A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
1 other identifier
interventional
68
1 country
2
Brief Summary
The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 7, 2018
September 1, 2018
4.5 years
June 7, 2012
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Completion
We anticipate that participants will complete at least 30-days of the intervention.
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.
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.
5 months
Study Arms (2)
Computerized intervention
EXPERIMENTALParticipants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games.
Control
SHAM COMPARATORParticipants will be asked to visit a customized website and engage in computerized games.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7.
You may not qualify if:
- Current medication for psychiatric disorders
- Pregnant females
- Head trauma or injury that resulted in loss of consciousness
- MRI contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304, United States
Stanford University Department of Pscyhiatry and Behavioral Sciences
Stanford, California, 94304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 12, 2012
Study Start
February 1, 2014
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 7, 2018
Record last verified: 2018-09