AnxietyNCT01466751

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

A study testing Computerized Neurobehavioral Intervention in people with Anxiety and Depression, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anxiety, Depression
What is being tested?: Computerized Neurobehavioral Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

current anxiety or depression symptoms
internet access

Who cannot join

lifetime psychotic disorder, past-year substance dependence

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University, Department of Psychiatry and Behavioral Sciences
Stanford, California, 94305

Other trials in United States

About this study

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.

Conditions: Anxiety, Depression
Being tested: Computerized Neurobehavioral Intervention
Keywords: Computerized neurobehavioral intervention
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01466751
Study group	Role	What they receive
Engaging computerized tasks	Active comparator	Participants will log into a personalized website and engage in computerized tasks online. Receives: Behavioral: Computerized Neurobehavioral Intervention
Neurobehavioral computerized tasks	Experimental	Participants will log into a personalized website and engage in computerized tasks online. Receives: Behavioral: Computerized Neurobehavioral Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Baseline, 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Dec 2013

First posted8 Nov 2011 (estimated)
Study startJan 2011
Primary completionJan 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01466751
Sponsor's protocol ID: IRB-19338
Status last verified: Mar 2019
First submitted: 3 Nov 2011
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
ClinicalTrials.gov ID: NCT01466751
Acronym / sponsor ID: IRB-19338
Conditions: Anxiety, Depression
Keywords: Computerized neurobehavioral intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Jan 2011
Primary completion: Jan 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 8 Nov 2011 (estimated)
Results: Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Engaging computerized tasks	Active comparator	Behavioral: Computerized Neurobehavioral InterventionParticipants will log into a personalized website and engage in computerized tasks online.
Neurobehavioral computerized tasks	Experimental	Behavioral: Computerized Neurobehavioral InterventionParticipants will log into a personalized website and engage in computerized tasks online.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

current anxiety or depression symptoms
internet access

Key exclusion criteria (1 listed)

lifetime psychotic disorder, past-year substance dependence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computerized Neurobehavioral InterventionTargeted, computerized interventions completed from the participants' own home on a computer.	Behavioural	Engaging computerized tasks, Neurobehavioral computerized tasks

Primary outcome

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).
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.

Results and safety

Results posted to the registry on 20 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neurobehavioral Computerized Tasks	14	13
Engaging Computerized Tasks	14	14

Primary outcome: Reaction Time to Facial Affect Identification During Emotional Conflict

Time frame: Baseline, 3-month. Mean (Standard Deviation). Unit: milliseconds

Measure	Engaging Computerized Tasks n = 12	Neurobehavioral Computerized Tasks n = 12
Baseline Congruent Fear	802.15 (155.14)	889.14 (135.65)
Baseline Incongruent Fear	848.79 (142.18)	937.97 (151.94)
Baseline Congruent Happy	764.08 (130.52)	868.45 (131.05)
Baseline Incongruent Happy	830.06 (142.29)	961.49 (134.32)
3 Month Congruent Fear	814.58 (158.56)	872.84 (178.04)
3 Month Incongruent Fear	863.80 (144.65)	909.89 (193.45)
3 Month Congruent Happy	796.54 (130.62)	824.36 (196.77)
3 Month Incongruent Happy	878.40 (175.54)	890.90 (196.22)

Engaging Computerized Tasks vs Neurobehavioral Computerized Tasks: Type III Tests of Fixed Effects: 8.687, p = 0.004, Mixed Models Analysis

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

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

Time frame: Baseline, 3 Months. Mean (Standard Deviation). Unit: Percentage of BOLD signal change

Measure	Neurobehavioral Computerized Tasks n = 14	Engaging Computerized Tasks n = 14
Baseline Left Amygdala Fear	0.21 (0.93)	0.16 (0.54)
Baseline Left Amygdala Happy	0.25 (1.05)	-0.29 (0.79)
Baseline Right Amygdala Fear	0.04 (1.24)	0.02 (0.60)
Baseline Right Amygdala Happy	-0.30 (0.86)	-0.23 (0.85)
3 Month Left Amygdala Fear	0.13 (0.85)	0.38 (0.79)
3 Month Left Amygdala Happy	-0.03 (0.76)	0.18 (1.02)
3 Month Right Amygdala Fear	0.05 (0.66)	0.21 (0.92)
3 Month Right Amygdala Happy	-0.10 (0.85)	0.05 (0.85)

Neurobehavioral Computerized Tasks vs Engaging Computerized Tasks: Type III Tests of Fixed Effects: 2.032, p = 0.156, Mixed Models Analysis

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engaging Computerized Tasks	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Neurobehavioral Computerized Tasks	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Greg Fonzo, PhD study director

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Neurobehavioral Intervention in people with Anxiety and Depression, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction Time to Facial Affect Identification During Emotional Conflict (time frame: Baseline, 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01466751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.