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OpenTrials
Completed

NCT Number: NCT05383248

Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Functional Magnetic Resonance Imaging

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Reward - High Variance

Behavioral

Computerized reward learning task designed to increase reward responsiveness

High Reward - Low Variance

Behavioral

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

Primary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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