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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, approximately 5 or 6 weeks for reporting.

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 more

Other study objectives

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

General Anxiety Disorder 7 (GAD-7)

PHQ-9 (Patient Health Questionnaire-9)

+1 more

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03337113

Discomfort during stimulation session.

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met