- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538535
Set Your Goal: Engaging Go/No-Go Active Learning
June 9, 2022 updated by: Northwestern University
Computational Modeling of Reinforcement Learning in Depression
This study will test a computational model reinforcement learning in depression and anxiety and test the extent to which the computational model predicts response to an adapted version of behavioral activation psychotherapy.
The model will be based on a data from a computer task of reinforcement learning during 3T functional magnetic resonance imaging at baseline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The dysfunction of reinforcement learning is emerging as a transdiagnostic dimension of mood and anxiety.
Computational models of reinforcement learning may expedite our ability to identify predictors of response, thereby improving efficacy rates.
We will will, first, examine the neural substrates of reinforcement learning in depression and anxiety, and, second, test a computational model of reinforcement learning as a predictor of response to an adapted version of behavioral activation psychotherapy.
Subjects (N=10) will be enrolled in a two week evaluation, followed with a nine week weekly intervention program.
Assessments will be conducted at baseline, and during the intervention as the 3-, 6-, 9-week follow-ups.
Reinforcement learning will be measured using 3T magnetic resonance imaging during a computer task.
All other measures include structured clinical interviews, questionnaires, and computer tasks.
Study Type
Interventional
Enrollment (Actual)
13
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 Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
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-
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
21 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 21 and 40
- Physically healthy
- Right handed
- Normal or corrected to normal vision
- Scores equal or higher of (a) 24 on Inventory of Depressive Symptomatology, Self Report, or (b) 15 on the Generalized Anxiety Disorder Self Report.
Exclusion Criteria:
- Not currently in therapy or taking medications for anxiety or depression
- No contraindications for the magnetic resonance scan (claustrophobic)
- No history of head trauma, seizures, loss of consciousness
- Not taking hormone replacement, not pregnant
- No imminent suicidality
- No report of excessive alcohol or drug use in past three months
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Go/No-Go Active Learning (GOAL)
Adaptation of Behavioral Activation, focused on reinforcement learning strategies.
|
Behavioral Activation psychotherapy adapted to engage go/no-go learning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Integrated Bayesian Information Criterion (BIC) score based on models using modified Q-learning models with two pairs of action values (go and no-go) for each state.
Time Frame: Baseline (Week 0)
|
Models will include a learning rate, a slope of the softmax rule, noise factor, a bias factor to the action-value for 'go', and a Pavlovian factor.
|
Baseline (Week 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jackie Gollan, Ph.D., Associate Professor of Psychiatry and Behavioral Science
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 (Actual)
May 1, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
May 24, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00206862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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