NCT01694316

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

4.3 years

First QC Date

September 24, 2012

Last Update Submit

August 14, 2018

Conditions

AnxietyDepression

Keywords

Computerized neurobehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • WebNeuro Computerized Cognitive and Affective Assessment Battery

    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 Outcomes (1)

  • Clinician-assessed PTSD symptoms

    Baseline and 3-month

Study Arms (2)

Engaging in Computerized tasks

ACTIVE COMPARATOR

Participants will log into a personalized website and engage in computerized tasks online.

Behavioral: Computerized Neurobehavioral Intervention

Neurobehavioral computerized tasks

EXPERIMENTAL

Participants will log into a personalized website and engage in computerized tasks online.

Behavioral: Computerized Neurobehavioral Intervention

Interventions

Computerized Neurobehavioral InterventionBEHAVIORAL

Targeted, computerized interventions completed from the participants' own home on a computer.

Engaging in Computerized tasksNeurobehavioral computerized tasks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current PTSD
  • internet access

You may not qualify if:

  • lifetime psychotic disorder,
  • past-year substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, United States

Location

Related Publications (1)

  • Fonzo GA, Fine NB, Wright RN, Achituv M, Zaiko YV, Merin O, Shalev AY, Etkin A. Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. J Psychiatr Res. 2019 Aug;115:82-89. doi: 10.1016/j.jpsychires.2019.05.007. Epub 2019 May 8.

    PMID: 31125916DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)