search
Back to results

Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Neurobehavioral Intervention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety focused on measuring Computerized neurobehavioral intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • current anxiety or depression symptoms
  • internet access

Exclusion Criteria:

  • lifetime psychotic disorder, past-year substance dependence

Sites / Locations

  • Stanford University, Department of Psychiatry and Behavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Engaging computerized tasks

Neurobehavioral computerized tasks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2011
Last Updated
March 22, 2019
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01466751
Brief Title
Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Official Title
Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Computerized neurobehavioral intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Engaging computerized tasks
Arm Type
Active Comparator
Arm Description
Participants will log into a personalized website and engage in computerized tasks online.
Arm Title
Neurobehavioral computerized tasks
Arm Type
Experimental
Arm Description
Participants will log into a personalized website and engage in computerized tasks online.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Neurobehavioral Intervention
Intervention Description
Targeted, computerized interventions completed from the participants' own home on a computer.
Primary Outcome Measure Information:
Title
Reaction Time to Facial Affect Identification During Emotional Conflict
Description
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).
Time Frame
Baseline, 3-month
Title
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict
Description
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.
Time Frame
Baseline, 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: current anxiety or depression symptoms internet access Exclusion Criteria: lifetime psychotic disorder, past-year substance dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Fonzo, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University, Department of Psychiatry and Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits

We'll reach out to this number within 24 hrs