Emotional Working Memory Training for Veterans With PTSD Symptoms

NCT02766296 | Completed

• 1 other identifier: 5134-03
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; trauma; working memory; working memory training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

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

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

Study Arms (2)

Active Emotional Working Memory Training

EXPERIMENTAL

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

Control Working Memory Training

PLACEBO COMPARATOR

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

Interventions

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.

Active Emotional Working Memory Training

Control Working Memory Training BEHAVIORAL

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

Control Working Memory Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milwaukee VA Medical Center: lead

Study Sites (1)

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, 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

Study Officials

• Sadie Larsen, Ph.D.

  Clement J. Zablocki VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

US (1)