A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression

Conditions
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Depression, Anxiety, Cognitive Training, Emotion Training, Emotion Regulation

Intervention / Treatment
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* Behavioral: Computerized neurobehavioral intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7. Exclusion Criteria: Current medication for psychiatric disorders Pregnant females Head trauma or injury that resulted in loss of consciousness MRI contraindication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized intervention<br>Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games. | Behavioral: Computerized neurobehavioral intervention<br>* 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.<br>|
| Sham Comparator: Control<br>Participants will be asked to visit a customized website and engage in computerized games. | Behavioral: Computerized neurobehavioral intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |