Study Overview
This research study is a randomized controlled trial testing the efficacy of a mental health apps as a treatment for symptoms of depression. The apps use 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 three versions of the app: two versions of the app include the active ingredients thought to reduce depression and one version does not include these active ingredients. You will not know which version you are assigned to (nor does the research assistant). This study involves an investigational mental health app, which means that the study app is still being investigated in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
Your participation in the study may 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 2-hour, in-person, onboarding appointment at the University of Texas at Austin with a research assistant. You will complete some laboratory tasks, including an eye tracking assessment, an interview about current and past psychiatric symptoms, and then they will walk you through downloading and registering the app and troubleshoot any technology issues.
- Four times a week, you will be asked to complete, at a location of your choosing, 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). We are testing three different versions of this cognitive training program: two versions include the active ingredients thought to reduce depression and one version does not include these active ingredients.
- Once weekly, you will be asked to return to the University of Texas at Austin for one hour to complete laboratory 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. These assessments will also include eye tracking.
- After this four-week period, to assess how long the potential benefits of completing the app last, you will complete symptom assessments (15 minutes each) at a location of your choosing three times during a 6-month follow-up period.
Time commitment: ~ 56 minutes of game play + 60 minutes of assessment per week for 4 weeks, followed by 3 monthly assessments (15 minutes each) across a 6-month follow-up period. You will be compensated for all the assessments (see Compensation below). The total time commitment is approximately 8 hours across six months.
For our records and to be able to pay you for the assessments, we do need to verify your identity. During the initial in-person assessment, we will ask you to present a photo ID 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. We will do this for the screening survey and the full study.
Risks or Discomforts of the Research
Possible risks associated with this study include breach of confidentiality or 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.
Benefits of the Research
Although you will not directly benefit by completing this screening survey, society may benefit from this study overall by providing a better understanding of depression. If you are eligible for this study and consent to participating, you may or may not benefit by experiencing improvement in depression symptoms depending on your response to the cognitive training exercises. At the conclusion of the study, we will provide additional digital intervention options to anyone who is interested.
Privacy and Confidentiality Protections
UT Austin has established secure research databases and computer systems to store information and to help with monitoring and oversight of research. Your information may be kept in these databases but are only accessible to individuals working on this study or authorized individuals who have access for specific research related tasks.
Identifiable information in these databases is not released outside of UT Austin unless stated in this consent or required by law. Although results of this research may be presented at meetings or in publications, identifiable personal information about participants will not be disclosed.
Personal information about you might be shared with or copied by authorized representatives from the following organizations for the purposes of managing, monitoring, and overseeing this study:
· The study sponsor (National Institutes of Health) and/or representative of the sponsor;
· Representatives of UT Austin and the UT Austin Institutional Review Board;
· Officials of the Department of Health and Human Services or the Federal Food and Drug Administration.
Under certain situations, 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.
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.
To help protect your privacy, this research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide information, documents, or samples that may identify you as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.
Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers, or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.
Research Data Management
In general, we will not give you any individual results from the study. Research data will be kept for at least 3 years after study completion. During this time, your name and other information that can directly identify you will be kept secure and stored separately from the research data collected as part of the project.
Audio recordings of interviews will be transcribed with all identifiers removed, and the recordings will be destroyed at the earliest opportunity.
In the future, identifiers might be removed from the information you provide in this study, and after that removal, the information could be used for other research studies by this study team or another researcher without asking you for additional consent.
Compensation
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 assessments and will depend on how participants engage with the study. If enrolled into the study, you will receive $25 for each of the five weekly assessments you complete ($125). After these assessments, there will be three symptom and functioning follow-up assessments. These will be completed remotely. You will receive $15 per assessment (which we expect will take approximately 15 minutes each) with completion bonuses increasing for each additional follow-up assessment (i.e., $10, $15, $30) for a total of $100 if all the follow-up assessments are completed. Total compensation will be $225 for all assessment visits. Discontinuing this study will have no bearing on your relationship with the University of Texas. If you are determined ineligible to participate further in the study during your first in-person visit, you may be compensated up to $15. Compensation for in-person screening starts at $5 and increases based on the amount of time and effort spent during the screening process.
· 20-30 minutes spent on in-person screening = $5
· 30-45 minutes spent on in-person screening = $10
· 45-60 minutes spent on in-person screening = $15