Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic stress disorder, traumatic stress
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.
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.
Interventions
BEHAVIORALCOGENT (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.
BEHAVIORALST (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).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognitive domain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale-5 (CAPS-5) - reexperiencing scale | 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. |
Countries
United States
Contacts
CONTACTJessica A Bomyea, PhD
PRINCIPAL_INVESTIGATORJessica A Bomyea, PhD
VA San Diego Healthcare System, San Diego, CA
Outcome results
None listed