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Completed

NCT Number: NCT02766296

Emotional Working Memory Training for Veterans With PTSD Symptoms

PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. Participants will be randomly assigned to one of the two computerized training programs. At baseline, post-training, and 1-month follow-up, participants will be assessed with respect to their emotional symptoms and working memory-related cognitive performance. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

About this study

PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The long-term objective is to develop an effective cognitive treatment program that can reduce such intrusive cognitions observed among individuals who have been exposed to a significant trauma. The specific objective is to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. eWMT is designed to improve the individual's ability to stay focused on the target and filter out irrelevant information from their working memory, which is expected to improve trauma-related emotional symptoms via the improvement of working memory functioning.

Individuals who display elevated trauma symptoms will be randomly assigned to one of two eWMT conditions: (a) adjustable n-back training (i.e., potent working memory training program), and (b) fixed 1-back training (i.e., training that delivers a limited dose). Participants will be blinded to ensure objective assessment of the intervention effects. Before and after the eWMT intervention, all participants will undergo an assessment session that aims to assess each individual's emotional symptoms and working memory-related cognitive performance. Further, following completion of procedure, participants will be invited for a follow-up assessment to assess the long-term effect of training.

The eWMT intervention will be delivered via Internet. Thus, the current intervention is a home-based Internet intervention, which provides an important context for testing and developing a cost-efficient, accessible, and effective intervention program for many individuals suffering from exposure to traumas. Each training session will take about 20 minutes, and all participants in both conditions will receive a total of 15 training sessions. Participants will be guided to complete an average of 3 training sessions every week for a total duration of approximately 5 weeks.

Investigators hypothesize that individuals who undergo the active eWMT will display a greater improvement in overall working memory performance and a greater reduction in trauma-related symptoms, compared to individuals who undergo the less effective control training program. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program that can reach out to many individuals who suffer from exposure to traumas.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluently speaks English
  • The PTSD Checklist (PCL-5) total score >= 38

Exclusion criteria

  • No access to a private computer with high-speed Internet that can be used privately.
  • Elevated suicidality
  • History of psychotic disorders (e.g., schizophrenia)
  • Severe substance use disorder (as per DSM-5 criteria)
  • History of severe brain injury or organic mental syndrome

Treatment and study plan

Active Emotional Working Memory Training

Behavioral

This training regimen has adapted the existing n-back paradigm, which has been widely used in the field. Training requires participants to shift between visual and auditory information while continually updating their working memory.

Control Working Memory Training

Behavioral

This training utilized a fixed dual 1-back training paradigm.

Primary outcomes

  1. Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up

    Time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

    PTSD Checklist (PCL-5)

Secondary outcomes

  1. Change in working memory performance from baseline to post-training and 1-month follow-up

    Time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

    Automated Complex Span Tasks (Oswald et al., 2014). This is a well-validated computerized measure of working memory capacity, including three sub-domains: (1) Operation span, (2) Reading span, and (3) Symmetry span.

Other outcomes

  1. Change in physiological reactivity to the description of one's own traumatic experience from baseline to post-training and 1-month follow-up

    Time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

    Each participant will be guided to listen to the audiotaped version of his/her own traumatic experience while trying to recollect the event as vividly as possible. Raw ECG signals will be recorded before, during, and after the recollection to measure changes in heart rate variability as an index for emotional regulation and physiological reactivity.

Sponsors and collaborators

Lead sponsor

Milwaukee VA Medical Center

Fed

Registry information

Official study title

Emotional Working Memory Training for Veterans With Elevated Trauma-related Symptoms

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 9, 2016
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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