Cognitive Training for PTSD

NCT03316196 | Completed Results

• 2 other identifiers: MHBB-023-17SCX001600-01A1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

trauma; PTSD; cognition

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale - Reexperiencing

  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.

  Pre to Post Intervention (baseline to week 8)

• Delis-Kaplan Executive Functioning System

  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.

  Pre to Post Intervention (baseline to week 8)

Secondary Outcomes (3)

• Reading Span fMRI Task

  Pre to Post Intervention (baseline to week 8)

• Emotion Regulation fMRI Task

  Pre to Post Intervention (baseline to week 8)

• Clinician Administered PTSD Scale Diagnosis

  Pre to Post Intervention (baseline to week 8)

Study Arms (2)

COGENT

EXPERIMENTAL

Participants will be Veterans assigned to the active cognitive training (see below for details).

Behavioral: COGENT COGNITIVE TRAINING

Non-Training

SHAM COMPARATOR

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

Interventions

COGENT COGNITIVE TRAINING BEHAVIORAL

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

COGENT

Non training computer condition BEHAVIORAL

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.

Non-Training

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jessica Bomyea
• Organization: VA San Diego Healthcare System

jessica.bomyea@va.gov

8585528585

Study Officials

• Jessica A Bomyea, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Two arm randomized controlled trial

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 20, 2017
• Study Start: June 13, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)