Enhancing Psychotherapy for Mood Disorders With Whole Body Hyperthermia
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | November 2015 |
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.
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.
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.
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.
Inclusion Criteria for Psychotherapy and Questionnaire Group:
- The only inclusion criteria for this group is that they are deemed eligible to receive
psychotherapy at the Psychology Department Clinic, are fluent in English and are
interested in participating in the study. There are no specific exclusion criteria for
this study group.
Inclusion Criteria for WBH Psychotherapy Group:
- 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.
Exclusion Criteria:
- 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:
- 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)
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