Posttraumatic Stress DisorderNCT07693686
Cognitive Training for Functioning in PTSD
A study testing COGENT (Cognitive ENhancement Training) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- COGENT (Cognitive ENhancement Training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of PTSD
- presence of subjective cognitive complaints
- fluent in English
- willing to attend assessment and treatment sessions
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Jessica A Bomyea, PhD, (858) 642-3720, jessica.bomyea@va.gov
Jessica A Bomyea, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- COGENT (Cognitive ENhancement Training), ST (Sham Training)
- Keywords
- Posttraumatic stress disorder, traumatic stress
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGENT (Cognitive ENhancement Training)Behavioural
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.
ST (Sham Training)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive ENhancement Training (COGENT) | Experimental | Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT). Receives: Behavioral: COGENT (Cognitive ENhancement Training) |
| Sham Training (ST) | Sham comparator | Participants will be Veterans assigned to the sham training comparator (ST), a non-training cognitive program matched for time and memory demands. Receives: Behavioral: ST (Sham Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Secondary outcomes (1)
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.
Measured: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jessica A Bomyea, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693686
- Sponsor's protocol ID
- RRD4-010-25W
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Address Functioning and Symptoms in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07693686
- Acronym / sponsor ID
- RRD4-010-25W
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic stress disorder, traumatic stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive ENhancement Training (COGENT) | Experimental | Behavioral: COGENT (Cognitive ENhancement Training)Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT). |
| Sham Training (ST) | Sham comparator | Behavioral: ST (Sham Training)Participants will be Veterans assigned to the sham training comparator (ST), a non-training cognitive program matched for time and memory demands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of PTSD
- presence of subjective cognitive complaints
- fluent in English
- willing to attend assessment and treatment sessions
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive ENhancement Training (COGENT) |
| 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). | Behavioural | Sham Training (ST) |
Primary outcome
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain
Time frame: 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.
1 secondary outcome
Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale
Time frame: baseline, post (week 10), 3-month follow-up, 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica A Bomyea, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGENT (Cognitive ENhancement Training) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica A Bomyea, PhD ((858) 642-3720, jessica.bomyea@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain (time frame: baseline, post (week 10), 3-month follow-up, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.