- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925816
Guided Feedback in an Online Game Impacts Decision Making
June 22, 2023 updated by: Justin Dainer-Best, Bard College
Understanding Decision Making Using a Text-based Game
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Annandale-on-Hudson, New York, United States, 12504
- Bard College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18+ age
- Eligible to participate in online research
- Able to read and respond in English
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Experimental: Video
Short video with BA intervention ideas
|
Video uses BA techniques for approximately 5 minutes
|
Experimental: Active game
Feedback Twine game
|
Game provides positive feedback in response to decisions made by participants
|
Sham Comparator: Neutral game
Neutral Twine game
|
Game without feedback
|
Experimental: Video + Active game
Combines Video and Active game
|
Video uses BA techniques for approximately 5 minutes
Game provides positive feedback in response to decisions made by participants
|
Active Comparator: Video + Neutral game
Combines Video and Neutral game
|
Video uses BA techniques for approximately 5 minutes
Game without feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient health questionnaire (PHQ; 8 items)
Time Frame: baseline (T0) - before intervention
|
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
|
baseline (T0) - before intervention
|
patient health questionnaire (PHQ; 8 items)
Time Frame: one week following intervention (T1)
|
The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.
|
one week following intervention (T1)
|
Behavior in study-specific game
Time Frame: Completed at baseline (T0)
|
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.
|
Completed at baseline (T0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: Baseline (T0) before intervention
|
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
|
Baseline (T0) before intervention
|
Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: one-week follow-up (T1)
|
7-item measure of generalized anxiety; scores range from 0 to 21 with higher scores indicating more anxiety.
|
one-week follow-up (T1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2022
Primary Completion (Actual)
May 4, 2022
Study Completion (Actual)
May 4, 2022
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 22, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021NOV10-DAI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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