Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD

August 14, 2018 updated by: Amit Etkin, Stanford University

Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD - A Nationwide, Online Study

The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in individuals with PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin Lab at Stanford University in California, but participants from the entire US are welcome to participate as the study is delivered online.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States
        • Stanford University, Department of Psychiatry and Behavioral Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • current PTSD
  • internet access

Exclusion Criteria:

  • lifetime psychotic disorder,
  • past-year substance dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Engaging in Computerized tasks
Participants will log into a personalized website and engage in computerized tasks online.
Behavioral: Computerized Neurobehavioral Intervention
Targeted, computerized interventions completed from the participants' own home on a computer.
Experimental: Neurobehavioral computerized tasks
Participants will log into a personalized website and engage in computerized tasks online.
Behavioral: Computerized Neurobehavioral Intervention
Targeted, computerized interventions completed from the participants' own home on a computer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WebNeuro Computerized Cognitive and Affective Assessment Battery
Time Frame: Baseline and 3-month

Age and gender-normed Z scores for the following measures:

Sustained attention accuracy, Sustained attention lapses, Sustained attention false alarms, Working memory capacity, Visual scanning speed, Inhibition executive control, Processing speed, Maze completion executive control accuracy, Maze completion executive control speed, Immediate verbal memory, Delayed verbal memory, Inhibitory motor control accuracy, Inhibitory motor control lapses, Facial affect identification accuracy (happy, fearful, angry, sad, and disgusted), Facial affect identification speed (happy, angry, fearful, sad, or disgusted), Facial affect identity recognition accuracy (happy, angry, sad, fearful, or disgusted), Facial affect identity recognition speed (happy, sad, angry, fearful, or disgusted), Emotional conflict reaction time slowdown, Regulation of emotional conflict reaction time slowdown
Baseline and 3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-assessed PTSD symptoms
Time Frame: Baseline and 3-month
Total and symptom sub scale scores from the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Baseline and 3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-24890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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