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Cognitive Training for PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316196
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: COGENT COGNITIVE TRAINING Behavioral: Non training computer condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Training as a Novel Neuroscience-based Treatment for PTSD
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : July 28, 2023
Estimated Study Completion Date : September 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COGENT
Participants will be Veterans assigned to the active cognitive training (see below for details).
Behavioral: COGENT COGNITIVE TRAINING
Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources

Sham Comparator: Non-Training
Participants will be Veterans assigned to a non-training cognitive program matched for time and memory demands (see below for details).
Behavioral: Non training computer condition
The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale - reexperiencing [ Time Frame: Pre to Post Intervention (baseline to week 8) ]
    This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.

  2. Delis-Kaplan Executive Functioning System [ Time Frame: Pre to Post Intervention (baseline to week 8) ]
    The Delis-Kaplan Executive Functioning System (DKEFS). This neuropsychological battery is designed to assess cognitive abilities in the executive functioning domain. Two relevant subtests, the Trail Making test and Color Word Interference Test, will be used. Total scores are calculated using a normed t score ranging from 0 to 100 with higher scores indicating better performance; change over time will be evaluated.


Secondary Outcome Measures :
  1. Reading Span fMRI task (baseline to week 8) [ Time Frame: Pre to Post Intervention ]
    The Reading Span task is a working memory capacity assessment participants complete while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation; change over time will be evaluated.

  2. Emotion Regulation fMRI task (baseline to week 8) [ Time Frame: Pre to Post Intervention ]
    The Emotion Regulation task is an assessment of how well participants can modulate their emotions in response to viewing images while undergoing functional MRI. Neural activation to task condition is measured using % signal change (0-100) with higher scores indicating greater activation; change over time will be evaluated.

  3. Clinician Administered PTSD Scale diagnosis [ Time Frame: Pre to Post Intervention (baseline to week 8) ]
    This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Diagnostic status yes/no from the measure will be included as a secondary outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316196


Contacts
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Contact: Jessica A Bomyea, PhD (858) 642-3720 jessica.bomyea@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Jessica A Bomyea, PhD    858-642-3720    jessica.bomyea@va.gov   
Principal Investigator: Jessica A Bomyea, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jessica A Bomyea, PhD VA San Diego Healthcare System, San Diego, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03316196    
Other Study ID Numbers: MHBB-023-17S
CX001600-01A1 ( Other Grant/Funding Number: VA )
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
trauma
PTSD
cognition
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders