Cognitive Training for Functioning in PTSD

NCT07693686 | Not Yet Recruiting

• 1 other identifier: RRD4-010-25W
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic stress disorder; traumatic stress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale

  baseline, post (week 10), 3-month follow-up, 6-month follow-up

Other Outcomes (8)

• Baseline neuropsychological performance

  baseline, post (week 10)

• Anxiety symptoms

  baseline, post (week 10), 3-month follow-up, 6-month follow-up

• Depression symptoms

  baseline, post (week 10), 3-month follow-up, 6-month follow-up

Study Arms (2)

Cognitive ENhancement Training (COGENT)

EXPERIMENTAL

Participants will be Veterans assigned to the active cognitive training program, Cognitive ENhancement Training (COGENT).

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.

Behavioral: ST (Sham Training)

Interventions

COGENT (Cognitive ENhancement Training) BEHAVIORAL

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.

Cognitive ENhancement Training (COGENT)

ST (Sham Training) BEHAVIORAL

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).

Sham Training (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jessica A Bomyea, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica A Bomyea, PhD

CONTACT

(858) 642-3720; jessica.bomyea@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)