Cognitive Training for Functioning in PTSD

ConditionPosttraumatic Stress Disorder

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of PTSD

presence of subjective cognitive complaints

fluent in English

willing to attend assessment and treatment sessions

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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).

Treatment groups

176 Participants

are divided into 2 treatment groups

Group A: Cognitive ENhancement Training (COGENT)Experimental treatment 1 intervention

Group B: Sham Training (ST)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Other outcomes

Baseline neuropsychological performance

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.

Time frame

baseline, post (week 10)

Anxiety symptoms

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.

Time frame

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

Depression symptoms

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.

Time frame

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

Suicide risk level

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

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