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NCT01616797 Clinical Trial

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

Depression, Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01616797
Other study ID # IRB-24813
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date August 2018

Study information
Verified date September 2018
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Computerized neurobehavioral intervention
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.

Locations
Country Name City State
United States VA Palo Alto Health Care System (VAPAHCS) Palo Alto California
United States Stanford University Department of Pscyhiatry and Behavioral Sciences Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completion We anticipate that participants will complete at least 30-days of the intervention. 60 days
Primary 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
Primary 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
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