Emotional Working Memory Training for Veterans With PTSD Symptoms

NCT ID: NCT02766296

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-05-02

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Emotional Working Memory Training

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Control Working Memory Training

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Control Working Memory Training

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milwaukee VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Sadie Larsen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadie Larsen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clement J. Zablocki VA Medical Center

Locations

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

5134-03

Identifier Type: -

Identifier Source: org_study_id