Can Computational Measures of Task Performance Predict Psychiatric Symptoms and Changes in Symptom Severity Across Time (CABxtime)

November 21, 2024 updated by: John P. O'Doherty, PhD, California Institute of Technology

Leveraging Computationally Derived Measures of Individual Differences in Learning and Decision-making to Predict Psychiatric Diagnosis, Symptoms and Changes in Symptom Severity Across Time

This study investigates the computational mechanisms associated with psychiatric disease dimensions. The study will characterize the relationship between computational parameter estimates of task performance and psychiatric symptoms and diagnoses with a longitudinal approach over a 12 month interval. Participants will be healthy participants recruited through Prolific an on-line crowdsourcing service, and psychiatric patients and healthy participants recruited via UCLA Psychiatry Clinics and UCLA's STAND Program

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of computational psychiatry is to gain knowledge about underlying neurocomputational processes that underpin psychiatric disorders and to leverage this knowledge for improving diagnosis and treatment. A key step toward achieving this goal is to develop measures of individual differences in computations obtained from a single individual that are reliable, robust and meaningfully relevant to psychiatric dysfunction. In order to attain these objectives, it is essential we substantiate relationships between candidate computational mechanisms and diagnostic categories, symptom dimensions and treatment outcomes. In the present study, a computational assessment task battery (CAB) will be utilized that is designed to measure individual differences across a multidimensional array of computational processes. The study aims to separate three different variance components contributing to variability in computational parameter estimation: occasion-related variance due to incidental day to day changes in task performance, state-dependent variance that is related to meaningful variation across time in the underlying computations within an individual, and trait-related differences pertaining to stable individual differences in computations across individuals. To accomplish this, repeated assessments will be implemented using this battery across a 1-year interval within an on-line sample, and use hierarchical Bayesian modeling to separate the effect of occasion, state and trait-related variance on these parameter estimates. These variance components will then be related to diagnostic categories, symptom dimensions and symptom severity measures in a diverse cohort of psychiatric patients (mostly with depression, anxiety and OCD) recruited in Southern California. Finally, the relationship will be tracked between the computational parameter estimates and changes in symptoms across time in a subset of these patients. This study promises to significantly advance understanding of how to reliably extract diagnostically relevant computationally-derived measures of cognitive phenotypes that could eventually be migrated to the clinic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
        • Contact:
      • Pasadena, California, United States, 91125
        • California Insitute of Technology
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria (healthy control participants):

  • Age range of 18 to 65.
  • Not currently having a psychiatric diagnosis determined after psychiatric evaluation by Drs. Tadayon-Nejad and Wei (both are board certified psychiatrists).
  • Ability to understand and perform experimental tasks, i.e. basic ability to communicate and comprehend tasks.
  • Ability to give informed consent.

Exclusion criteria (healthy control participants):

• Prior history and or current diagnosis of neurological disease.

Inclusion criteria (patients):

  • Age range of 18 to 65.
  • Psychiatric diagnosis of any type of depressive disorders, any type of anxiety disorders or obsessive-compulsive disorder.
  • Primary or comorbid bipolar disorders are allowed but only if not in the acute manic phase.
  • Comorbidity with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are allowed.
  • Ability to understand and perform experimental tasks, i.e. basic ability to communicate and comprehend tasks.
  • Ability to give informed consent.

Exclusion criteria (patients):

  • Prior history and or current diagnosis of neurological disease.
  • History or current diagnosis of psychotic disorders.
  • Currently active substance use disorder.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Behavioral task battery
Behavioral: Behavioral task performance
Measures of performance on behavioral tasks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in DASS depression scale scores
Time Frame: 12 months
Changes in computational parameter estimates related to gain/loss learning, reward/effort tradeoff and reward/predation risk tradeoffs will correlate with changes in DASS depression scale scores across time.
12 months
Changes in DASS anxiety scale scores
Time Frame: 12 months
Changes in computational parameter estimates related to novelty driven exploration and reward/predation risk tradeoffs will be correlated with changes in DASS anxiety scale scores
12 months
Changes in OCI-R scores
Time Frame: 12 months
Changes in computational parameter estimates related to the balance between model-based vs model-free reinforcement-learning will be correlated with changes in OCI-R symptoms across time.
12 months
OCI-R scores
Time Frame: 12 months
Computational parameter estimates related to the balance between model-based vs model-free reinforcement-learning will be correlated with OCI-R scores.
12 months
DASS depression scale scores
Time Frame: 12 months
Computational parameter estimates related to gain/loss learning, reward/effort tradeoff and reward/predation risk tradeoffs will correlate with DASS depression scale scores.
12 months
DASS anxiety scale scores
Time Frame: 12 months
Computational parameter estimates related to novelty driven exploration and reward/predation risk tradeoffs will be correlated with DASS anxiety scale scores
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John P O'Doherty, D.Phil, California Institute of Technology

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01MH138895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual task performance data will be provided (trial data) and individual questionnaire scores will be available.

IPD Sharing Access Criteria

Data will be provided to the NIH NDA database as requested per the grant conditions,

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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