Back to resultsValuation in Depressed Mood, Anhedonia, and Anxiety
Primary Purpose
Neurobehavioral Components of Reward and Loss Valuation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy
valuation with instruction
valuation without instruction
Sponsored by
About this trial
This is an interventional basic science trial for Neurobehavioral Components of Reward and Loss Valuation focused on measuring depression, anxiety, anhedonia
Eligibility Criteria
Inclusion Criteria:
- mood, anxiety, or anhedonia symptoms that affect functioning; fluent in English; able to see computer display; able to perform simple computer games.
Exclusion Criteria:
- history of seizure disorder, stroke, or head injury with more than 10 minutes of unconsciousness; hormone disorder; electroconvulsive therapy within 5 years; history of chemotherapy for cancer; current pregnancy; contraindications to MRI
Sites / Locations
- Fralin Biomedical Research Institute at Virginia Tech CarilionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cognitive behavioral therapy
Valuation with instruction
Valuation without instruction
Arm Description
cognitive behavioral therapy for depression, anxiety, and/or anhedonia
repeat laboratory sessions of a reward/loss learning computer game with specific instructions
repeat laboratory sessions of a reward/loss learning computer game without specific instructions
Outcomes
Primary Outcome Measures
change in proportion correct on the 'N-arm bandit learning task'
change in proportion correct on 'N-arm bandit reinforcement learning task' from study entrance to study exit
Secondary Outcome Measures
change in depression symptoms (Beck Depression Inventory)
change in depression symptoms from study entrance to study exit
change in anxiety symptoms (anxiety subscale; Mood and Anxiety Symptom Questionnaire)
change in anxiety symptoms from study entrance to study exit
change in anhedonia symptoms (anhedonia subscale; Mood and Anxiety Symptom Questionnaire)
change in anhedonia symptoms from study entrance to study exit
Full Information
NCT ID
NCT05384158
First Posted
May 13, 2022
Last Updated
May 17, 2022
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT05384158
Brief Title
Valuation in Depressed Mood, Anhedonia, and Anxiety
Official Title
Evaluating Overlap and Distinctiveness in Neurocomputational Loss and Reward Elements of the RDoC Matrix
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines how people respond to rewards and losses, and the extent to which these responses are linked or distinct among people experiencing depressed mood, anhedonia, and/or anxiety.
Detailed Description
This study tests relationships among neural and behavioral valuation mechanisms, and how these mechanisms change (or not) over time, with task instructions, and following cognitive behavior therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurobehavioral Components of Reward and Loss Valuation
Keywords
depression, anxiety, anhedonia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
cognitive behavioral therapy for depression, anxiety, and/or anhedonia
Arm Title
Valuation with instruction
Arm Type
Active Comparator
Arm Description
repeat laboratory sessions of a reward/loss learning computer game with specific instructions
Arm Title
Valuation without instruction
Arm Type
Active Comparator
Arm Description
repeat laboratory sessions of a reward/loss learning computer game without specific instructions
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
valuation with instruction
Intervention Description
repeat laboratory sessions of computerized learning game
Intervention Type
Behavioral
Intervention Name(s)
valuation without instruction
Intervention Description
repeat laboratory sessions of computerized learning game
Primary Outcome Measure Information:
Title
change in proportion correct on the 'N-arm bandit learning task'
Description
change in proportion correct on 'N-arm bandit reinforcement learning task' from study entrance to study exit
Time Frame
study entrance to study exit, an average of 12 weeks
Secondary Outcome Measure Information:
Title
change in depression symptoms (Beck Depression Inventory)
Description
change in depression symptoms from study entrance to study exit
Time Frame
study entrance to exit, an average of 12 weeks
Title
change in anxiety symptoms (anxiety subscale; Mood and Anxiety Symptom Questionnaire)
Description
change in anxiety symptoms from study entrance to study exit
Time Frame
study entrance to exit, an average of 12 weeks
Title
change in anhedonia symptoms (anhedonia subscale; Mood and Anxiety Symptom Questionnaire)
Description
change in anhedonia symptoms from study entrance to study exit
Time Frame
study entrance to exit, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mood, anxiety, or anhedonia symptoms that affect functioning; fluent in English; able to see computer display; able to perform simple computer games.
Exclusion Criteria:
history of seizure disorder, stroke, or head injury with more than 10 minutes of unconsciousness; hormone disorder; electroconvulsive therapy within 5 years; history of chemotherapy for cancer; current pregnancy; contraindications to MRI
Facility Information:
Facility Name
Fralin Biomedical Research Institute at Virginia Tech Carilion
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pearl Chiu, PhD
Phone
540-526-2032
Email
chiup@vtc.vt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Valuation in Depressed Mood, Anhedonia, and Anxiety
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