Emotional Working Memory Training for Veterans With PTSD Symptoms

June 19, 2018 updated by: Sadie Larsen, Milwaukee VA Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Clement J. Zablocki VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Emotional Working Memory Training
Each participant will receive 15 sessions (each lasting 20 minutes) over a 5 week. This will be Internet-based cognitive training based on the adaptive dual n-back paradigm.
Behavioral: Active Emotional Working Memory Training
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.
Placebo Comparator: Control Working Memory Training
Participants in this condition will receive 15 sessions (each lasting 20 minutes) over a 5-week period. This will also be home-based training over the Internet. This training will be based on a fixed 1-back training program.
Behavioral: Control Working Memory Training
This training utilized a fixed dual 1-back training paradigm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milwaukee VA Medical Center

Investigators

  • Principal Investigator: Sadie Larsen, Ph.D., Clement J. Zablocki VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 2, 2018

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5134-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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