- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05383248
Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
November 28, 2023 updated by: Katia Harle, University of California, San Diego
Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders.
Untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia are fraught with poor patient compliance in real-life settings.
The proposed study aims to address this gap by 1) testing the usefulness of a non-invasive, computationally informed, cognitive training in boosting reward sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the neurocomputational mechanisms of change associated with such intervention.
In other words, can we train the brain to obtain rewards and boost positive mood among depressed and anxious individuals?
This project will help to develop a computational training protocol aimed at reducing anhedonia and improving existing interventions for psychiatric conditions characterized by reward processing deficits.
Long-term goals include expanding this framework to a broader range of appetitive and social stimuli to develop precise cognitive training tools to treat anhedonia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
California
-
La Jolla, California, United States, 92093
- UCSD Center for Functional Magnetic Resonance Imaging
-
-
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
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-65 (all races, both males and females will be included)
- Current diagnosis of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD)
- A score < 7 on the Snaith-Hamilton Pleasure Scale (SHAPS) or < 25 on the Positive Affect subscale from the Positive And Negative Affect Scale (PANAS)
- Sufficient proficiency in English language to understand and complete informed consent, interviews, questionnaires, and all other study procedures.
- Having normal or corrected vision
- Having normal or corrected hearing
Exclusion Criteria:
- Endorsement of past or current psychotic or bipolar disorder.
- Endorsement of recent severe alcohol or substance use disorder (past 3 months).
- Inability to discontinue for 48 hours prior to scan any medications incompatible with measuring reliable/interpretable neural activity (e.g., e.g., benzodiazepines/beta-blockers, atypical anti-depressants, anxiolytics and sedative hypnotics, antipsychotics, and opioid analgesics)
- Being unsafe to undergo functional magnetic resonance imaging (fMRI), i.e., being pregnant, presence of non-removable metal in body, medical conditions that are incompatible with safe MRI (e.g., claustrophobia, inability to lie still on one's back for approximately 60 minutes; prior neurosurgery)
- Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation): These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Reward - High Variance
|
Computerized reward learning task designed to increase reward responsiveness
|
|
Active Comparator: High Reward - Low Variance
|
Computerized reward learning task designed to have minimal effect on reward responsiveness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reward Maximization
Time Frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
|
Individually fitted computational parameter of reward maximization strategy during the reward learning task
|
Change between Pre-Training and Post-Training Assessments (about 20 min)
|
|
Positive Affect
Time Frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
|
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
|
Change between Pre-Training and Post-Training Assessments (about 20 min)
|
|
Neural Tracking of Reward Expectation
Time Frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
|
Neural activity, i.e., blood oxygen level dependent (BOLD) response, in the striatum and medial prefrontal cortex correlating with participants' trial-level model-based reward expectations and associated prediction errors during the Reward Learning Task
|
Change between Pre-Training and Post-Training Assessments (about 20 min)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 14, 2022
Primary Completion (Actual)
November 16, 2023
Study Completion (Actual)
November 16, 2023
Study Registration Dates
First Submitted
May 16, 2022
First Submitted That Met QC Criteria
May 16, 2022
First Posted (Actual)
May 20, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 309646-00001
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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