DepressionNCT03538535
Set Your Goal: Engaging Go/No-Go Active Learning
A study testing Go/No-Go Active Learning (GOAL) in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Go/No-Go Active Learning (GOAL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Go/No-Go Active Learning (GOAL)
- Keywords
- reinforcement learning, computational models, neuroimaging
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go/No-Go Active Learning (GOAL)Behavioural
Behavioral Activation psychotherapy adapted to engage go/no-go learning
| Study group | Role | What they receive |
|---|---|---|
| Go/No-Go Active Learning (GOAL) | Experimental | Adaptation of Behavioral Activation, focused on reinforcement learning strategies. Receives: Behavioral: Go/No-Go Active Learning (GOAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 May 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adapted version of Behavioral Activation psychotherapy designed to optimize decision making and learning.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackie Gollan, Ph.D., Principal investigator, Associate Professor of Psychiatry and Behavioral Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538535
- Sponsor's protocol ID
- STU00206862
- Status last verified
- Jun 2022
- First submitted
- 14 May 2018
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huys QJM, Russek EM, Abitante G, Kahnt T, Gollan JK. Components of Behavioral Activation Therapy for Depression Engage Specific Reinforcement Learning Mechanisms in a Pilot Study. Comput Psychiatr. 2022 Oct 13;6(1):238-255. doi: 10.5334/cpsy.81. eCollection 2022.
PubMed 38774780
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Modeling of Reinforcement Learning in Depression
- ClinicalTrials.gov ID
- NCT03538535
- Acronym / sponsor ID
- STU00206862
- Conditions
- Depression, Anxiety
- Keywords
- reinforcement learning, computational models, neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adapted version of Behavioral Activation psychotherapy designed to optimize decision making and learning.
| Arm | Type | Receives |
|---|---|---|
| Go/No-Go Active Learning (GOAL) | Experimental | Behavioral: Go/No-Go Active Learning (GOAL)Adaptation of Behavioral Activation, focused on reinforcement learning strategies. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go/No-Go Active Learning (GOAL)Behavioral Activation psychotherapy adapted to engage go/no-go learning | Behavioural | Go/No-Go Active Learning (GOAL) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 38774780Huys QJM, Russek EM, Abitante G, Kahnt T, Gollan JK. Components of Behavioral Activation Therapy for Depression Engage Specific Reinforcement Learning Mechanisms in a Pilot Study. Comput Psychiatr. 2022 Oct 13;6(1):238-255. doi: 10.5334/cpsy.81. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Gollan, Ph.D. principal investigator
Associate Professor of Psychiatry and Behavioral Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go/No-Go Active Learning (GOAL) in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.