An individual lies in this specialized heating tent for approximately 2 hours while the heat levels, similar to a fever, are closely monitored.
The Study
This study will take place over eight weeks at the University of Arizona Campus and will involve about 10 visits.
Study Screening
Our screening involves a two step process. The first step is via phone, the second step is an in-clinic visit.
Phone Screening:
- Phone screening with a member of our staff (takes between 10 and 30 minutes to complete). You will be asked questions about your depression and your medical and health history.
In-Clinic Screening:
If you pass the phone screening, we will schedule an in-clinic screening visit which will take between 2 and 3 hours. During this visit you will:
- Have an in-depth interview with study personnel to learn more about your depression
- Complete several questionnaires
- Have a blood draw and electrocardiogram to make sure you are medically healthy
- Have a routine urine test to ensure that you are not pregnant (for women) and/or are not taking any recreational drugs that could interfere with the results of the study.
- If you screen eligible, five days following your in-clinic screening, we will send you an on-line questionnaire to fill out.
Based on the results of your interview, questionnaire responses and lab tests, we will determine if you are eligible to participate in the study. If you are eligible, we will schedule your first study visit.
Study Visits
Visit 1- Device Weekend #1:
If you qualify for the study, we will schedule you for your first study visit, on a Friday. At this visit you will receive the three study devices you will wear over the weekend.
At this visit you will be given a digital recorder and asked to wear the recorder for one weekend. This recorder, called the EAR (short for ‘Electronically Activated Recorder’), will measure how you relate to other people in your environment and how you spend your time in general (see picture).
The EAR Recording Device
You will also be asked to swallow a small pill and wear a small device on your chest (via a vest under your shirt). Together, these devices will measure your core body temperature over the course of the weekend. The pill will automatically pass through your body about 72 hours after you take it (see pictures below).
The Core Body Temperature the Vest for the Core Body Temperature Recording Pill
You will also be asked to wear a special type of wrist watch (an actigraph) that will record your physical activity during the day and will provide information about your sleep at night (see left).
The Actigraph Watch
Visit 2 - Intervention Day:
On the Monday after your first visit, you will return to the clinic for a full-day of assessments and the infrared treatment session. This visit will last from 8am until 5pm. During the morning you will have interviews, fill out some questionnaires and have a few non-invasive assessments. The heating session will begin at 1pm and will last 2 hours and 20 minutes.
Assessments that will take place in the morning include:
- A fasting blood draw and urine test
- Interviews by the staff
- Questionnaires
- Body fat composition testing
- Heart rate variability and skin conductivity testing (non-invasive)
The heating session will take place in the afternoon.
- During the heating session, you will be lying on a standard hospital stretcher, enclosed by a heating tent (see picture above).
- Different people respond differently to the infrared treatment, but your body temperature may rise as high as 38.5 C (101.3 F).
- Your vital signs will be continuously monitored, and the infrared session will be recorded both for safety and for investigators to examine your behavior during the infrared session.
- You will be asked to answer some questions during the session.
- Following the session you will again fill out some questionnaires and have a final blood draw.
Visits 3 and 6 - Device Weekend #2 and Device Weekend #3:
You will come to the clinic to pick up the three study devices you will wear over the weekend (see information above).
Visits 4 and 7 - Week 1 and Week 4 Follow-Ups:
These visits occur on Mondays, one week and four weeks following the Intervention Day Visit. On these days you will again come to the clinic. During these visits you will:
- Have a fasting blood draw and urine test
- Be interviewed by the staff
- Complete several questionnaires
- Have your body fat composition tested
- Have your heart rate variability and skin conductivity levels tested (non-invasive)
Visits 5 and 8 - Week 2 and Week 6 Follow-ups:
These visits occur on Mondays, two and six weeks following the Intervention Day Visit. You will come to the clinic and will:
- Be interviewed by the staff
- Complete several questionnaires
All participants who complete the study will be offered the option to complete an active treatment session in an open fashion. This means that you will receive the full heat, the intervention we are testing, regardless of the arm you were originally randomized to. This will allow every study participant the option of receiving the full heat at least once during the study. If you decide to participate in the open treatment, we will follow you up 1 week after your open treatment.
3 Month Follow-up:
Approximately 3 months after your last heating session, you will be asked to come back to the clinic and fill out some questionnaires and have an interview with our staff to see how you have been feeling since the last time you came to the clinic. We will also ask you some quesitons about any changes in your life that have occurred since completing the study, such as your depression levels and if you have started any new treatments.