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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01616797
First received: June 7, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.


Condition Intervention Phase
Depression, Anxiety
Cognitive Training
Emotion Training
Emotion Regulation
Behavioral: Computerized neurobehavioral intervention
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Completion [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    We anticipate that participants will complete at least 30-days of the intervention.

  • Proximal outcomes [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    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.

  • Distal outcomes [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    We anticipate that anxiety and depression symptoms, explicit emotion regulation capacities and quality of life reported on self-report measures will show improvement.


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616797

Contacts
Contact: Rita Hitching (650) 725-9510 psychiatry@stanford.edu

Locations
United States, California
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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01616797     History of Changes
Other Study ID Numbers: IRB-24813
Study First Received: June 7, 2012
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014