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Emotional Working Memory Training for Veterans With PTSD Symptoms

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Emotional Working Memory Training
Control Working Memory Training
Sponsored by
Milwaukee VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, trauma, working memory, working memory training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clement J. Zablocki VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Emotional Working Memory Training

Control Working Memory Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up
PTSD Checklist (PCL-5)

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2016
Last Updated
June 19, 2018
Sponsor
Milwaukee VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02766296
Brief Title
Emotional Working Memory Training for Veterans With PTSD Symptoms
Official Title
Emotional Working Memory Training for Veterans With Elevated Trauma-related Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milwaukee VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, trauma, working memory, working memory training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Emotional Working Memory Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Working Memory Training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Emotional Working Memory Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Working Memory Training
Intervention Description
This training utilized a fixed dual 1-back training paradigm.
Primary Outcome Measure Information:
Title
Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up
Description
PTSD Checklist (PCL-5)
Time Frame
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Secondary Outcome Measure Information:
Title
Change in working memory performance from baseline to post-training and 1-month follow-up
Description
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.
Time Frame
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Other Pre-specified Outcome Measures:
Title
Change in physiological reactivity to the description of one's own traumatic experience from baseline to post-training and 1-month follow-up
Description
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.
Time Frame
At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadie Larsen, Ph.D.
Organizational Affiliation
Clement J. Zablocki VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clement J. Zablocki VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

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Emotional Working Memory Training for Veterans With PTSD Symptoms

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