[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693686":3,"trial-entities:NCT07693686":98,"trial-summary:NCT07693686":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":71,"locations":74,"central_contacts":92,"overall_officials":94,"references":96,"see_also_links":97},"NCT07693686","RRD4-010-25W","Cognitive Training for Functioning in PTSD","Cognitive Training to Address Functioning and Symptoms in Veterans With Posttraumatic Stress Disorder","NOT_YET_RECRUITING","2030-03-31","2026-07","2026-07-16","2027-07-01","VA Office of Research and Development","FED",false,"The proposed study will test a novel, computerized treatment for posttraumatic stress disorder (PTSD) to determine if it helps Veterans functionally recover as measured by reduced cognitive disability and PTSD symptoms. To do so, investigators will evaluate the effects of a cognitive training program that is designed to improve people's ability to manage information in working memory. Investigators will measure self-reported symptoms and disability alongside day-to-day cognition and functioning. The project support the VA Office of Research and Development's mission to improve Veteran participation in their lives and community by determining if this new approach can improve recovery from trauma and exploring for whom the intervention works.","Posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition among Veterans, associated with high healthcare utilization, physical comorbidities, and increased suicide risk. Despite the effectiveness of first-line psychotherapies for PTSD, these treatments do not universally address the neuropsychological deficits often seen in PTSD, such as impaired executive functioning, which contributes to both poor functional recovery and exacerbation of symptoms. There is a critical need for novel interventions targeting executive functioning to complement existing therapies and improve outcomes. The investigator team has developed Cognitive ENhancement Training (COGENT), a low-burden, computer-based neurotherapeutic program designed to improve executive functioning. Preliminary data suggest COGENT may improve cognitive and affective symptoms in Veterans with PTSD, but larger, rigorous trials are needed to assess its clinical utility.\n\nCOGENT represents a promising innovation in PTSD treatment by focusing on enhancing executive functioning, which is directly implicated in the regulation of PTSD symptoms. Unlike existing therapies, COGENT targets cognitive deficits that drive symptom severity using a relatively brief, computer-administered format, offering a potential alternative pathway for improving recovery. If successful, this intervention could provide a scalable, cost-effective, and easily integrated treatment for Veterans with PTSD, improving their daily functioning and reducing symptom burden.\n\nSpecific Aims: 1) Evaluate the impact of COGENT on clinical functioning and PTSD symptoms. Investigators hypothesize that COGENT will lead to significant reductions in cognitive disability and re-experiencing symptoms relative to a control group. 2) Assess the real-world effects of COGENT on cognitive, emotional, and functional outcomes using smartphone-based ecological momentary assessments. Investigators hypothesize that COGENT will improve cognitive performance, reduce mood symptoms, and decrease functional impairment in everyday settings. Exploratory Aim) Identify predictors of treatment outcomes. This will explore how baseline cognitive performance and sociodemographic and clinical characteristics (e.g., traumatic brain injury history) influence the response to COGENT.\n\nSuccessful outcomes from this will support the translation of COGENT into VA care. If effective, COGENT could be either provided as direct-to-Veteran services or integrated into routine clinical practice within the existing PTSD treatment programs as a cost-effective, widely accessible option for improving cognitive and clinical outcomes. Further research will explore potential for widespread dissemination and individual-level tailoring to optimize treatment benefits for Veterans with PTSD.",[19],"Posttraumatic Stress Disorder",[21,22],"Posttraumatic stress disorder","traumatic stress","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},176,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","COGENT (Cognitive ENhancement Training)","COGENT is a computer-administered cognitive training program and consists of a modified working memory capacity task. COGENT was designed to contain high interference across trials, and requires participants to consistently, actively manage control over working memory interference. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems used to manage how information enters and subsequently is removed from working memory, leading to improved performance over time.",[36],"Cognitive ENhancement Training (COGENT)",{"type":32,"name":38,"description":39,"armGroupLabels":40},"ST (Sham Training)","The sham training (ST) requires participants to remember the same total number of items as in COGENT; however, this training contains relatively less proactive interference across trials and is designed to be an \"inert\" version of the experimental program. The sham training condition will allow us to evaluate differences based on the proposed working memory interference training element, rather than general elements of the task (e.g., regular staff contact, contact time, general computer interface time).",[41],"Sham Training (ST)",[43],{"measure":44,"description":45,"timeFrame":46},"Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain","The WHODAS is a widely used, standardized tool designed to assess the level of disability experienced by individuals across various health conditions, including mental health disorders like PTSD. The WHODAS measures disability across six domains of functioning. The current project will utilize the cognition domain score to measure cognitive disability. A simple score for the WHODAS 2.0 ranges from 36-180 with higher scores indicating the degree of functional limitations.","baseline, post (week 10), 3-month follow-up, 6-month follow-up",[48],{"measure":49,"description":50,"timeFrame":46},"Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale","The CAPS-5 semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptom severity. Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.","ALL","18 Years",null,{"inclusion":55,"exclusion":60,"raw_text":70},[56,57,58,59],"diagnosis of PTSD","presence of subjective cognitive complaints","fluent in English","willing to attend assessment and treatment sessions",[61,62,63,64,65,66,67,68,69],"past year history of psychotic or bipolar I disorders","past year history of severe alcohol or substance use disorder","history of severe traumatic brain injury or other known neurological condition that may be associated with cognitive dysfunction","acute suicidality necessitating immediate clinical intervention (within past 3 months)","presence of circumstances that require imminent intervention prior to other treatment (e.g., current domestic abuse)","plans for medication changes within the study timeframe","current or planned evidence-based psychotherapy for PTSD within the study timeframe","plans for changes to other psychosocial therapy within the study timeframe","presence of life-threatening or unstable medical conditions","Inclusion Criteria:\n\n* diagnosis of PTSD\n* presence of subjective cognitive complaints\n* fluent in English\n* willing to attend assessment and treatment sessions\n\nExclusion Criteria:\n\n* past year history of psychotic or bipolar I disorders\n* past year history of severe alcohol or substance use disorder\n* history of severe traumatic brain injury or other known neurological condition that may be associated with cognitive dysfunction\n* acute suicidality necessitating immediate clinical intervention (within past 3 months)\n* presence of circumstances that require imminent intervention prior to other treatment (e.g., current domestic abuse)\n* plans for medication changes within the study timeframe\n* current or planned evidence-based psychotherapy for PTSD within the study timeframe\n* plans for changes to other psychosocial therapy within the study timeframe\n* presence of life-threatening or unstable medical conditions",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":89},"VA San Diego Healthcare System, San Diego, CA","San Diego","California","92161-0002","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Jessica A Bomyea, PhD","CONTACT","(858) 642-3720","jessica.bomyea@va.gov",{"name":83,"role":88},"PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},32.71571,-117.16472,[93],{"name":83,"role":84,"phone":85,"email":86},[95],{"name":83,"affiliation":76,"role":88},[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":103,"summary":104,"prompt_version":113},true,{"design":105,"status":106,"heading":6,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This study is an interventional study planning to enroll 176 participants. It compares COGENT to a sham training (ST) program.","completed","This study is testing a new computer program called COGENT (Cognitive ENhancement Training) for people with Posttraumatic Stress Disorder (PTSD). COGENT is designed to improve your ability to manage information in your working memory, which may help with daily functioning and PTSD symptoms. Researchers want to see if COGENT helps Veterans recover better by reducing cognitive disability and PTSD symptoms. You might be able to join if you have a PTSD diagnosis, experience cognitive complaints, speak English, and are willing to attend study sessions. The study will measure changes in your daily functioning and cognitive abilities over time. The current recruitment status is unclear.","Participants will be followed for 6 months after treatment.",104,"You would attend assessment and treatment sessions. The study measures outcomes at baseline, after 10 weeks of treatment, and at 3-month and 6-month follow-ups.","Not stated in the trial record.",[33],"v2"]