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Completed

NCT Number: NCT01616797

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

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

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognitive Training Depression Emotion Regulation Emotion Training Emotional Regulation Mental Disorders Self-Control Social Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized neurobehavioral intervention

Behavioral

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2012
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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