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Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

Primary Purpose

Anhedonia, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Reward - High Variance
High Reward - Low Variance
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anhedonia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UCSD Center for Functional Magnetic Resonance ImagingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Reward - High Variance

High Reward - Low Variance

Arm Description

Outcomes

Primary Outcome Measures

Reward Maximization
Individually fitted computational parameter of reward maximization strategy during the reward learning task
Positive Affect
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
October 17, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05383248
Brief Title
Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
Official Title
Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Reward - High Variance
Arm Type
Experimental
Arm Title
High Reward - Low Variance
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
High Reward - High Variance
Intervention Description
Computerized reward learning task designed to increase reward responsiveness
Intervention Type
Behavioral
Intervention Name(s)
High Reward - Low Variance
Intervention Description
Computerized reward learning task designed to have minimal effect on reward responsiveness
Primary Outcome Measure Information:
Title
Reward Maximization
Description
Individually fitted computational parameter of reward maximization strategy during the reward learning task
Time Frame
Change between Pre-Training and Post-Training Assessments (about 20 min)
Title
Positive Affect
Description
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
Time Frame
Change between Pre-Training and Post-Training Assessments (about 20 min)
Title
Neural Tracking of Reward Expectation
Description
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
Time Frame
Change between Pre-Training and Post-Training Assessments (about 20 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katia Harlé, PhD
Phone
(858) 534-2230
Email
kharle@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Dun
Phone
(858) 552-8585
Ext
2509
Email
d2dun@health.ucsd.edu
Facility Information:
Facility Name
UCSD Center for Functional Magnetic Resonance Imaging
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Dun, BS
Phone
858-552-8585
Ext
2509
Email
d2dun@health.ucsd.edu

12. IPD Sharing Statement

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Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients

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