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

Not Applicable

Completed

• Conditions: Cognitive Training; Emotion Regulation; Depression, Anxiety; Emotion Training
• Interventions: Behavioral: Computerized neurobehavioral intervention

• Registration Number: NCT01616797
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Study Start: 2014-02
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computerized intervention	Computerized neurobehavioral intervention	Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games.
Control	Computerized neurobehavioral intervention	Participants will be asked to visit a customized website and engage in computerized games.

Primary Outcome Measures

Name	Time	Method
Distal outcomes	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.
Completion	60 days	We anticipate that participants will complete at least 30-days of the intervention.
Proximal outcomes	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.

Trial Locations

Locations (2)

VA Palo Alto Health Care System (VAPAHCS); 🇺🇸 Palo Alto, California, United States

Stanford University Department of Pscyhiatry and Behavioral Sciences; 🇺🇸 Stanford, California, United States