Major Depressive DisorderNCT02021149
Enhancing Psychotherapy for Mood Disorders With Whole Body Hyperthermia
A study testing High intensity whole-body infrared heating, Psychotherapy and Questionnaires in people with Major Depressive Disorder, run by Charles (Chuck) Raison at 1 site in United States.
Trial summary
According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9 million American adults, or 9.5 percent of the population over the age of 18 suffer from mood disorders including major depressive disorder, chronic, mild depression and bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- High intensity whole-body infrared heating, Psychotherapy and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 18-65.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English with study personnel.
- For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.
Who cannot join
- Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
- A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
- Subject has a medical condition or disorder that:
- Is unstable and clinically significant, or:
- Could interfere with the accurate assessment of safety or efficacy of treatment, including:
Show all 27Show fewer
- individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,
- individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
- individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
- hemophiliacs/individuals prone to bleeding,
- individuals with a fever the day of study intervention,
- individuals with hypersensitivity to heat,
- individuals with recent acute joint injury,
- individuals with enclosed infections, be they dental, in joints, or in any other tissues,
- Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam as presented to the research team.
- Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of hypnotic medications (zolpidem, zaleplon, eszopiclone).
- Need for any non-protocol psychotropic medication during the trial, with the exception of hypnotics used up to four nights per week.
- Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
- Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial for depression, as well as drug trials with agents that might affect mood or regulation of body temperature.
- Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
- Obesity and overall size of subject. It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
- History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
- History of a cerebral vascular accident
- History of stroke, epilepsy or cerebral aneurisms
- Cancer in the last five years.
- Diabetes mellitus types I or II
- Any clinically significant autoimmune disease (compensated hypothyroidism allowed)
Trial locations and contacts
1 site in 1 country.
About this study
According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9 million American adults, or 9.5 percent of the population over the age of 18 suffer from mood disorders including major depressive disorder, chronic, mild depression and bipolar disorder. Major depressive disorder (MDD) is predicted to be the second leading cause of disability worldwide by the year 2020; sub-clinical mood disturbances impact many additional people and are a major reason people seek psychotherapy services. The economic burden of depression in the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients will fail to adequately respond to all currently available interventions. Moreover, current treatments come at the cost of significant central nervous system (CNS) side effects, further highlighting the need for more effective treatments with fewer side effects. To address these pressing clinical issues, the investigators will conduct a placebo controlled, clinical trial to determine if Whole Body Hyperthermia (WBH) enhances the effects of psychotherapy compared to psychotherapy alone in medically healthy patients with moderate to severe mood disorders. The investigators plan to recruit a sample of 24 medically healthy individuals with mood problems who will be randomized to examine whether WBH enhances the effects of psychotherapy. To determine acute and sustained effects of WBH +psychotherapy on mood disorders, the study will include basic psychiatric questionnaire-based assessments at three therapy sessions prior to a single session conducted while receiving one of two intensities of WBH treatment. Subjects who elect not to conduct a therapy session in the WBH chamber will still be able to complete study questionnaires at all therapy sessions. This study challenges the existing paradigm by determining if peripheral afferent sensory pathways can be accessed to enhance the treatment of mood disorders and thus avoid problems of exposing all of the brain to non-selective drugs.
Read the detailed description
Our research group has observed in an open trial that a single session of whole body hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week in patients with major depression (MDD) severe enough to warrant inpatient hospitalization. In addition to reducing depression, the single session of WBH induced a prolonged reduction in mean core body temperature, consistent with basic science data from our group suggesting that hyperthermia activates a skin-to-brain pathway that targets specific serotonergic nuclei in the raphe. In animal models, these nuclei have been shown to be important for mood and body temperature regulation. Consistent with this known anatomy in our preliminary study in depressed patients, reductions in core body temperature were highly correlated with reductions in depressive symptoms over the same time period (one week post WBH). Moreover, patients with higher mean core body temperature prior to treatment had enhanced antidepressant effects. Because increased body temperature is an outcome of poor functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may actually sensitize this pathway in ways that promote changes in brain functioning known to promote emotional well-being. The results of our first open trial have encouraged us to conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which is currently underway at the University of Arizona Medical School.
In addition to impacting depressive symptoms and body temperature, The investigators have observed that WBH induces striking increases in prosocial and self-disclosing behavior in many individuals. This effect initiates in the heating phase of the treatment and culminates at maximum body temperature. Importantly, our observations thus far suggest that this prosociality only occurs when the person in the hyperthermia box is accompanied by someone he/she knows to at least some degree. For example, a recent subject was silent during his initial WBH treatment in which he was attended by one of our staff that he had never met. He elected to get a repeat WBH session. The same "attendant" was present for this second WBH session, and during this session the patient became strikingly talkative and without prompting self-disclosed a range of very intimate personal issues related to his depression, such as a previously undisclosed history of childhood sexual abuse.
The goal of the current proposal is to conduct a pilot study to evaluate whether this observed prosocial effect of WBH might be employed to accelerate and deepen the formation of therapeutic alliance in patients undergoing an 8-12 session course of cognitive behavioral psychotherapy (CBT). Our study design will also more rigorously test our clinical observation about the prosocial effects of WBH. In addition to potentially enhancing psychotherapeutic outcomes, the current study may provide data relevant to larger issues related to the near universal use of hyperthermia in indigenous cultures around the world for spiritual and health purposes.
- Conditions
- Major Depressive Disorder
- Being tested
- High intensity whole-body infrared heating, Psychotherapy, Questionnaires, Low intensity whole-body infrared heating
- Keywords
- Major Depressive Disorder, Whole Body Hyperthermia, Psychotherapy, Therapist and patient alliance
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity whole-body infrared heatingDevice
The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
PsychotherapyBehavioural
Weekly psychotherapy using cognitive behavioral therapy sessions with a therapist.
QuestionnairesOther
Weekly questionnaires to assess changes in mood, perceptions of self and perceptions of effectiveness of the therapist/patient bond will be administered.
Low intensity whole-body infrared heatingDevice
Attenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy and Questionnaire Group | Other | Participants in this arm will have their regular psychotherapy sessions with their psychotherapist and will, prior to each session, fill out study related questionnaires. Receives: Behavioral: Psychotherapy; Other: Questionnaires |
| High intensity whole-body infrared heating and Psychotherapy. | Experimental | Subjects will have weekly psychotherapy sessions and fill out study questionnaires. The participant's 4th psychotherapy session will be conducted while the patient undergoes the WBH intervention where subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C.temperature. Receives: Device: High intensity whole-body infrared heating; Behavioral: Psychotherapy; Other: Questionnaires |
| Low intensity whole-body infrared heating and Psychotherapy | Sham comparator | Subjects will have weekly psychotherapy sessions and fill out study questionnaires. The participant's 4th psychotherapy session will be conducted while the patient undergoes WBH-control where subjects will be induced to levels of heat that causes only a minor increase in body temperature. Receives: Behavioral: Psychotherapy; Other: Questionnaires; Device: Low intensity whole-body infrared heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Percentage change in scores between baseline and subsequent assessments will be assessed.
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in Therapeutic bond / alliance
Percentage change over time in the therapeutic alliance between patients and their therapists.
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12).
Secondary outcomes (4)
Change in depression scores over time (OQ-45 Measurement)
Percent change in scores between baseline and subsequent assessments will be assessed.
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in Vitality
Percent change in scores between baseline and subsequent assessments will be assessed using a vitality scale.
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in Positive and Negative Affect
Percent change in positive and negative affect will be assessed between baseline and subsequent assessments using the Positive and Negative Affect Schedule (PANAS)
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in relationship with psychotherapist
The investigators will use qualitative coding of psychotherapy sessions recorded at each psychotherapy session to assess whether WBH + psychotherapy affects and strengthens the ways in which patients relate to their psychotherapist and determined whether or not it enhances psychotherapy treatment.
Measured: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJul 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Investigator transferred to the University of Wisconsin - Madison
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles (Chuck) Raison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charles (Chuck) Raison, University of Arizona
- Investigators
- Charles Raison, MD, Principal investigator, University of Arizona, Department of Psychiatry, College of MedicineDavid Sbarra, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021149
- Sponsor's protocol ID
- 13-0614
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2013
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Psychotherapy for Mood Disorders With Whole Body Hyperthermia
- ClinicalTrials.gov ID
- NCT02021149
- Acronym / sponsor ID
- 13-0614
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Whole Body Hyperthermia, Psychotherapy, Therapist and patient alliance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator transferred to the University of Wisconsin - Madison
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Charles (Chuck) RaisonUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9 million American adults, or 9.5 percent of the population over the age of 18 suffer from mood disorders including major depressive disorder, chronic, mild depression and bipolar disorder. Major depressive disorder (MDD) is predicted to be the second leading cause of disability worldwide by the year 2020; sub-clinical mood disturbances impact many additional people and are a major reason people seek psychotherapy services. The economic burden of depression in the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients will fail to adequately respond to all currently available interventions. Moreover, current treatments come at the cost of significant central nervous system (CNS) side effects, further highlighting the need for more effective treatments with fewer side effects. To address these pressing clinical issues, the investigators will conduct a placebo controlled, clinical trial to determine if Whole Body Hyperthermia (WBH) enhances the effects of psychotherapy compared to psychotherapy alone in medically healthy patients with moderate to severe mood disorders. The investigators plan to recruit a sample of 24 medically healthy individuals with mood problems who will be randomized to examine whether WBH enhances the effects of psychotherapy. To determine acute and sustained effects of WBH +psychotherapy on mood disorders, the study will include basic psychiatric questionnaire-based assessments at three therapy sessions prior to a single session conducted while receiving one of two intensities of WBH treatment. Subjects who elect not to conduct a therapy session in the WBH chamber will still be able to complete study questionnaires at all therapy sessions. This study challenges the existing paradigm by determining if peripheral afferent sensory pathways can be accessed to enhance the treatment of mood disorders and thus avoid problems of exposing all of the brain to non-selective drugs.
Detailed description
Our research group has observed in an open trial that a single session of whole body hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week in patients with major depression (MDD) severe enough to warrant inpatient hospitalization. In addition to reducing depression, the single session of WBH induced a prolonged reduction in mean core body temperature, consistent with basic science data from our group suggesting that hyperthermia activates a skin-to-brain pathway that targets specific serotonergic nuclei in the raphe. In animal models, these nuclei have been shown to be important for mood and body temperature regulation. Consistent with this known anatomy in our preliminary study in depressed patients, reductions in core body temperature were highly correlated with reductions in depressive symptoms over the same time period (one week post WBH). Moreover, patients with higher mean core body temperature prior to treatment had enhanced antidepressant effects. Because increased body temperature is an outcome of poor functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may actually sensitize this pathway in ways that promote changes in brain functioning known to promote emotional well-being. The results of our first open trial have encouraged us to conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which is currently underway at the University of Arizona Medical School.
In addition to impacting depressive symptoms and body temperature, The investigators have observed that WBH induces striking increases in prosocial and self-disclosing behavior in many individuals. This effect initiates in the heating phase of the treatment and culminates at maximum body temperature. Importantly, our observations thus far suggest that this prosociality only occurs when the person in the hyperthermia box is accompanied by someone he/she knows to at least some degree. For example, a recent subject was silent during his initial WBH treatment in which he was attended by one of our staff that he had never met. He elected to get a repeat WBH session. The same "attendant" was present for this second WBH session, and during this session the patient became strikingly talkative and without prompting self-disclosed a range of very intimate personal issues related to his depression, such as a previously undisclosed history of childhood sexual abuse.
The goal of the current proposal is to conduct a pilot study to evaluate whether this observed prosocial effect of WBH might be employed to accelerate and deepen the formation of therapeutic alliance in patients undergoing an 8-12 session course of cognitive behavioral psychotherapy (CBT). Our study design will also more rigorously test our clinical observation about the prosocial effects of WBH. In addition to potentially enhancing psychotherapeutic outcomes, the current study may provide data relevant to larger issues related to the near universal use of hyperthermia in indigenous cultures around the world for spiritual and health purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy and Questionnaire Group | Other | Behavioral: Psychotherapy, Other: QuestionnairesParticipants in this arm will have their regular psychotherapy sessions with their psychotherapist and will, prior to each session, fill out study related questionnaires. |
| High intensity whole-body infrared heating and Psychotherapy. | Experimental | Device: High intensity whole-body infrared heating, Behavioral: Psychotherapy, Other: QuestionnairesSubjects will have weekly psychotherapy sessions and fill out study questionnaires. The participant's 4th psychotherapy session will be conducted while the patient undergoes the WBH intervention where subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C.temperature. |
| Low intensity whole-body infrared heating and Psychotherapy | Sham comparator | Behavioral: Psychotherapy, Other: Questionnaires, Device: Low intensity whole-body infrared heatingSubjects will have weekly psychotherapy sessions and fill out study questionnaires. The participant's 4th psychotherapy session will be conducted while the patient undergoes WBH-control where subjects will be induced to levels of heat that causes only a minor increase in body temperature. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients aged 18-65.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English with study personnel.
- For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.
Key exclusion criteria (27 listed)
- Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
- A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
- Subject has a medical condition or disorder that:
- Is unstable and clinically significant, or:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity whole-body infrared heatingThe Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C. | Device | High intensity whole-body infrared heating and Psychotherapy. |
| PsychotherapyWeekly psychotherapy using cognitive behavioral therapy sessions with a therapist. | Behavioural | High intensity whole-body infrared heating and Psychotherapy., Low intensity whole-body infrared heating and Psychotherapy, Psychotherapy and Questionnaire Group |
| QuestionnairesWeekly questionnaires to assess changes in mood, perceptions of self and perceptions of effectiveness of the therapist/patient bond will be administered. | Other | High intensity whole-body infrared heating and Psychotherapy., Low intensity whole-body infrared heating and Psychotherapy, Psychotherapy and Questionnaire Group |
| Low intensity whole-body infrared heatingAttenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time. | Device | Low intensity whole-body infrared heating and Psychotherapy |
Primary outcome
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Percentage change in scores between baseline and subsequent assessments will be assessed.
Change in Therapeutic bond / alliance
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12).
Percentage change over time in the therapeutic alliance between patients and their therapists.
4 secondary outcomes
Change in depression scores over time (OQ-45 Measurement)
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in Vitality
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in Positive and Negative Affect
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Change in relationship with psychotherapist
Time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.
Results and safety
The study was stopped early (reason given: Investigator transferred to the University of Wisconsin - Madison). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Raison, MD principal investigator
University of Arizona, Department of Psychiatry, College of Medicine
David Sbarra, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity whole-body infrared heating, Psychotherapy and Questionnaires in people with Major Depressive Disorder, run by Charles (Chuck) Raison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator transferred to the University of Wisconsin - Madison). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)] (time frame: Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.