Major Depressive DisorderNCT06025838
Positive Feedback vs. No-Feedback Games for Behavioral Change
A study testing positive feedback in people with Major Depressive Disorder and Low Mood, run by Bard College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Low Mood
- What is being tested?
- positive feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 2 Mar 2024
- 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 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-34 years old
- Fluent in English
- Based in the United States
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Online research conducted through Bard College
Annandale-on-Hudson, New York, 12504
About this study
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.
Read the 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).
- Conditions
- Major Depressive Disorder, Low Mood
- Being tested
- positive feedback
- Medical subject headings
- Depressive Disorder, Major, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline (T0) - after intervention
Secondary outcomes (3)
Mood and Anxiety Symptoms Questionnaire (MASQ)
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.
Measured: baseline (T0) - before intervention
Mood Ratings
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.
Measured: baseline (T0) - before intervention
Mood Ratings
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.
Measured: one week following intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start13 Feb 2024
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bard College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Dainer-Best, Bard College
- Investigators
- Justin Dainer-Best, Ph.D., Principal investigator, Bard College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025838
- Sponsor's protocol ID
- FeedbackGames
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on the Open Science Framework, https://osf.io
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Feedback vs. No-Feedback Games for Behavioral Change
- ClinicalTrials.gov ID
- NCT06025838
- Acronym / sponsor ID
- FeedbackGames
- Conditions
- Major Depressive Disorder, Low Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Bard CollegeUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 6 Sep 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| positive feedback | Experimental | Behavioral: positive feedbackParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-34 years old
- Fluent in English
- Based in the United States
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| positive feedbackThe 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. | Behavioural | positive feedback |
Primary outcome
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.
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.
Day Reconstruction Method (DRM)
Time frame: baseline (T0) - before intervention
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).
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).
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.
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.
3 secondary outcomes
Mood and Anxiety Symptoms Questionnaire (MASQ)
Time frame: baseline (T0) - before intervention
Mood Ratings
Time frame: baseline (T0) - before intervention
Mood Ratings
Time frame: one week following intervention (T1)
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 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be shared on the Open Science Framework, https://osf.io
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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.
Justin Dainer-Best, Ph.D. principal investigator
Bard College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive feedback in people with Major Depressive Disorder and Low Mood, run by Bard College 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 3 inclusion and 1 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 14 Aug 2025. 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?
Depressive symptoms (Patient Health Questionnaire-8 item) (time frame: baseline (T0) - before intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.