Trial Outcomes & Findings for Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits (NCT NCT01466751)

Last Updated: 2019-06-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Baseline, 3-month

Results posted on

2019-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Neurobehavioral Computerized Tasks Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.	Engaging Computerized Tasks Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.
Overall Study STARTED	14	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engaging Computerized Tasks n=14 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.	Neurobehavioral Computerized Tasks n=14 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.	Total n=28 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 10 • n=93 Participants	36 years STANDARD_DEVIATION 12 • n=4 Participants	35.5 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	10 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	14 participants n=4 Participants	28 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 3-month

Population: Participants who complete the protocol were included in the analysis.

Outcome measures

Outcome measures
Measure	Engaging Computerized Tasks n=12 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.	Neurobehavioral Computerized Tasks n=12 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.
Reaction Time to Facial Affect Identification During Emotional Conflict 3 Month Congruent Fear	814.58 milliseconds Standard Deviation 158.56	872.84 milliseconds Standard Deviation 178.04
Reaction Time to Facial Affect Identification During Emotional Conflict 3 Month Incongruent Fear	863.80 milliseconds Standard Deviation 144.65	909.89 milliseconds Standard Deviation 193.45
Reaction Time to Facial Affect Identification During Emotional Conflict 3 Month Congruent Happy	796.54 milliseconds Standard Deviation 130.62	824.36 milliseconds Standard Deviation 196.77
Reaction Time to Facial Affect Identification During Emotional Conflict 3 Month Incongruent Happy	878.40 milliseconds Standard Deviation 175.54	890.90 milliseconds Standard Deviation 196.22
Reaction Time to Facial Affect Identification During Emotional Conflict Baseline Congruent Fear	802.15 milliseconds Standard Deviation 155.14	889.14 milliseconds Standard Deviation 135.65
Reaction Time to Facial Affect Identification During Emotional Conflict Baseline Incongruent Fear	848.79 milliseconds Standard Deviation 142.18	937.97 milliseconds Standard Deviation 151.94
Reaction Time to Facial Affect Identification During Emotional Conflict Baseline Congruent Happy	764.08 milliseconds Standard Deviation 130.52	868.45 milliseconds Standard Deviation 131.05
Reaction Time to Facial Affect Identification During Emotional Conflict Baseline Incongruent Happy	830.06 milliseconds Standard Deviation 142.29	961.49 milliseconds Standard Deviation 134.32

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Engaging Computerized Tasks n=14 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.	Neurobehavioral Computerized Tasks n=14 Participants Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer.
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict Baseline Left Amygdala Fear	0.21 Percentage of BOLD signal change Standard Deviation 0.93	0.16 Percentage of BOLD signal change Standard Deviation 0.54
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict Baseline Left Amygdala Happy	0.25 Percentage of BOLD signal change Standard Deviation 1.05	-0.29 Percentage of BOLD signal change Standard Deviation 0.79
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict Baseline Right Amygdala Fear	0.04 Percentage of BOLD signal change Standard Deviation 1.24	0.02 Percentage of BOLD signal change Standard Deviation 0.60
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict Baseline Right Amygdala Happy	-0.30 Percentage of BOLD signal change Standard Deviation 0.86	-0.23 Percentage of BOLD signal change Standard Deviation 0.85
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict 3 Month Left Amygdala Fear	0.13 Percentage of BOLD signal change Standard Deviation 0.85	0.38 Percentage of BOLD signal change Standard Deviation 0.79
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict 3 Month Left Amygdala Happy	-0.03 Percentage of BOLD signal change Standard Deviation 0.76	0.18 Percentage of BOLD signal change Standard Deviation 1.02
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict 3 Month Right Amygdala Fear	0.05 Percentage of BOLD signal change Standard Deviation 0.66	0.21 Percentage of BOLD signal change Standard Deviation 0.92
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict 3 Month Right Amygdala Happy	-0.10 Percentage of BOLD signal change Standard Deviation 0.85	0.05 Percentage of BOLD signal change Standard Deviation 0.85

Adverse Events

Engaging Computerized Tasks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neurobehavioral Computerized Tasks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amit Etkin

Stanford University

Phone: 650-725-5736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place