Clinical trial NCT02766296: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
trauma
working memory
working memory training
Lead sponsor: Milwaukee VA Medical Center
Sponsor class: FED
First posted: 2016-05-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up
timeFrame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Secondary outcomes:
measure: Change in working memory performance from baseline to post-training and 1-month follow-up
timeFrame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Other outcomes:
measure: Change in physiological reactivity to the description of one's own traumatic experience from baseline to post-training and 1-month follow-up
timeFrame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Locations:
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center
state: Wisconsin
Study officials:
affiliation: Clement J. Zablocki VA Medical Center
name: Sadie Larsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: