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Cognitive Training for Functioning in PTSD

14 luglio 2026 aggiornato da: VA Office of Research and Development

Cognitive Training to Address Functioning and Symptoms in Veterans With Posttraumatic Stress Disorder

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

COGENT 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.

Specific 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.

Successful 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

176

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • California
      • San Diego, California, Stati Uniti, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Contatto:
        • Investigatore principale:
          • Jessica A Bomyea, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • diagnosis of PTSD
  • presence of subjective cognitive complaints
  • fluent in English
  • willing to attend assessment and treatment sessions

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cognitive ENhancement Training (COGENT)
Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).
Comportamentale: 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.
Comparatore fittizio: Sham Training (ST)
Participants will be Veterans assigned to the sham training comparator (ST), a non-training cognitive program matched for time and memory demands.
Comportamentale: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
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.
baseline, post (week 10), 3-month follow-up, 6-month follow-up

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline neuropsychological performance
Lasso di tempo: baseline, post (week 10)
A brief neuropsychological test battery will be used to predict response to the study intervention, based on evidence from previous work demonstrating that individuals with lower initial cognitive functioning may experience greater improvement in symptoms. The neuropsychological battery will consist of the Delis-Kaplan Executive Functioning System (DKEFS) Verbal Fluency, TestMyBrain (TMB) Trails, TMB Digit Symbol Matching and Choice Reaction Time, Wechsler Adult Intelligence Scale-IV (WAIS-IV) (Digit Span, Letter Number Sequencing), AX Continuous Performance Test from the Cognitive Neuroscience Test Reliability and Clinical applications for Schizophrenia (CNTRaCS) battery, and the California Verbal Learning Test-II (CVLT-II). The Montreal Cognitive Assessment (MoCA) screening will also be administered. All measures will be scored using published norms and a composite z-score by domain will be calculated, with higher scores indicating greater cognitive performance.
baseline, post (week 10)
Anxiety symptoms
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Change from baseline in anxiety symptoms as measured by General Anxiety Disorder 7 (GAD-7), as part of measuring broad clinical effects. The total score ranges from 0-21, with higher scores indicating higher levels of anxiety symptoms.
baseline, post (week 10), 3-month follow-up, 6-month follow-up
Depression symptoms
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Change from baseline in depression symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9), as part of measuring broad clinical effects. The total score ranges from 0-27, with higher scores indicating higher levels of depressive symptoms.
baseline, post (week 10), 3-month follow-up, 6-month follow-up
Suicide risk level
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
The Columbia Suicide Severity Risk Scale (CSSRS) will be used to measure suicide risk level at all time points, as part of measuring broad clinical effects.
baseline, post (week 10), 3-month follow-up, 6-month follow-up
Impulsivity
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Change in impulsivity as measured by the Barratt Impulsiveness Scale (BIS), as part of measuring broad clinical effects. The total score ranges from 30-120, with higher scores indicating higher levels of impulsivity.
baseline, post (week 10), 3-month follow-up, 6-month follow-up
Global functioning (WHODAS 2.0)
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Change in global functional impairment related to social and life responsibilities will be measured by the WHODAS 2.0 (mobility, self-care, getting along, life activities, participation subscales) as part of measuring broad functional effects. 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
Global functioning (IPF)
Lasso di tempo: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Change in global functioning will be measured by the Inventory of Psychosocial Functioning (IPF), as part of measuring broad functional effects. The IPF measures PTSD-related impairment in social and life responsibilities, such as romantic and family relationships, work, friendships and socializing, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale, with higher scores indicating greater functional impairment.
baseline, post (week 10), 3-month follow-up, 6-month follow-up
Day-to-day functioning
Lasso di tempo: baseline, post (week 10)
A composite score, Positive Activities for Cognitive Engagement (PACE), will be used to measure COGENT effects on day-to-day functioning. This composite score will be generated from results of ecological momentary assessment (EMA) surveys and ecological momentary cognitive testing (EMCT), which will be administered to participants via smartphone 3 times per day for the 7-day period directly after the baseline and post-treatment visits.
baseline, post (week 10)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

VA Office of Research and Development

Investigatori

  • Investigatore principale: Jessica A Bomyea, PhD, VA San Diego Healthcare System, San Diego, CA

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2027

Completamento primario (Stimato)

1 gennaio 2030

Completamento dello studio (Stimato)

31 marzo 2030

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RRD4-010-25W

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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