NCT01466751

Brief Summary

The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

June 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

November 3, 2011

Results QC Date

July 15, 2015

Last Update Submit

March 22, 2019

Conditions

AnxietyDepression

Keywords

Computerized neurobehavioral intervention

Outcome Measures

Primary Outcomes (2)

  • Reaction Time to Facial Affect Identification During Emotional Conflict

    A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word ("FEAR" or "HAPPY"), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent).

    Baseline, 3-month

  • Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict

    The degree of differential BOLD signal change (T2\*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word "FEAR" or "HAPPY" was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months.

    Baseline, 3 Months

Study Arms (2)

Engaging 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 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 anxiety or depression symptoms
  • 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, 94305, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Amit Etkin
Organization
Stanford University
amitetkin@stanford.edu
650-725-5736

Study Officials

  • Greg Fonzo, PhD

    Stanford University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

November 3, 2011

First Posted

November 8, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

December 1, 2013

Last Updated

June 20, 2019

Results First Posted

June 20, 2019

Record last verified: 2019-03

Locations

US(1)