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

Université du Québec a Montréal

Status: Enrolling

Conditions: Post Traumatic Stress Disorder PTSD

Treatments: Other: Control Group; Behavioral: Cognitive Remediation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07309302

2024-5811

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Cognitive Remediation Training

Experimental group

Description:

Cognitive Remediation Training

Treatment:

Behavioral: Cognitive Remediation Training

Video Games with Life Quality Support

Placebo Comparator group

Description:

Video Games with Quality of Life Support

Treatment:

Other: Control Group