Back to resultsA Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
Primary Purpose
Depression, Anxiety, Cognitive Training, Emotion Training
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized neurobehavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety
Eligibility 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
Sites / Locations
- VA Palo Alto Health Care System (VAPAHCS)
- Stanford University Department of Pscyhiatry and Behavioral Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Computerized intervention
Control
Arm Description
Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games.
Participants will be asked to visit a customized website and engage in computerized games.
Outcomes
Primary Outcome Measures
Completion
We anticipate that participants will complete at least 30-days of the intervention.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01616797
Brief Title
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
Official Title
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Cognitive Training, Emotion Training, Emotion Regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized intervention
Arm Type
Experimental
Arm Description
Participants will be asked to visit a customized website and engage in computerized exercises. Cognitive and emotion training games.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will be asked to visit a customized website and engage in computerized games.
Intervention Type
Behavioral
Intervention Name(s)
Computerized neurobehavioral intervention
Intervention Description
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 Outcome Measure Information:
Title
Completion
Description
We anticipate that participants will complete at least 30-days of the intervention.
Time Frame
60 days
Title
Proximal outcomes
Description
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.
Time Frame
60 days
Title
Distal outcomes
Description
We anticipate that anxiety and depression symptoms, explicit emotion regulation capacities and quality of life reported on self-report measures will show improvement.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
VA Palo Alto Health Care System (VAPAHCS)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Department of Pscyhiatry and Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
We'll reach out to this number within 24 hrs