NCT06025838

Brief Summary

We aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game. Does providing positive reward when participants make decisions which are associated with value-based actions (like those in BA) result in different game decisions? We propose that it will increase positive actions in the game. And, secondly, how does it affect short-term behavior (in one week)? We propose that it will increase pro-health activities and may reduce depressive symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable major-depressive-disorder

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

First Submitted

Initial submission to the registry

August 30, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 13, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

18 days

First QC Date

August 30, 2023

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Depressive symptoms (Patient Health Questionnaire-8 item)

    8 items rated in a self-report questionnaire. Scores range from 0 to 24 with higher scores indicating more depression symptoms.

    baseline (T0) - before intervention

  • Depressive symptoms (Patient Health Questionnaire-8 item)

    8 items rated in a self-report questionnaire. Scores range from 0 to 24 with higher scores indicating more depression symptoms.

    one week following intervention (T1)

  • Day Reconstruction Method (DRM)

    The DRM measures how people spend their time and asks them how they felt while doing the activities they report. Ratings on a Likert scale indicate valence (how pleasant/unpleasant the activities were) and range from 0 (not at all) to 6 (very much), with higher pleasantness being better (and lower unpleasantness being better).

    baseline (T0) - before intervention

  • Day Reconstruction Method (DRM)

    The DRM measures how people spend their time and asks them how they felt while doing the activities they report. Ratings on a Likert scale indicate valence (how pleasant/unpleasant the activities were) and range from 0 (not at all) to 6 (very much), with higher pleasantness being better (and lower unpleasantness being better).

    one week following intervention (T1)

  • Behavior in study-specific game

    For both conditions, behavior and choices made during the game will be used as data for analyses. Game choices allow participants to decide what next activities they will "do" in the game. Analyses incorporate decision probabilities (which of 2 choices are selected) and compare them between conditions. The game is completed at baseline following assessment.

    baseline (T0)

  • Motivation to change

    A 7-point item, "It is important to me to do more positive activities in my life". Scores range from 0 \[not at all\] to 6 \[very much\]. Higher scores indicate more motivation to change.

    baseline (T0) - after intervention

Secondary Outcomes (3)

  • Mood and Anxiety Symptoms Questionnaire (MASQ)

    baseline (T0) - before intervention

  • Mood Ratings

    baseline (T0) - before intervention

  • Mood Ratings

    one week following intervention (T1)

Study Arms (2)

positive feedback

EXPERIMENTAL

Participants receive positive feedback and reward for their decisions taken during a small game similar to a normal person's life. For example, they are encouraged to exercise, make food, and interact with friends.

Behavioral: positive feedback

no feedback

NO INTERVENTION

Participants receive no feedback. While they may undertake the same decisions during a small game similar to a normal person's life, they receive no encouragement and are not given reward or positive feedback.

Interventions

The positive feedback game uses techniques relating to established therapies like Behavioral Activation and Acceptance and Commitment Therapy's valued living to encourage positive action in game and outside of the game.

positive feedback

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Fluent in English
  • Based in the United States

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online research conducted through Bard College

Annandale-on-Hudson, New York, 12504, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorConsciousness Disorders

Interventions

Feedback, Physiological

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

HomeostasisPhysiological Phenomena

Study Officials

  • Justin Dainer-Best, Ph.D.

    Bard College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The intervention occurs entirely online. All assessment occurs via survey software. Participants do not interact with other participants and are not fully informed of the nature of the intervention and thus do not know if they are in an active condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are either assigned to a control (no intervention) condition or to one where they receive positive feedback and are encouraged to specific, positive behavior.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 6, 2023

Study Start

February 13, 2024

Primary Completion

March 2, 2024

Study Completion

March 2, 2024

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data will be shared on the Open Science Framework, https://osf.io

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available on or before a manuscript is submitted for publication and will be shared indefinitely.
Access Criteria
Open access. Anyone will be able to access de-identified data and code.
More information

Locations