Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)

NCT02077972 | Terminated

• 1 other identifier: 13-1216-7558
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing public health problem in the United States following the overseas wars of the last decade. Rates of PTSD have skyrocketed in the military and among veterans, leading to increased rates of suicide, impairment on the job and off, and behavioral changes that negatively affect not just the veteran, but also his or her family. Although effective medication and psychotherapy treatments exist for combat-related PTSD, many individuals suffering with PTSD do not adequately respond to currently available treatment options, highlighting the need to develop and test new interventions for the disorder. To address this pressing clinical issue, the investigators will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms in adults suffering from combat-related PTSD. The investigators plan to recruit a sample of 10 medically healthy individuals with combat-related PTSD who will receive a single session of WBH to determine if this single session improves PTSD symptoms and, if so, whether this improvement will last at least 2 weeks. To do this, the study will include basic clinical and psychiatric assessments immediately before and one and four weeks after WBH. Because sleep is so often impaired in PTSD, the investigators will measure at-home sleep patterns for a week prior to and a week following the WBH session using sleep diaries and a wristwatch actigraphy device. Given scientific evidence from our research group that WBH may improve depression, the investigators anticipate that it may also be of benefit or adults suffering from combat-related PTSD.

Conditions

Post Traumatic Stress Disorder (PTSD)

Keywords

PTSD; Military service; depression; Whole Body Hyperthermia (WBH)

Outcome Measures

Primary Outcomes (1)

• Clinician Assessment of PTSD Scale (CAPS)

  Change in scores between baseline and subsequent assessments will be assessed to determine the effect of WBH on PTSD symptoms.

  Baseline, 1 and 4 weeks post Intervention

Secondary Outcomes (4)

• Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]

  Baseline, 1 and 4 weeks following WBH intervention

• Change in Scores on the Brief COPE Measure

  Baseline, 1 and 4 weeks following WBH Intervention

• Change in scores on the Post Traumatic Stress Disorder Checklist (Military)

  Baseline, 1 and 4 weeks following the WBH intervention

• Change in scores on the Primary Care PTSD Screen

  Baseline, 1 and 4 weeks following the WBH intervention

Study Arms (1)

High intensity whole-body infrared heating

EXPERIMENTAL

The participant will undergo 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

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

Eligibility Criteria

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

You may 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.
• A diagnosis of combat-related PTSD based on a PTSD Checklist (PCL)-Military Version score of 50 or greater and meets a diagnosis of PTSD by DSM-V criteria.
• In the investigator's opinion, has met DSM-V criteria for PTSD for at least 4 weeks prior to signing consent.
• Able to communicate in English with study personnel.
• 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 per self-report.

You may not qualify if:

• Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
• A current DSM-IV-TR Axis I diagnosis of Dementia; or
• Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
• A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
• 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 met DSM-IV criteria for Substance Abuse in the month prior to screening visit, or non-remitted Substance Dependence in the 2 weeks prior to screening visit.
• A diagnosis of an anxiety or mood disorder that is considered by the investigator to be of greater source of distress or functional impairment than the patient's PTSD diagnosis. Subjects with co-morbid anxiety and mood disorders not excluded above and considered to be of secondary importance will be permitted in the study.
• Participation in concurrent formal psychotherapy during the trial, or in the 2 weeks prior to the screening visit.
• 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 (if so, they will be rescheduled),

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85741, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Charles Raison, MD

  University of Arizona, Department of Psychiatry, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Professor of Psychiatry

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

US (1)