Valuation in Depressed Mood, Anhedonia, and Anxiety

December 19, 2023 updated by: Pearl Chiu, Virginia Polytechnic Institute and State University

Evaluating Overlap and Distinctiveness in Neurocomputational Loss and Reward Elements of the RDoC Matrix

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Fralin Biomedical Research Institute at Virginia Tech Carilion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive behavioral therapy
cognitive behavioral therapy for depression, anxiety, and/or anhedonia
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy
Active Comparator: Valuation with instruction
repeat laboratory sessions of a reward/loss learning computer game with specific instructions
Behavioral: valuation with instruction
repeat laboratory sessions of computerized learning game
Active Comparator: Valuation without instruction
repeat laboratory sessions of a reward/loss learning computer game without specific instructions
Behavioral: valuation without instruction
repeat laboratory sessions of computerized learning game

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in proportion correct on the 'N-arm bandit learning task'
Time Frame: study entrance to study exit, an average of 12 weeks
change in proportion correct on 'N-arm bandit reinforcement learning task' from study entrance to study exit
study entrance to study exit, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in depression symptoms (Beck Depression Inventory)
Time Frame: study entrance to exit, an average of 12 weeks
change in depression symptoms from study entrance to study exit
study entrance to exit, an average of 12 weeks
change in anxiety symptoms (anxiety subscale; Mood and Anxiety Symptom Questionnaire)
Time Frame: study entrance to exit, an average of 12 weeks
change in anxiety symptoms from study entrance to study exit
study entrance to exit, an average of 12 weeks
change in anhedonia symptoms (anhedonia subscale; Mood and Anxiety Symptom Questionnaire)
Time Frame: study entrance to exit, an average of 12 weeks
change in anhedonia symptoms from study entrance to study exit
study entrance to exit, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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