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OpenTrials
Completed

NCT Number: NCT01466751

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • current anxiety or depression symptoms
  • internet access

Exclusion criteria

  • lifetime psychotic disorder, past-year substance dependence

Treatment and study plan

Computerized neurobehavioral intervention

Behavioral

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

Primary outcomes

  1. Reaction Time to Facial Affect Identification During Emotional Conflict

    Time frame: Baseline, 3-month

    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).

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

    Time frame: Baseline, 3 Months

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2011
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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