Guided Feedback in an Online Game Impacts Decision Making
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Active game
Neutral game
Sponsored by
About this trial
This is an interventional other trial for Depressive Symptoms focused on measuring depressive symptoms
Eligibility Criteria
Inclusion Criteria: 18+ age Eligible to participate in online research Able to read and respond in English Exclusion Criteria: None
Sites / Locations
- Bard College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Sham Comparator
No Intervention
Experimental
Active Comparator
Arm Label
Video
Active game
Neutral game
No intervention
Video + Active game
Video + Neutral game
Arm Description
Short video with BA intervention ideas
Feedback Twine game
Neutral Twine game
Combines Video and Active game
Combines Video and Neutral game
Outcomes
Primary Outcome Measures
patient health questionnaire (PHQ; 8 items)
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
patient health questionnaire (PHQ; 8 items)
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
Behavior in study-specific game
For participants completing the game (neutral or active), behavior and choices made 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 2-5 choices are selected) and compare them between conditions. The game is completed at baseline following assessment (and following video) for those assigned this arm only.
Secondary Outcome Measures
Generalized Anxiety Disorder 7 (GAD-7)
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
Generalized Anxiety Disorder 7 (GAD-7)
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
Full Information
NCT ID
NCT05925816
First Posted
June 14, 2023
Last Updated
June 22, 2023
Sponsor
Bard College
Collaborators
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT05925816
Brief Title
Guided Feedback in an Online Game Impacts Decision Making
Official Title
Understanding Decision Making Using a Text-based Game
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bard College
Collaborators
University of Texas at Austin
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
The purpose of the study is to evaluate the use of a text-based game as a way to understand decision making and knowledge related to anxiety, stress, and mood states like depression or loneliness. The investigators are interested in identifying whether participants who are given feedback before and during the game will report changes in behavior or depressive symptoms over the course of a one-week period. This is a follow-up to the published study from the researchers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depressive symptoms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Brief interventions are conducted online and thus largely masked. All assessment is also conducted through an online survey.
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video
Arm Type
Experimental
Arm Description
Short video with BA intervention ideas
Arm Title
Active game
Arm Type
Experimental
Arm Description
Feedback Twine game
Arm Title
Neutral game
Arm Type
Sham Comparator
Arm Description
Neutral Twine game
Arm Title
No intervention
Arm Type
No Intervention
Arm Title
Video + Active game
Arm Type
Experimental
Arm Description
Combines Video and Active game
Arm Title
Video + Neutral game
Arm Type
Active Comparator
Arm Description
Combines Video and Neutral game
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
Video uses BA techniques for approximately 5 minutes
Intervention Type
Behavioral
Intervention Name(s)
Active game
Intervention Description
Game provides positive feedback in response to decisions made by participants
Intervention Type
Behavioral
Intervention Name(s)
Neutral game
Intervention Description
Game without feedback
Primary Outcome Measure Information:
Title
patient health questionnaire (PHQ; 8 items)
Description
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
Time Frame
baseline (T0) - before intervention
Title
patient health questionnaire (PHQ; 8 items)
Description
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
Time Frame
one week following intervention (T1)
Title
Behavior in study-specific game
Description
For participants completing the game (neutral or active), behavior and choices made 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 2-5 choices are selected) and compare them between conditions. The game is completed at baseline following assessment (and following video) for those assigned this arm only.
Time Frame
Completed at baseline (T0)
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7 (GAD-7)
Description
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
Time Frame
Baseline (T0) before intervention
Title
Generalized Anxiety Disorder 7 (GAD-7)
Description
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
Time Frame
one-week follow-up (T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18+ age
Eligible to participate in online research
Able to read and respond in English
Exclusion Criteria:
None
Facility Information:
Facility Name
Bard College
City
Annandale-on-Hudson
State/Province
New York
ZIP/Postal Code
12504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and code for analyses have been shared on the Open Science Framework, https://osf.io/
IPD Sharing Time Frame
IPD will be available when the study is submitted for publication, beginning in 2023.
IPD Sharing Access Criteria
Anyone will be able to access de-identified data and code.
IPD Sharing URL
https://doi.org/10.17605/osf.io/mds4f
Learn more about this trial
Guided Feedback in an Online Game Impacts Decision Making
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