UNIVERSITY OF CALIFORNIA SAN FRANCISCO
ASSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: TARA (Training of Attention and emotion Regulation in Adolescents)
This is a research study to test if a 12-session group program can help young people (age 14-18) with depression feel better. Larissa Duncan, Ph.D. and Frederick Hecht, M.D. at the UCSF Osher Center for Integrative Medicine and Eva Henje Blom, M.D., Ph.D. and Tony Yang, M.D., Ph.D. from the Langley Porter Psychiatric Hospital and Clinic at UCSF are doing this study. The study researchers will explain this study to you.
Research studies include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the researchers. You should only agree to participate in the study if you really want to.
You are being asked to take part in this study because you have some symptoms of depression.
Why is this study being done?
The purpose of this study is to see whether a new 12-session group program can help young people with depression feel better. The study investigators hope this program will help young people with depression get better but they don’t know if it will for sure. That’s why they are doing the study.
The study is being paid for by a grant from UCSF.
How many people will take part in this study?
About 36 teenagers aged 14-18 years old will take part in the study.
What will happen if I take part in this research study?
If you agree, and your parent gives permission for you to participate, the following procedures will occur:
First, you will need to have the following “screening” tests or procedures to find out if you can participate in the study:
Phone screening: You and your parent/guardian will speak to a study staff member to learn about the study and see if you might be interested and eligible to participate. You and your parent will be asked questions about your age and grade in school, and your current and past mental health history. If it appears that you might be eligible to participate and you are interested, you will be invited to schedule an in-person visit to enroll in the study for further screening and testing.
In-person screening: At this visit, the researcher will first review this consent form with you and your parent/guardian. If you wish to participate, and your parent gives permission for you to participate, you both will sign this form. The researcher will ask you and/or your parent questions and will ask you to complete some questionnaires on a computer. The questions will be about your thoughts and feelings, use of alcohol and drugs, developmental status, and your school, psychological, medical, and family history. You will be asked some questions about color blindness, vision, handedness, and metal implants to see if you can have a brain scan as part of the study. You will also do two computerized tests of memory and attention.
Your parent/guardian will be asked to stay in the room for some parts of the interview, so that they can help you if you are unsure of the answers. Your parent will be asked to answer some questions about you. When you are filling out forms on the computer, the researchers will be nearby and can answer any questions or help you with any problems you have. You can choose not to answer certain questions if you wish. The researcher will make a sound recording of some parts of the interview so that a study doctor can review it if needed. The researcher will always tell you before turning on the recorder.
This visit will take approximately 2-4 hours. You can take breaks at any time during the visit. You may be able to complete some parts of the interview over the phone from home after the visit or at a separate time. In special circumstances, your parent/guardian may be able to complete the consent process and initial steps over the phone.
If these screening tests show that you can be in the main part of the study, and you choose to continue, this is what will happen next:
1. Baseline visit: This visit will take approximately 1hour. At this visit, you will do the following:
a. You will complete personality, mood, and behavior questionnaires on a computer. The questionnaires will take approximately 45-60 minutes. You may be able to complete these questionnaires at home over the internet. Study staff will be nearby and available to help if you have questions or need help.
2. Magnetic resonance Imaging (MRI) of the head: 20 participants will have a separate visit for a brain scan two times during the study—at the beginning of the study, and again 3 months later. You may be asked to complete a brain scan. If you agree, you will go to the UCSF’s Mission Bay campus for the scan. This visit will take approximately 2-3 hours.
Magnetic Resonance Imaging (MRI) will be done on your head. This will involve your lying quietly inside the center of a large, doughnut shaped magnet for approximately 1-2 hours. Your head will be placed in a special, helmet-like “head-holder” to help you keep your head still. We will place a Velcro belt around your stomach and also some plastic tubing just inside your nose so that we can measure your breathing. We will also place a rubber ring on your finger to measure your heart rate.
You will be made as comfortable as possible by padding your neck, shoulders, head, and knees. During the scan, the machine takes pictures of your brain. You will see pictures of a variety of things, including: humans, human faces with different facial expressions, animals, landscapes, symbols, letters, geometric shapes like triangles or squares, and other objects. You may also see different words that you will read silently while inside the scanner. You may feel different water temperatures on the surface of the skin on your arm. You can take breaks at any time during the scan. After the scan, you may be asked to rate the faces you saw while inside the scanner.
3. Randomization: After these assessments are completed you will be randomly assigned to one of two groups. One group will simply continue with their current depression treatment with their doctor or therapist (i.e. Standard treatment group). The other group will receive a new group treatment that will be offered in addition to continuing their current depression treatment with their doctor or therapist (TARA treatment group).
Twice as many people will be assigned to the TARA treatment group as to the standard treatment group. This means you will be twice as likely to be assigned to the TARA group as to the standard treatment group. The decision is random--neither study staff nor you or your parent/guardian will make the choice. Regardless of which group you are assigned to, you will continue in your regular depression treatment as usual with your doctor or therapist, and will return for study follow-up visits at 3 and 6 months.
4. Blood drawing (venipuncture): Regardless of which group you are assigned to, you will be asked to come in to give a blood sample for laboratory tests before the 12 week treatment phase and after the 12 week treatment phase (a total of two times). Approximately 2 tablespoons of blood will be drawn each time by inserting a needle into a vein in your arm. Each blood draw visit will take about 10 minutes.
5. Treatment phase:
For those in the Standard treatment group: If you are assigned to be in the Standard treatment group, you will continue your regular depression treatment with your doctor or therapist as usual. You will also complete some short questionnaires about how you are doing and feeling during this 2-3 month period.
For those in the TARA treatment group: If you are assigned to the TARA treatment group you will continue your regular depression treatment and also participate in the TARA program for 12 sessions as follows:
a. Group classes: You will participate in the TARA treatment classes for 12 sessions. In the class, you will learn and practice skills to help you feel calm and relaxed and to control your emotions and your attention. You will also learn and talk about stress, anxiety and depression, as well as what is most important to you. You will learn how the brain functions and how you can increase your sense of well-being. You may do some easy yoga poses. You will have one-two classes per week over 2-3 months. There are 12 classes total. Classes will be 90 to 120 minutes. There will be about 8-14 other teenagers in the class with you. Study staff will go over the exact dates of the classes with you. It is understandable that you may have a schedule conflict for one or two of the classes, but you should only participate if you can attend nearly all of the classes.
b. Audiotaping: An audio recorder will be placed in front of the class, near the teacher. You will have the option to stop the recorder if you don´t want what you say to be recorded. After the class, someone will type into a computer a transcription of what’s on the recording and will remove any mention of names. The recordings will be destroyed when they have been transcribed and the study is completed.
c. Home practice: You will be asked to practice some of the skills that you learn in the class at home for about 10-15 minutes every day. You will receive recorded instructions on a CD; if you prefer, you can listen to the instructions by downloading the recording to an mp3 player or computer.
d. Weekly Questionnaires: Each week of the classes, you will complete a short questionnaire about your opinions about the classes and which parts were most helpful. You will also complete some short questionnaires about how you are doing and feeling. At the end of the 12-session program, you will be asked to participate in a focus group with other class members to discuss your class experience. The purpose of these procedures is to get your feedback about the classes so we can make them better.
6. 3 month assessment visit: After the 12 session intervention phase is complete, you will come back to repeat some of the questionnaires and interviews that were done before the classes. At this 1-2 hour visit, the following procedures, previously completed at the baseline visits (and described more fully in that section) will be completed at this visit: interview about your thoughts and feelings, questionnaires on the computer, and computerized tests of memory and attention. You may be able to complete some of the questionnaires over the internet from home.
7. 3 month MRI: If you had a brain scan at the beginning of the study, you will be asked to do this again. The procedure will be the same as the first time. The visit will be at UCSF Mission Bay and will last approximately 2-3 hours.
8. 6 month assessment visit: Approximately 6 months after the start of the study, you will come back for a final visit. Similar to the 3 month visit, you will be asked questions about your mood and health, complete questionnaires on a computer, do some computerized tests of memory and attention. This visit will last 1-2 hours.
9. For those in the Standard treatment group: After you have completed the 6 month assessment visit, and if preliminary data analysis of the intervention shows it to be effective, you will be offered an optional 4 hour half day workshop that will included some of the skills taught in TARA. You may learn and practice skills to help you feel calm and relaxed, and to control your emotions and attention. You will learn how you can increase your sense of well-being and may do some easy yoga poses. Study staff will go over the date of this workshop with you.
If you move out of the Bay Area or otherwise are unable to come for a 3 or 6 month study visit, study staff will work with you to complete questionnaires online and/or by phone.
Time commitment and Location: If you are in the TARA treatment group, you will spend about 43-48 hours over 8 months on study activities (7-12 hours on assessments over 8 months, and 36 hours on the group intervention over 3 months). If you are in the standard treatment group, you will spend about 7-12 hours over the 8 month period on assessments. Study visits and classes may take place at an Edgewood clinic or at UCSF (Osher Center for Integrative Medicine or Langley Porter Psychiatric Institute). In special circumstances, it may be possible to complete study visits at your home. Brain scan visits will take place at the UCSF Mission Bay campus.
How long will I be in the study?
You will be in the study for approximately 8 months, including the time from screening to 6-month visit.
Can I stop being in the study?
Yes. You can decide to stop at any time, for any reason. Just tell the study researcher or staff person right away. Also the study researchers may stop you from continuing the study he/she if they think it is best for you to stop, or if you do not follow the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the study?
· Questionnaires, interviews and self-assessment: Some of the questions may make you uncomfortable. You are free to decline to answer any questions. You may feel tired, frustrated or bored when filling out the forms.
· Randomization: You will be assigned to a group by chance. You may not get the group you prefer. Also, the group you are assigned to may prove to be less effective than the other group or than other available programs. This will not be known until after the study is completed and the data have been analyzed.
· Venipuncture: The risks of drawing blood include temporary discomfort from the needle stick, localized bleeding and bruising, and rarely, fainting or localized infection.