Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

NCT05383248 | Completed

• 1 other identifier: 309646-00001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anhedonia; Depression

Outcome Measures

Primary Outcomes (3)

• Reward Maximization

  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

  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

  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)

Study Arms (2)

High Reward - High Variance

EXPERIMENTAL

Behavioral: High Reward - High Variance

High Reward - Low Variance

ACTIVE COMPARATOR

Behavioral: High Reward - Low Variance

Interventions

High Reward - High Variance BEHAVIORAL

Computerized reward learning task designed to increase reward responsiveness

High Reward - High Variance

High Reward - Low Variance BEHAVIORAL

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

High Reward - Low Variance

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Center for Functional Magnetic Resonance Imaging

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Anhedonia; Depression

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 20, 2022
• Study Start: September 14, 2022
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)