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Positive Feedback vs. No-Feedback Games for Behavioral Change

Primary Purpose

Major Depressive Disorder, Low Mood

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positive feedback
Sponsored by
Bard College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-34 years old Fluent in English Based in the United States Exclusion Criteria: None

Sites / Locations

  • Online research conducted through Bard College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

positive feedback

no feedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 30, 2023
Last Updated
September 5, 2023
Sponsor
Bard College
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1. Study Identification

Unique Protocol Identification Number
NCT06025838
Brief Title
Positive Feedback vs. No-Feedback Games for Behavioral Change
Official Title
Positive Feedback vs. No-Feedback Games for Behavioral Change
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bard College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Low Mood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
positive feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
no feedback
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
positive feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms (Patient Health Questionnaire-8 item)
Description
8 items rated in a self-report questionnaire. Scores range from 0 to 24 with higher scores indicating more depression symptoms.
Time Frame
baseline (T0) - before intervention
Title
Depressive symptoms (Patient Health Questionnaire-8 item)
Description
8 items rated in a self-report questionnaire. Scores range from 0 to 24 with higher scores indicating more depression symptoms.
Time Frame
one week following intervention (T1)
Title
Day Reconstruction Method (DRM)
Description
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).
Time Frame
baseline (T0) - before intervention
Title
Day Reconstruction Method (DRM)
Description
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).
Time Frame
one week following intervention (T1)
Title
Behavior in study-specific game
Description
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.
Time Frame
baseline (T0)
Title
Motivation to change
Description
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.
Time Frame
baseline (T0) - after intervention
Secondary Outcome Measure Information:
Title
Mood and Anxiety Symptoms Questionnaire (MASQ)
Description
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.
Time Frame
baseline (T0) - before intervention
Title
Mood Ratings
Description
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.
Time Frame
baseline (T0) - before intervention
Title
Mood Ratings
Description
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.
Time Frame
one week following intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-34 years old Fluent in English Based in the United States Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Dainer-Best, Ph.D.
Phone
845-758-7223
Email
jdainerbest@bard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Dainer-Best, Ph.D.
Organizational Affiliation
Bard College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online research conducted through Bard College
City
Annandale-on-Hudson
State/Province
New York
ZIP/Postal Code
12504
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Dainer-Best, Ph.D.
Email
jdainerbest@bard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared on the Open Science Framework, https://osf.io
IPD Sharing Time Frame
Data will be available on or before a manuscript is submitted for publication, likely in 2024, and will be shared indefinitely.
IPD Sharing Access Criteria
Open access. Anyone will be able to access de-identified data and code.

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Positive Feedback vs. No-Feedback Games for Behavioral Change

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