Cognitive Control Training for Extinction in PTSD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fluent in English

Meet current DSM-5 criteria for Posttraumatic Stress Disorder

Are willing to attend 8 total remote sessions of working memory training over course of four weeks

Are willing to attend MRI scans pre and post working memory training

Disqualifiers

A lifetime history of psychotic disorders, lifetime history of bipolar disorder

Past-year severe substance use and severe alcohol use disorder. Mild-to-moderate alcohol use disorder will be allowed to enhance generalizability in our sample due to the high comorbidity of alcohol use and PTSD

History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)

Acute suicidality requiring immediate clinical intervention

Trial design

Design model

Parallel

Treatments tested in this trial

  • Working Memory Training

    Behavioral

    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.

  • Sham Training

    Other 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 groups

120 Participants
are divided into 2 treatment groups
Group A: Working Memory TrainingExperimental treatment 1 intervention
Group B: Sham TrainingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Behavioral Threat Expectancy Ratings During Extinction Performance

Threat Expectancy Ratings. Behavioral ratings will be collected during the extinction learning task. Responses will be on scale of 1- 4. High scores reflect greater threat expectancy. It is expected that the working memory training group (WMT) will have lower threat expectancy ratings during extinction learning than the Sham group.

Time frame
Baseline, Approximately 5 or 6 weeks
2

Extinction Electrodermal Activity Response

Electrodermal Activity Response. Responses are measured in microsiemens and time-locked to the CS+ trials during extinction learning. It is expected that the working memory training group (WMT) will have lower electrodermal activity responses during extinction learning than the Sham group.

Time frame
Baseline, Approximately 5 or 6 weeks
3

Extinction Blood Oxygen Level Dependent (BOLD) Response

Functional Magnetic Resonance Imaging (fMRI) will be used to measure Blood Oxygen Level Dependent (BOLD) Response during the Extinction task. BOLD response during the extinction task conditions are measured using % signal change from baseline BOLD activity with higher scores indicating greater activation. It is expected that the working memory training group (WMT) will have greater changes in BOLD responses during extinction learning than the Sham group.

Time frame
Baseline, Approximately 5 or 6 weeks

Secondary outcomes

1

Working Memory Task Blood Oxygen Level Dependent (BOLD) Response

Functional Magnetic Resonance Imaging (fMRI) will be used to measure Blood Oxygen Level Dependent (BOLD) Response during a working memory capacity task while undergoing functional MRI. BOLD response to the task conditions is measured using % signal change with higher scores indicating greater activation.

Time frame
Baseline, Approximately 5 or 6 weeks
2

Working memory capacity change detection task

This behavioral task measures the number of visual items maintained in working memory and is a measure of working memory capacity. This task will use simple geometric shapes as stimuli. Scores are measured using percent accuracy (o - 100%) and a measure of working memory capacity (K-score range: 0 - 6 in this task). High scores indicate greater accuracy and working memory capacity.

Time frame
Baseline, Approximately 5 or 6 weeks
3

Affective working memory task

An affective working memory task. A behavioral task, the affective working memory task measures working memory capacity - how many stimuli are stored in working memory) and include conditions with an emotional distractors. Scores are measured using percent accuracy (range: 0-100%) and a measure of working memory capacity (K-score range: 0 - 2 in this task). High scores indicate greater accuracy and working memory capacity. Reaction time (in milliseconds) will also be collected. High Reaction time indicates slower or more impaired working memory ability.

Time frame
Baseline, Approximately 5 or 6 weeks
4

Flanker Task

This behavioral task measures cognitive and motor inhibition. Stimuli consist of arrows presented at the center of a computer screen. Reaction Time (in milliseconds) for button presses will be the primary variable. High scores indicate slower reaction time to make the required behavioral response. The investigators will also measure accuracy, with high scores indicating higher accuracy and will be scored as percent correct (range: 0-100%)

Time frame
Baseline, Approximately 5 or 6 weeks

Other outcomes

1

PTSD Checklist for DSM-5 (PCL-5)

Self-reported Posttraumatic Stress Disorder (PTSD) symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5).The total score ranges from 0-80, with higher scores indicating higher severity.

Time frame
Baseline, Approximately 5 or 6 weeks
2

PHQ-9 (Patient Health Questionnaire-9)

Depression symptoms will be measured using the PHQ-9 (Patient Health Questionnaire-9). Scores range from 0 - 27. Higher scores indicating higher depression symptoms and severity.

Time frame
Baseline, Approximately 5 or 6 weeks
3

General Anxiety Disorder 7 (GAD-7)

Anxiety symptoms will be measured with the General Anxiety Disorder 7 (GAD-7). The total score ranges from 0-21. High scores indicate higher levels of anxiety symptoms.

Time frame
Baseline, Approximately 5 or 6 weeks
4

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

Clinician-rated Posttraumatic Stress Disorder (PTSD) symptoms and PTSD diagnostic status will be measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Symptom severity ranges from 0 - 80. High scores indicate greater PTSD symptom severity.

Time frame
Baseline, Approximately 5 or 6 weeks

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