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

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ClinicalTrials.gov Identifier: NCT01616797
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression, Anxiety Cognitive Training Emotion Training Emotion Regulation Behavioral: Computerized 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression
Study Start Date : February 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Computerized intervention
Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games.
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.
Sham Comparator: Control
Participants will be asked to visit a customized website and engage in computerized games.
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.


Outcome Measures

Primary Outcome Measures :
  1. Completion [ Time Frame: 60 days ]
    We anticipate that participants will complete at least 30-days of the intervention.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616797


Contacts
Contact: Jillian Autea jillian.autea@stanford.edu
Contact: Jennifer Ma jennma@stanford.edu

Locations
United States, California
VA Palo Alto Health Care System (VAPAHCS) Recruiting
Palo Alto, California, United States, 94304
Contact: Emmanuel Shpigel    510-668-1526    emman@stanford.edu   
Contact: Jillian Autea, MPA    650.493.5000 ext 64476    jillian.autea@stanford.edu   
Principal Investigator: Amit Etkin, MD, PhD         
Stanford University Department of Pscyhiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 94304
Principal Investigator: Amit Etkin, MD PhD         
Sponsors and Collaborators
Stanford University
More Information

Additional Information:
Responsible Party: Amit Etkin, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01616797     History of Changes
Other Study ID Numbers: IRB-24813
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders