- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06705179
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
Not yet recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
1100
Phase
- 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
- Name: John P O'Doherty, D.Phil
- Phone Number: 626-395-5981
- Email: jdoherty@hss.caltech.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
-
Contact:
- Reza Tadayon-nejad, MD PhD
- Phone Number: 310-206-6389
- Email: RTadayonNejad@mednet.ucla.edu
-
Pasadena, California, United States, 91125
- California Insitute of Technology
-
Contact:
- John O'Doherty, D Phil
- Phone Number: 626-395-5981
- Email: jdoherty@hss.caltech.edu
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Behavioral task battery
|
Measures of performance on behavioral tasks
|
What is the study measuring?
Primary Outcome Measures
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.
Investigators
- 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)
January 1, 2025
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
November 18, 2024
First Submitted That Met QC Criteria
November 21, 2024
First Posted (Estimated)
November 26, 2024
Study Record Updates
Last Update Posted (Estimated)
November 26, 2024
Last Update Submitted That Met QC Criteria
November 21, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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