Consent for Screening

Consent to Participate in Online Research

Identification of Investigator and Purpose of Study
You are invited to participate in a research study, entitled "Evaluation of a Gamified Therapeutic Mobile App for Depression Symptoms." This consent form will help you choose whether or not to participate in the study. Feel free to ask if anything is not clear in this consent form.

The study is being conducted by Dr. Christopher Beevers through the Mood Disorders Laboratory at the University of Texas at Austin.

Preferred method of contact: mdl@utexas.edu
Institute for Mental Health Research
Department of Psychology
108 E Dean Keeton St
Austin, TX 78712
(512) 232-4750

Consent to Participate in Screening Survey:

The purpose of this survey is to determine whether you are eligible for a research study that test the efficacy of a mental health app as a treatment for symptoms of depression. Feel free to contact the research team at mdl@utexas.edu if you have any questions about this study or the consent form.

 

Below is the procedure for the screening and eligibility procedure for this study:

1. After this consent form, we will invite you to complete general demographics, mood surveys, and screening questionnaires so we can assess whether it looks like you're a good candidate for the study. You will not be compensated for completing this screening survey. If you are not eligible, you should be notified by the end of the survey, or we will follow up by email. Please note that we are unable to provide individualized feedback on why people are not eligible for the study.

2. If you look potentially eligible, we will review your screening questionnaire within a few days of completion. We will then send you a link to complete a baseline assessment for the study within 2 weeks of your screening survey. This assessment should take about 30 minutes and will consist of a few questionnaires and computer tasks. We will review this assessment as soon as possible (i.e. within a few days at most) and will email you to inform you of your eligibility status.

3. If you are eligible, we will invite you to participate in the study. If you want to participate, we will send you another consent form and set up a Tech Onboarding zoom call with one of our research assistants. During this 15-20 minute call, the research assistant will verify your identity, show you how to download the app, login to the app, and officially enroll you in the study.

Please note that because of the dynamic nature of some of the eligibility criteria we are assessing, we try to keep the turnaround window between steps 1 and 2, and 2 and 3 within two weeks. If more than two weeks pass between steps, we might ask you to restart the eligibility process to confirm that you are still a good fit for this study.




Below is further information about the study you are completing a screening form for.

Study Overview

This research study is a randomized controlled trial testing the efficacy of a mental health app as a treatment for symptoms of depression. The app uses game-based training exercises designed to target key emotional and attentional patterns associated with depression. If you choose to participate, you will be randomly assigned to one of two versions of the app: a version that includes these training exercises at a high frequency and a version that includes them at a lower frequency. You will not know which version you are assigned to.

Your participation in the study will contribute to a better understanding of the cognitive mechanisms involved in depression, and how they might be impacted by a digital therapeutic app. You are free to contact the investigator at the above email address to discuss the study. You must be at least 18 years old to participate.

If you agree to participate, below is the overall time commitment of the study:

At the beginning of the study, you will be asked to schedule a 15-minute tech onboarding Zoom call with a research assistant. They will walk you through downloading and registering the app and troubleshoot any technology issues.
Once daily, you will be sent a very brief (~5 question) survey to your phone to ask about your mood symptoms.
Four times a week, you will be asked to complete 1 session of game play on the app that will take approximately 14 minutes each. The study will last for 4 weeks (4 times per week x 4 weeks = 16 sessions of game play total).
Once weekly, you will be asked to fill out a questionnaire about your mood and symptoms, as well as complete computer tasks in which stimuli (e.g. words, or images of faces, scenes, or objects) will be presented and you will respond according to the instructions.

Weekly time commitment: ~ 56 minutes of game play, 30 minutes of assessment total for the week (for 4 weeks). You will be compensated for the assessments (see Compensation below).

Benefits/Risks/Confidentiality of Data

You may or may not benefit from this study. It is possible that you may experience some improvement in depressive symptoms from participating.

Possible risks associated with this study include emotional discomfort, as some of the survey questions are of a personal nature and some of the stimuli are negative and therefore may make some participants uncomfortable. You may skip any questions that make you uncomfortable. You may contact the researchers with the contact information listed on this sheet to request mental health resources if you wish. There will be no cost to you for participating.

Please note that while we check our email during normal business hours (9 am - 5 pm CST), we do not monitor our email constantly. If you are experiencing feelings of discomfort and wish to discuss them or seek help, we encourage you to either call a local counseling center, call the National Suicide Prevention Lifeline by dialing 9-8-8, or go to your nearest emergency room.

In the case that contact is made with us and your discomfort is related to a personal concern that arose through participation and you are contacting us because you are in distress, we will be happy to briefly discuss your experience at mdl@utexas.edu. If your distress endures, we can refer you to several supportive resources, depending on the specific nature of your concern.

If you consent and elect to continue with this screening survey, REDCap will automatically collect your IP address. We do not use this for data; it is only used for data security purposes. Your name and email address will be kept during the data collection phase by our study personnel for study support and tracking purposes only. It is possible, but very unlikely, that a breach of confidentiality could occur. We will minimize this risk by storing data securely, identifying data only with a numeric code, and only allowing research personnel to access the research. A limited number of research team members will have access to the final data during data collection. Identifying information will be stripped from the final dataset.

For our records and to be able to pay you for the assessments, we do need to verify your identity. During the tech onboarding call, we will ask you to hold up a photo ID to the camera so we can verify your name and date of birth. We only need to confirm your identity with our records, and will not record or photograph your ID.

The app (Therapeutic Mobile Game) collects your contact information (email address) and technical data. Your email is used by the app to provide you with a verification code to register, to send you notifications, and for technical support for the clinical study. We also use an online behavioral experiment platform, Gorilla, for conducting part of the study. Gorilla collects your email address to send you reminders to complete the weekly assessments.

The technical data is not itself personal data and is associated and affiliated with the contact information you provide (i.e. your email address). Technical data includes, for example, information about your app usage (e.g., when a Study App was first launched), app version and installation ID, device identifier, and technical data about your device, such as operating system and model. The non-personal technical information may be used for purposes including, but not limited to:

To conduct and support the Study
To develop therapeutic and health-related products, including improving the usability of the application

WiseDTx may share your information with companies who provide services for or on behalf of the Study App such as data storage or interpretation of de-identified analytical data. These companies are obligated to protect your information. Detailed information about the apps privacy policies can be found here: https://wisedtx.com/legal/. Additionally, there may be tools used as part of this study that will collect specific digital data about participants' use of the app (i.e., when and how long the app was used, speed of reactions during gameplay in the app), such as those from Wise Therapeutics, Inc., the creator of the app. This data is crucial for monitoring participant TMG app use during the 30-Day Treatment Phase and will allow research assistants to identify participants who may need reminders to complete the four 12-minute TMG sessions per week to maintain study enrollment. This data will only be accessed by study-approved research personnel.

To make the most of these valuable data resulting from your participation, we will make deidentified data available to the research community. In these cases, the data will contain no identifying information that could associate it with you, or with your participation in any study.

There are certain situations in which we may break confidentiality. If during the study we learn about child neglect, child or elder abuse, or that someone is a clear, serious, and direct harm to self or others, we may report the information to appropriate authorities, including the police, the Texas Department of Family and Protective Services (or relevant state agency if outside of Texas), and/or an emergency medical facility.

Texas Education Code, Chapter 51, Subchapters E-2 and E-3, requires reporting incidents of sexual assault, sexual harassment, dating violence, or stalking committed by or against a person who was a student enrolled at or an employee of UT Austin at the time of the incident. However, the researchers working on this study have been designated as confidential employees. This means that if we learn about any incidents of sexual assault, sexual harassment, dating violence, or stalking, we are only required to report the type of incident reported and the date we learn about the incident. We will not report any information that could identify you.

If it becomes necessary for the Institutional Review Board to review the study records, information that can be linked to you will be protected to the extent permitted by law. Your research records will not be released without your consent unless required by law or a court order. The data resulting from your participation may be made available to other researchers in the future for research purposes not detailed within this consent form. In these cases, the data will contain no identifying information that could associate it with you, or with your participation in any study

A description of this study will be available on http://www.ClinicalTrials.gov as required by U.S. law. This web site will not include information that can identify you.  At most, the web site will include a summary of the results.  You can search this web site at any time.

Compensation

Please initial here to indicate you understand there is no compensation for completing this screening survey. The description of compensation below only applies to the study you are completing the screening survey for.

There is no compensation for using the app. Compensation is offered in the form of gift cards only for completing the weekly assessments and will depend on how participants engage with the study. You will receive $5 for each weekly assessment you complete. However, you can receive additional bonuses for completing multiple assessments.

- At the end of the study, if you have completed 2 assessments total, you will receive a $5 bonus ($5 x 2 assessments = $10 + $5 bonus = $15).
- If you have completed 3 assessments total, you will receive a $10 bonus. ($5 x 3 assessments = $15 + $10 bonus = $25).
- If you complete four assessments, you will receive a $15 bonus. ($5 x 4 assessments = $20 + $15 bonus = $45).
- If you complete all five assessments, you will receive a $25 bonus. ($5 x 5 assessments = $25 + $25 bonus = $50).

Thus, the maximum amount someone can earn through the study is $50 ($5 x 5 assessments and a $25 bonus for completing all 5).

If you are an undergraduate student and want to receive course credit through the SONA 301 Research Pool, you will receive course credit instead of financial compensation. You will receive one hour of credit for each week you complete, and your course credit will be prorated for the amount of time you spend on the study. For instance, if you complete the study through week 4, you can earn 5 credit hours. If you only complete the baseline assessment, you will receive only 1 credit hour. If you do not want to complete the study, you may sign up for other studies or complete a research paper that involves a similar amount of time and effort to fulfill your class requirements. Discontinuing this study will have no bearing on your relationship with the University of Texas.

Participation or Withdrawal

Your participation in this study is voluntary. You may decline to answer any question and you have the right to withdraw from participation at any time. Withdrawal will not affect your relationship with The University of Texas in any way. If you do not want to participate either simply stop participating or contact a study coordinator at mdl@utexas.edu.

To ensure that we can test the efficacy of this intervention, we require that participants receive a minimum amount of training sessions in this study. If you miss 4 or more of the total 16 trainings, you will be withdrawn from the study. At this point, you will not be able to complete additional trainings or additional assessments for compensation.

Contacts

If you have any questions about the study or need to update your email address contact the researcher at (512) 232- 4750 or send an email to mdl@utexas.edu. This study has been reviewed by The University of Texas at Austin Institutional Review Board and the study number is STUDY00003315.

Questions about your rights as a research participant.
If you have questions about your rights or are dissatisfied at any time with any part of this study, you can contact, anonymously if you wish, the Institutional Review Board by phone at (512) 232-1543 or email at irb@austin.utexas.edu.

Please print a copy of this document for your records.