Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

Sponsor

University of California, San Diego (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05383248

Collaborator

(none)

Enrollment

Arms

19.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anhedonia Depression	Behavioral: High Reward - High Variance Behavioral: High Reward - Low Variance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

Anticipated Study Start Date :

May 18, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Reward - High Variance	Behavioral: High Reward - High Variance Computerized reward learning task designed to increase reward responsiveness
Active Comparator: High Reward - Low Variance	Behavioral: High Reward - Low Variance Computerized reward learning task designed to have minimal effect on reward responsiveness

Arm

Intervention/Treatment

Experimental: High Reward - High Variance

Behavioral: High Reward - High Variance

Computerized reward learning task designed to increase reward responsiveness

Active Comparator: High Reward - Low Variance

Behavioral: High Reward - Low Variance

Computerized reward learning task designed to have minimal effect on reward responsiveness

Outcome Measures

Primary Outcome Measures

Reward Maximization [Change between Pre-Training and Post-Training Assessments (about 20 min)]
Individually fitted computational parameter of reward maximization strategy during the reward learning task
Positive Affect [Change between Pre-Training and Post-Training Assessments (about 20 min)]
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
Neural Tracking of Reward Expectation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katia Harle, Assistant Clinical Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05383248

Other Study ID Numbers:

309646-00001

First Posted:

May 20, 2022

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anhedonia

Study Results

No Results Posted as of May 20, 2022