- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025838
Positive Feedback vs. No-Feedback Games for Behavioral Change
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We know that behavior influences mood -- our best interventions to improve mood rely upon the relationship between these. Treatments like this are thought to work in part by helping individuals to increase value-derived behaviors; participants are given guidance which results in an increase of positive behaviors and a decrease of coping behaviors that don't help -- that is, their health-seeking behavior is reinforced while behaviors that diminish health are reduced. In past work, we showed that a text-based game could be used to explore what sort of decisions people would make in certain environments. That game showed associations between in-game behaviors and real-life depressive symptoms and actions. Such work focuses on low-level symptoms of depression -- increasingly common, especially after the onset of the covid-19 pandemic. 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.
Thus, the experiment described below and proposed in this application would test the role of positive rewards (positive-feedback) in a dichotomous-choice game, compared to neutral (no-feedback).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin Dainer-Best, Ph.D.
- Phone Number: 845-758-7223
- Email: jdainerbest@bard.edu
Study Locations
-
-
New York
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Annandale-on-Hudson, New York, United States, 12504
- Online research conducted through Bard College
-
Contact:
- Justin Dainer-Best, Ph.D.
- Email: jdainerbest@bard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-34 years old
- Fluent in English
- Based in the United States
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: positive feedback
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.
|
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.
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No Intervention: no feedback
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms (Patient Health Questionnaire-8 item)
Time Frame: baseline (T0) - before intervention
|
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
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Depressive symptoms (Patient Health Questionnaire-8 item)
Time Frame: one week following intervention (T1)
|
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)
|
Behavior in study-specific game
Time Frame: baseline (T0)
|
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)
|
Day Reconstruction Method (DRM)
Time Frame: baseline (T0) - before intervention
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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)
Time Frame: one week following intervention (T1)
|
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)
|
Motivation to change
Time Frame: baseline (T0) - after intervention
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood and Anxiety Symptoms Questionnaire (MASQ)
Time Frame: baseline (T0) - before intervention
|
The MASQ measures mood and anxiety symptoms on three subscales: Anhedonic Depression, Anxious Arousal, and General Distress.
Scores on each subscale range from 10 (low symptoms) to 50 (high symptoms).
Higher scores indicate more depression, anxiety, and distress.
|
baseline (T0) - before intervention
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Mood Ratings
Time Frame: baseline (T0) - before intervention
|
Mood will be rated on positive and negative scales: "On the whole, how sad were you today?" (Rated from 0 [not at all] to 6 [extremely]); "On the whole, how happy were you today?" (Rated from 0 [not at all] to 6 [extremely]).
Higher scores indicate more sadness or happiness.
|
baseline (T0) - before intervention
|
Mood Ratings
Time Frame: one week following intervention (T1)
|
Mood will be rated on positive and negative scales: "On the whole, how sad were you today?" (Rated from 0 [not at all] to 6 [extremely]); "On the whole, how happy were you today?" (Rated from 0 [not at all] to 6 [extremely]).
Higher scores indicate more sadness or happiness.
|
one week following intervention (T1)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Justin Dainer-Best, Ph.D., Bard College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FeedbackGames
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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