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N/A N=81 Randomized Triple-blind Treatment

Cognitive Training for PTSD

Posttraumatic Stress Disorder

Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Clinician Administered PTSD Scale - Reexperiencing — 2.6; 2.96 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
COGENT COGNITIVE TRAINING (Behavioral); Non training computer condition (Behavioral)
Age
Adult · 21+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinician Administered PTSD Scale - Reexperiencing
2.6; 2.96
PRIMARY
Delis-Kaplan Executive Functioning System
-.36; -1.33
SECONDARY
Reading Span fMRI Task
.47; 2.65
SECONDARY
Emotion Regulation fMRI Task
-.01; .06
SECONDARY
Clinician Administered PTSD Scale Diagnosis
21; 16

Summary

Posttraumatic stress disorder (PTSD) is a chronic, disabling condition that occurs in a subgroup of individuals after experiencing traumatic stress, and is common in Veterans seeking mental health treatment at the VA. Although evidence-based psychosocial treatments exist for PTSD, a substantial portion of individuals do not fully respond to treatment. Thus, there is a clear need to continue researching novel interventions for PTSD in Veterans. Recently, new interventions for mental health disorders have utilized computerized cognitive training techniques in order to improve the functioning of cognitive systems and reduce symptoms. This type of intervention, often referred to as neurotherapeutics, may hold promise for PTSD as a method for ameliorating symptoms and improving cognition. Individuals with PTSD demonstrate difficulties with cognitive control functions, which appear to be causally implicated in symptoms of the disorder (e.g., intrusive trauma-related memories). To date the efficacy of neurotherapeutics for PTSD has been understudied in Veterans. The current proposal aims to bridge research on basic neurocognitive mechanisms of PTSD with intervention research by conducting a randomized controlled trial (RCT) of a cognitive control training program in 80 Veterans with PTSD. Veterans will complete computer-based training exercises designed to specifically target and improve aspects of cognitive control. Veterans will complete the program twice per week for eight weeks. Symptoms will be assessed before and after treatment, as well as at a two month follow up time point. The primary goal of the study is to examine the effect of the intervention on PTSD symptoms and cognitive deficits. Evaluating symptom change as a result of the intervention will provide critical data regarding the utility of this program as a PTSD treatment. If effective, this training program could serve as alternative treatment option for Veterans with PTSD, and could be translated into an easily transportable intervention for dissemination (e.g., through web-based platforms). A secondary goal is to use functional magnetic resonance imaging (fMRI) to better understand the mechanisms by which cognitive training culminates in symptom reduction. If training cognitive control with neurotherapeutics directly enhances functioning of specific neural substrates as hypothesized, improvements in affective processes relying on shared neural regions would also be predicted. Modifying functioning in these substrates with training may thus reduce symptoms by improving neural functioning while processing and managing trauma-related affect and information. Neural systems used for cognitive control targeted in the training described (e.g., dorsolateral prefrontal cortex [dlPFC]) are also recruited when individuals mentally manipulate emotional information, such as when individuals use reappraisal to change the way that they think about negative emotional situations or content. In this study, Veterans will complete a neutral cognitive control task and a reappraisal task while undergoing fMRI before and after completing the training treatment. This will be the first study to evaluate neurobiological mechanisms of this type of training in PTSD, which is a fundamental next step for understanding how to improve the training program and who may be best served by completing it.

Eligibility Criteria

Inclusion Criteria

Eligible participants will be Veterans who:

  • meet primary, current DSM-5 criteria for Posttraumatic Stress Disorder
  • are literate in English
  • intend to remain in the San Diego geographical area for the duration of the study
  • are willing to attend assessment and treatment sessions

Exclusion Criteria

  • for the MRI portion, inability to safely complete fMRI session - unsafe metal in body, e.g.:
  • devices such as pacemakers
  • metal fragments in the skin like shrapnel
  • history of metal work or welding
  • history of eye surgery or washes because of metal
  • aortic/aneurysm clips
  • prosthesis
  • bypass surgery/coronary artery clips
  • hearing aids
  • heart-valve replacement
  • intrauterine devices with metal
  • shunts
  • electrodes
  • metal plates/pins/screws
  • neuro or bio-stimulators
  • older tattoos with metal ink
  • piercings the subject is unable or unwilling to remove
  • uncorrectable vision problems
  • claustrophobia
  • inability to lie still on the back for approximately one hour
  • inability to safely fit within the dimensions of the fMRI machine
  • prior neurosurgery
  • pregnancy or current breastfeeding (within 3 months)
  • current IV drug use due to potential cerebrovascular effects
  • or any other conditions that are deemed by Keck Imaging Center staff to contraindicated to safely complete the fMRI scanning
  • a lifetime history of psychotic disorders
  • lifetime history of bipolar disorder
  • severe substance use disorder within the last year
  • other psychiatric conditions that may adversely impact cognition and/or are deemed to require other primary psychological intervention
  • history of any neurological disorder that might be associated with cognitive dysfunction, e.g.:
  • cerebrovascular accident
  • intracranial surgery
  • aneurysm
  • seizure disorder
  • acute suicidality (defined as intent, plan, and/or attempt for severe self-harm within the past 3 months)
  • or current circumstances that present a direct threat to the individual and require more imminent intervention, e.g.:
  • current domestic abuse
  • individuals planning to begin medication changes within the time-frame of the study
  • individuals currently undergoing evidence-based psychotherapy for PTSD
  • individuals planning non-PTSD related psychosocial therapy change within the pre- to post-treatment time frame of the study
  • those with life-threatening or acutely unstable medical conditions
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03316196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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