Emotional Working Memory Training for Veterans With PTSD Symptoms

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766296
• Other study ID #: 5134-03
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2, 2018

Study information

• Verified date: June 2018
• Source: Milwaukee VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.
• Control Working Memory Training
This training utilized a fixed dual 1-back training paradigm.

Locations

Country	Name	City	State
United States	Clement J. Zablocki VA Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Milwaukee VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physiological reactivity to the description of one's own traumatic experience from baseline to post-training and 1-month follow-up	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)
Primary	Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up	PTSD Checklist (PCL-5)	At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Secondary	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.	At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)