NCT03538535

Brief 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. The model will be based on a data from a computer task of reinforcement learning during 3T functional magnetic resonance imaging at baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

May 14, 2018

Last Update Submit

June 9, 2022

Conditions

Keywords

reinforcement learningcomputational modelsneuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Week 0)

Study Arms (1)

Go/No-Go Active Learning (GOAL)

EXPERIMENTAL

Adaptation of Behavioral Activation, focused on reinforcement learning strategies.

Behavioral: Go/No-Go Active Learning (GOAL)

Interventions

Behavioral Activation psychotherapy adapted to engage go/no-go learning

Go/No-Go Active Learning (GOAL)

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Jackie Gollan, Ph.D.

    Associate Professor of Psychiatry and Behavioral Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Adapted version of Behavioral Activation psychotherapy designed to optimize decision making and learning.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 29, 2018

Study Start

May 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations