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Cognitive Training for Functioning in PTSD

14 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

176

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Contato:
        • Investigador principal:
          • Jessica A Bomyea, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cognitive ENhancement Training (COGENT)
Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).
Comportamental: 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.
Comparador Falso: 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.
Comportamental: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Baseline neuropsychological performance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Jessica A Bomyea, PhD, VA San Diego Healthcare System, San Diego, CA

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2027

Conclusão Primária (Estimado)

1 de janeiro de 2030

Conclusão do estudo (Estimado)

31 de março de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de julho de 2026

Primeira postagem (Real)

9 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RRD4-010-25W

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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