Depression, AnxietyNCT01616797
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
A study testing Computerized neurobehavioral intervention in people with Depression, Anxiety and Cognitive Training, run by Stanford University at 2 sites in United States.
Trial summary
The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety, Cognitive Training, Emotion Training
- What is being tested?
- Computerized neurobehavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Aug 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7.
Who cannot join
- Current medication for psychiatric disorders
- Pregnant females
- Head trauma or injury that resulted in loss of consciousness
- MRI contraindication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304
Stanford University Department of Pscyhiatry and Behavioral Sciences
Stanford, California, 94304
About this study
Official title: A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression
The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.
Read the detailed description
Participants will be recruited locally in the San Francisco Bay area with certain symptoms of anxiety and depression. They will complete a clinical assessment and then take part in a cognitive-emotion training delivered online.
- Being tested
- Computerized neurobehavioral intervention
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized neurobehavioral interventionBehavioural
Participants will complete the intervention by logging into a secure online website and complete computerized neurobehavioral tasks. Tasks will train the following - cognitive control, working memory and task shifting with two different tasks that engage these skills and positivity biases.
| Study group | Role | What they receive |
|---|---|---|
| Computerized intervention | Experimental | Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games. Receives: Behavioral: Computerized neurobehavioral intervention |
| Control | Sham comparator | Participants will be asked to visit a customized website and engage in computerized games. Receives: Behavioral: Computerized neurobehavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion
We anticipate that participants will complete at least 30-days of the intervention.
Measured: 60 days
Proximal outcomes
We anticipate that proximal measures of symptoms will show improvement following the training in terms of emotional reactivity, implicit emotion regulation, negative emotional memory bias, attentional bias for threat, executive functions behaviorally and N-back during fMRI as well as resting-state fMRI connectivity.
Measured: 60 days
Distal outcomes
We anticipate that anxiety and depression symptoms, explicit emotion regulation capacities and quality of life reported on self-report measures will show improvement.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startFeb 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Etkin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616797
- Sponsor's protocol ID
- IRB-24813
- Status last verified
- Sep 2018
- First submitted
- 7 Jun 2012
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression
- ClinicalTrials.gov ID
- NCT01616797
- Acronym / sponsor ID
- IRB-24813
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Jun 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 research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.
Detailed description
Participants will be recruited locally in the San Francisco Bay area with certain symptoms of anxiety and depression. They will complete a clinical assessment and then take part in a cognitive-emotion training delivered online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized intervention | Experimental | Behavioral: Computerized neurobehavioral interventionParticipants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games. |
| Control | Sham comparator | Behavioral: Computerized neurobehavioral interventionParticipants will be asked to visit a customized website and engage in computerized games. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7.
Key exclusion criteria (4 listed)
- Current medication for psychiatric disorders
- Pregnant females
- Head trauma or injury that resulted in loss of consciousness
- MRI contraindication
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 interventionParticipants will complete the intervention by logging into a secure online website and complete computerized neurobehavioral tasks. Tasks will train the following - cognitive control, working memory and task shifting with two different tasks that engage these skills and positivity biases. | Behavioural | Computerized intervention, Control |
Primary outcome
Completion
Time frame: 60 days
We anticipate that participants will complete at least 30-days of the intervention.
Proximal outcomes
Time frame: 60 days
We anticipate that proximal measures of symptoms will show improvement following the training in terms of emotional reactivity, implicit emotion regulation, negative emotional memory bias, attentional bias for threat, executive functions behaviorally and N-back during fMRI as well as resting-state fMRI connectivity.
Distal outcomes
Time frame: 5 months
We anticipate that anxiety and depression symptoms, explicit emotion regulation capacities and quality of life reported on self-report measures will show improvement.
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 7 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Depression, Anxiety and Cognitive Training, run by Stanford University at 2 sites 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 4 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Completion (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2018.