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Behavioural Intervention
Working Memory Training for PTSD
N/A
Recruiting
Led By Daniel M Stout, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet current DSM-5 criteria for Posttraumatic Stress Disorder
Be older than 18 years old
Must not have
History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, approximately 5 or 6 weeks
Summary
This trial aims to see if a training program that improves working memory can also improve the ability to overcome fear in Veterans with PTSD. The study will use advanced analyses to understand how working memory and fear extinction
Who is the study for?
This trial is for Veterans with PTSD who can participate in a program designed to improve their memory and ability to focus. It's not suitable for individuals who might have other conditions that could interfere with the training or its assessment.
What is being tested?
The study is testing a working memory training (WMT) program against sham training to see if it helps Veterans with PTSD learn how to better manage fear responses. The effectiveness of WMT will be measured through changes in brain function and PTSD symptoms.
What are the potential side effects?
Since this trial involves cognitive exercises, there may not be physical side effects like those seen with medication. Participants may experience mental fatigue or frustration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD according to the DSM-5.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of brain-related health issues that could affect my thinking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, approximately 5 or 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, approximately 5 or 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Behavioral Threat Expectancy Ratings During Extinction Performance
Extinction Blood Oxygen Level Dependent (BOLD) Response
Extinction Electrodermal Activity Response
Secondary study objectives
Affective stop signal task
Affective working memory task
Flanker Task
+2 moreOther study objectives
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
General Anxiety Disorder 7 (GAD-7)
PHQ-9 (Patient Health Questionnaire-9)
+1 moreSide effects data
From 2021 Phase 2 trial • 50 Patients • NCT033371138%
Discomfort during stimulation session.
100%
80%
60%
40%
20%
0%
Study treatment Arm
WMT + rTMS
Sham WMT + rTMS
WMT + Sham rTMS
Sham WMT + Sham rTMS
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Working Memory TrainingExperimental Treatment1 Intervention
Computer-administered working memory training program. WMT is a modified working memory capacity task designed to train working memory functioning. WMT is designed to contain high interference across trials and is adaptive to performance. As participants improve working memory, the task becomes more difficult.
Group II: Sham TrainingPlacebo Group1 Intervention
The Sham condition requires participants to complete a similar computer task for the same length of time. The Sham Training is a modified working memory capacity task designed to place less demands on working memory.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Working Memory Training
2013
Completed Phase 2
~950
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,746 Total Patients Enrolled
Daniel M Stout, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA