Enhancing Psychotherapy for Mood Disorders With Whole Body Hyperthermia

NCT02021149 | Terminated

• 1 other identifier: 13-0614
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Whole Body Hyperthermia; Psychotherapy; Therapist and patient alliance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intake Session and at therapy sessions every week thereafter (Weeks 2-12).

Secondary Outcomes (4)

• Change in depression scores over time (OQ-45 Measurement)

  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

  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

  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

  Intake Session and at therapy sessions every week thereafter (Weeks 2-12), including the session that occurs during the WBH/WBH-control intervention.

Study Arms (3)

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.

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.

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.

Behavioral: Psychotherapy; Other: Questionnaires; Device: Low intensity whole-body infrared heating

Interventions

High intensity whole-body infrared heating DEVICE

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.

High intensity whole-body infrared heating and Psychotherapy.

Psychotherapy BEHAVIORAL

Weekly psychotherapy using cognitive behavioral therapy sessions with a therapist.

High intensity whole-body infrared heating and Psychotherapy.; Low intensity whole-body infrared heating and Psychotherapy; Psychotherapy and Questionnaire Group

Questionnaires OTHER

Weekly questionnaires to assess changes in mood, perceptions of self and perceptions of effectiveness of the therapist/patient bond will be administered.

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 heating DEVICE

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.

Low intensity whole-body infrared heating and Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Charles (Chuck) Raison: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85741, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Psychotherapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charles Raison, MD

  University of Arizona, Department of Psychiatry, College of Medicine

  PRINCIPAL INVESTIGATOR

• David Sbarra, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry (College of Medicine) and the Norton School of Family and Consumer Sciences

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 27, 2013
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (1)