Consent to Participate in Screening Survey
Identification of Investigator
You are invited to participate in a research study, entitled "Development of Attention Bias Modification for Depression." The study is being conducted by Christopher Beevers, Ph.D., Psychology Department, of The University of Texas at Austin, 305 E. 23rd St, CLA 4.528, Austin, TX, 78712, 512-232-3706, beevers@utexas.edu, and David Schnyer, Ph.D., Psychology Department, of The University of Texas at Austin, 108 Dean Keeton St, SEA 5.246, Austin, TX 78712, 512-475-8499, schnyer@utexas.edu.
Purpose of Study
The purpose of this research study is to examine the development of an attention bias modification (ABM) intervention designed to target and reduce negative attention bias and thereby reduce symptoms of depression. Your participation in the study will contribute to a better understanding of the role of negative attention bias in depression, and how specifically targeting and reducing negative attention bias can affect depressive symptoms. You are free to contact the investigator at the above address and phone number to discuss the study. You must be at least 18 years old to participate.
If you agree to participate:
-First, you will complete an online questionnaire to determine your eligibility in the research
study. The questionnaire will take approximately 10 minutes of your time.
-If you are eligible based on this questionnaire, a researcher will contact you via phone to conduct
a phone screening to further determine your eligibility. The phone interview will be audio
recorded for quality control and will take approximately 30 minutes of your time.
-If you are eligible based on the questionnaire and the phone screening, you will come into the lab for a baseline assessment. At the baseline assessment, you will complete questionnaires and computer tasks (including eye tracking tasks) to further determine your eligibility. If you are eligible based on the questionnaires and the eye tracking tasks, you will also complete an fMRI (functional magnetic resonance imaging) scan later in the week. The baseline assessment will take up to two and a half hours of your time. The baseline fMRI scanning session will take approximately two and a half hours of your time.
-You will then be randomized to a condition of the study. In two conditions, you will complete twice per week in-clinic ABM sessions and three times per week at-home attention bias modification (ABM) during a one-month training period. Each in-lab ABM session will take approximately 25 minutes of your time. Each at-home session will take approximately 6 minutes of your time. Both in-clinic and at-home ABM sessions will consist of completing the computerized training program in full. Multiple breaks are included during the in-lab training sessions.
-In all conditions, you will also complete in-clinic questionnaires, clinician-administered interviews, and computer tasks once per week, and fMRI assessments once every other week for one month. These assessments may take up to two and a half hours of your time per week.
-If your baseline fMRI assessment is not usable (e.g., not able to schedule due to scheduling conflicts, significant image artifacts, excessive movement), we may discontinue collection of the fMRI assessments.
-In all conditions, you may complete short questions by mobile phone on a daily basis, as well enable passive recording of mobile data (i.e., device usage, weather data, ambient noise, geographic area, non-identified communication patterns [i.e., we will not collect names or phone numbers], and accelerometry). This data will be collected over the course of your participation and is optional.
-You will be compensated $20 per assessment visit, up to $50 for collection of mobile data, and $50 per attended fMRI assessment for a total of up to $300.
Risks/Benefits/Confidentiality of Data
There are no direct benefits to participating in this study. One possible benefit of participation is that ABM could help to improve negative attention bias and in turn reduce depression severity. More generally, your participation may also contribute to the field of research on ABM, negative attention bias, and treatment mechanisms for depression. Such research helps us understand how/if negative attention
bias maintains depression, improving the ability for clinicians and researchers to treat someone with this disorder and thereby improve overall clinical care.
This research study may involve risks that are currently unforeseeable. There are some possible risks associated with participating in the study. Some of the questions on the questionnaires are personal and may be sensitive. You may choose to skip or not answer a question that you do not wish to answer. It is unlikely, but there is a chance that you may become emotionally upset by some of these questions. In addition, the computer tasks may be frustrating or difficult and this may cause you to be upset emotionally. We will make every effort to minimize any discomfort you may feel during this process. If you continue to feel emotional discomfort, we cannot provide any treatment, but we can give you a list of references that you can contact. Please don't hesitate to alert the researchers if you are uncomfortable. There is a risk of potential breach of confidentiality. However, no data form will ever have your name on it and all records will be kept in locked files and secure servers, only available to researcher personnel trained in confidentiality and human participant protection guidelines. Moreover, all data will only contain a numeric code, all assessment procedures will be closely supervised, and all staff will be trained and reminded of the need to keep all information confidential.
There are no known or foreseeable risks associated with conventional structural and functional MRI scanning procedures, except for those people who have electrically, magnetically or mechanically activated implants or those who have intracerebral vascular clips. The risks of scanning to an unborn fetus are unknown, and therefore if you are pregnant or think you could be pregnant you are not eligible to participate. We will try to minimize your discomfort while in the MR machine, but you will hear a number of loud sounds and you may experience feelings of claustrophobia or anxiety during the MRI scan. You can indicate at any time that you would like to end the procedure.
There will be no costs for participating, nor will you directly benefit from participating. Your name and email address will be kept during the data collection phase for contact purposes only. A limited number of research team members will have access to the data during data collection. Identifying information will be stripped from the final dataset.
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 anyway. If you do not want to participate either simply stop participating or close the browser window.
If you do not want to receive any more reminders, you may email us at mdl@utexas.edu.
Contacts
If you have any questions about the study or need to update your email address contact the researcher Christopher Beevers at 512-232-3706 or send an email to beevers@utexas.edu, or David Schnyer at 512-475-8499 or send an email to schnyer@utexas.edu. This study has been reviewed by The University of Texas at Austin Institutional Review Board and the study number is 2016-06-0034.
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) 471-8871 or email at orsc@uts.cc.utexas.edu.
If you agree to participate, click "Yes" below.
Thank you.
Please print a copy of this document for your records.