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Cognitive Training for Functioning in PTSD

14 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

176

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Contact:
        • Hoofdonderzoeker:
          • Jessica A Bomyea, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cognitive ENhancement Training (COGENT)
Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).
Gedragsmatig: 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.
Sham-vergelijker: 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.
Gedragsmatig: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Baseline neuropsychological performance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2027

Primaire voltooiing (Geschat)

1 januari 2030

Studie voltooiing (Geschat)

31 maart 2030

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RRD4-010-25W

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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