The University of Arizona is looking for individuals interested in participating in a study designed to test a novel, non-medication-based, treatment for Major Depression. This treatment will involve receiving regular, weekly psychotherapy sessions at the University of Arizona’s Psychology Clinic, filling out questionnaires and having a single session of one of two intensities of whole body hyperthermia (WBH) while simultaneously receiving psychotherapy. WBH involves laying in a special device that delivers safe infrared heating to the body. The purpose of this study is to test whether one session of whole-body infrared heating can enhance psychotherapy treatment.
An individual lies in this specialized heating tent for approximately 2 hours while the heat levels, similar to a fever, are closely monitored.
This study is in Tucson, AZ, and the majority of study visits will happen at the UA’s Psychology Clinic. The WBH + Psychotherapy session will occur at the UMC in Tucson.
Compensation will be provided for the WBH session and participants’ psychotherapy sessions will be paid for.
There will be different groups of people enrolled into this study:
1. One group will have weekly psychotherapy and complete study questionnaires and audio recordings
2. A second group will have weekly psychotherapy sessions, complete the study questionnaires and audio recordings, and have one WBH session while completing a psychotherapy session. This group of subjects will be randomized to receive one of two levels of heat during this session. The different levels of heat are explained below:
- The highest level of heat available for the WBH Intervention; which raises core body temperature to approximately 101.3 degrees F.
- The lower heat group will go through all of the same study procedures; however they will not receive the highest level of heat.
You may be eligible if you meet the following general entry requirements:
- Currently between the ages of 18-65
- Currently experiencing depression for at least four weeks
- Not currently taking any antidepressants
- Medically healthy
You cannot participate if you:
- Are currently taking antidepressants
- Have diabetes
- Have silicone or breast implants
- Have bipolar 1 disorder
- Have a personality disorder
- Have schizophrenia
- Currently have a substance abuse or drinking problem
- Have had cancer in the past five years
- Are claustrophobic
If you meet these criteria, you may be eligible to participate in this study. Please fill out the form below, or contact our staff at: 520-314-7492 or send us an email.
More detailed information is provided below.
The Study
This study will take place over eight to twelve weeks at the University of Arizona Campus.
Study Screening
Our screening involves a three-step process. The first step is via phone with the Psychology Clinic to determine if you are eligible for psychotherapy treatment in their clinic. If you are, and you are interested in participating in the study, you will then be screened via phone by the staff at the University of Arizona’s Department of Psychiatry. If you are eligible based on the phone screening, you will then be asked to come to the University of Arizona’s Medical Center (UMC) for an in-clinic screening.
Phone Screening with the Psychology Department:
- Phone screening with a member of the Psychology Clinic staff (takes between 10 and 30 minutes to complete). You will be asked questions about your depression and your medical and health history.
Phone Screening with the Psychology Department:
- Phone screening with a member of the University of Arizona’s Department of Psychiatry (takes between 10 and 30 minutes to complete). You will be asked questions about your medical and health history to determine if you are potentially eligible to receive WBH therapy.
- If you are not eligible to receive the WBH therapy, you can still participate in this study by taking part in psychotherapy and filling out questionnaires.
In-Clinic Screening:
If you pass both of the phone screenings, we will schedule an in-clinic screening visit for you which will take place at the UMC. This visit will take about 1 hour. During this visit you will:
- Have a blood draw to make sure you are medically healthy
- Have an electrocardiogram to make sure your heart is 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.
Based on the results of your lab tests, we will determine if you are eligible to participate in the study. If you are eligible, you will fill out questionnaires and have weekly psychotherapy sessions recorded. Your fourth psychotherapy session will take place at UMC while you are undergoing the WBH or WBH control intervention.
Study Visits – For Those Electing to Participate in the Psychotherapy + Questionnaire Only Portion
1st Psychotherapy Session:
If you qualify for the study, we will schedule you for your first psychotherapy session.
If you wish to participate in only the questionnaire portion of the study, at your first psychotherapy session you will be asked to arrive 1 hour early so that you can read and sign the informed consent form and fill out the study questionnaires. Following this, you will have your regular psychotherapy session which will be recorded. Your therapist will schedule you for your subsequent appointments.
All Subsequent Psychotherapy Sessions:
You will be asked to arrive 30 minutes early so that you can fill out the study questionnaires. Following this, you will have your regular psychotherapy session which will be recorded.
Study Visits – For Those Electing to Participate in the WBH + Psychotherapy Sessions
1st - 3rd and 5th-12th Psychotherapy Sessions:
If you qualify for the study, including the WBH portion, we will schedule you for your first psychotherapy session.
You will be asked to arrive 30 minutes early so that you can fill out the study questionnaires. Following this, you will have your regular psychotherapy session which will be recorded. Your therapist will schedule you for your subsequent appointments.
4th Psychotherapy Session:
During this session, you will receive WBH or WBH control intervention while undergoing psychotherapy at the same time. This visit will take place at the UMC facility.
This visit will take about four hours of your time. Prior to your session, you will be asked to fill out some questionnaires and have a few non-invasive assessments. The heating plus psychotherapy session will last 2 hours and 20 minutes. You will be asked to stay an hour following the heating session for observation and to fill out some questionnaires.
Assessments that will take place include:
- A urine toxicology and pregnancy test (if applicable)
- Questionnaires
- Heart rate variability and skin conductivity testing (non-invasive)
During the heating session:
- 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.
- About half way through the session, your regular psychotherapist will come into the room and you will have a one hour psychotherapy session with him/her.
- Following the session you will again fill out some questionnaires