Positive Feedback vs. No-Feedback Games for Behavioral Change

Major Depressive Disorder Clinical Trial

Official title:

Positive Feedback vs. No-Feedback Games for Behavioral Change

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06025838
• Other study ID #: FeedbackGames
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2023
• Source: Bard College
• Contact: Justin Dainer-Best, Ph.D.
• Phone: 845-758-7223
• Email: jdainerbest[@]bard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• 18-34 years old

• Fluent in English

• Based in the United States

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Low Mood
• Major Depressive Disorder

Intervention

Behavioral:
• positive feedback
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.

Locations

Country	Name	City	State
United States	Online research conducted through Bard College	Annandale-on-Hudson	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bard College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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	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.	baseline (T0) - before intervention
Secondary	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.	baseline (T0) - before intervention
Secondary	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.	one week following intervention (T1)