HealthyNCT01694303
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
A study testing Computerized Neurobehavioral Intervention in people with Healthy, run by Stanford University at 1 site in United States.
Trial summary
The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
About this study
The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.
- Conditions
- Healthy
- Being tested
- Computerized Neurobehavioral Intervention
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 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.
Emotion-regulation - behavioral and fMRI
Measured: 3-month
Secondary outcomes (1)
Cognition - executive function behavioral reaction time
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Etkin, Stanford University
- Investigators
- Anett Gyurak, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694303
- Sponsor's protocol ID
- IRB-24519
- Status last verified
- Jul 2015
- First submitted
- 24 Sep 2012
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gyurak A, Patenaude B, Korgaonkar MS, Grieve SM, Williams LM, Etkin A. Frontoparietal Activation During Response Inhibition Predicts Remission to Antidepressants in Patients With Major Depression. Biol Psychiatry. 2016 Feb 15;79(4):274-81. doi: 10.1016/j.biopsych.2015.02.037. Epub 2015 Mar 27.
PubMed 25891220
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
- ClinicalTrials.gov ID
- NCT01694303
- Acronym / sponsor ID
- IRB-24519
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.
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 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- internet access
Key exclusion criteria (2 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
Emotion-regulation - behavioral and fMRI
Time frame: 3-month
1 secondary outcome
Cognition - executive function behavioral reaction time
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Derived from this study: PubMed 25891220Gyurak A, Patenaude B, Korgaonkar MS, Grieve SM, Williams LM, Etkin A. Frontoparietal Activation During Response Inhibition Predicts Remission to Antidepressants in Patients With Major Depression. Biol Psychiatry. 2016 Feb 15;79(4):274-81. doi: 10.1016/j.biopsych.2015.02.037. Epub 2015 Mar 27.
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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.
Anett Gyurak, 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 Healthy, 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 1 inclusion and 2 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 17 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotion-regulation - behavioral and fMRI (time frame: 3-month). 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 NCT01694303, which also lists 1 linked publication.
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 17 Jul 2015.