Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD) (PTSD + WBH)
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|ClinicalTrials.gov Identifier: NCT02077972|
Recruitment Status : Terminated (Investigator transferred to the University of Wisconsin - Madison)
First Posted : March 4, 2014
Last Update Posted : August 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder (PTSD)||Device: High intensity whole-body infrared heating||Not Applicable|
The investigators will direct a clinical trial of Whole Body Hyperthermia (WBH) for treatment of PTSD related to combat exposure. Although the investigators have not yet studied WBH for PTSD, the investigators have data indicating that WBH is effective for the acute treatment of major depression (MDD). Given the high overlap of symptoms between PTSD and Major Depressive Disorder (MDD), as well as the fact that most people with PTSD also meet criteria for MDD, the investigators have reasons for expecting that WBH may also be of benefit for PTSD. The primary objective of the proposed study is to determine if WBH produces improvement in core PTSD symptoms, just as it appears to do in MDD. Indeed, in preliminary studies, a single exposure to WBH resulted in a downward shift in body temperature and a decrease in depressive symptoms as measured using the Center for Epidemiologic Studies Depression Scale (known as the ADS in Germany where this study was conducted) 5 days later. In addition, following exclusion of one patient with bronchopulmonary inflammation that did not show a decrease in body temperature following treatment, a correlation between the shift in body temperature and ΔADS approached statistical significance. These preliminary data are consistent with previous studies showing that 1) patients with seasonal affective disorder in winter during depression have blunted thermoregulatory cooling but have thermoregulatory cooling that is similar in efficiency to control subjects after successful antidepressant response to phototherapy (the retina has direct projections to DRVL serotonergic neurons), 2) ECT increases the circadian amplitude of core body temperature, and decreases mean core body temperature, particularly during the nighttime thermoregulatory cooling period, and 3) thermoregulatory cooling, as evidenced by the number of active sweat glands in depressed patients, increases upon clinical recovery, but not earlier, following ECT. the investigators hypothesize that these relationships in preliminary data and in previous studies are due to dysfunction of the afferent signaling arm of the thermoregulatory system in MDD, specifically the warm afferent system projecting to the LPB and, secondarily, to the DRVL/VLPAG and DRI subsets of serotonergic neurons that have been implicated in anxiolytic and antidepressant actions, respectively, and to normalization of warm afferent signaling following treatment. Again, given the high degree of overlap between PTSD and MDD, the investigators expect that WBH may confer therapeutic benefits in PTSD as it appears to do in MDD.
This clinical trial will only include individuals with PTSD (i.e. no normal controls) in order to determine whether there is a significant effect of a single treatment with WBH administered in an open manner on PTSD symptoms. Based on our data from patients with MDD, the investigators expect that if WBH has an effect on PTSD symptoms, this will be apparent immediately after the treatment and will persist for at least a week. Therefore, the investigators will assess PTSD symptoms prior to and a week following a single treatment with WBH.
Useful preliminary results were obtained from a pilot study comparing mildly to severely depressed patients receiving hyperthermic treatment (N=11) to depressed patients receiving psychotherapy as usual (N=3). Baseline scores on the German language ADS depression scale were similar for the two groups (mean=30.64, sd=9.18, N=11, vs. mean =32.33, sd=17.04, N=3). Raw change on the ADS was significantly greater for the hyperthermia group (mean=-11.91, sd=6.55, N=11, vs. mean=-1.33, sd=4.51, N=3; t=2.60, df=12, P=0.023), resulting in a very large standardized treatment difference (Cohen d) of 1.69 (95% CI=1.00 - 2.48). Percent change was also significant (mean=-39.4, sd=18.9, N=11, vs. mean=-8.6, sd=17.0, N=3; t=2.54; df=12, P=0.026), for a Cohen d of 1.66 (95% CI=0.93 - 2.39). The percentage of the hyperthermia vs. psychotherapy group achieving a clinical response (>50% reduction from baseline) was 27.3% vs. 0%, and the percentage achieving at least a partial response (>25% improvement) was 81.8% vs. 33.3%. These data suggest that our proposed sample size of 10 individuals with combat-related PTSD should be sufficient to identify a potential therapeutic effect, assuming that such an effect would be of similar magnitude to the effect seen in MDD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
Experimental: High intensity whole-body infrared heating
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
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.
- Clinician Assessment of PTSD Scale (CAPS) [ Time Frame: Baseline, 1 and 4 weeks post Intervention ]Change in scores between baseline and subsequent assessments will be assessed to determine the effect of WBH on PTSD symptoms.
- Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)] [ Time Frame: Baseline, 1 and 4 weeks following WBH intervention ]Percent change in scores between baseline and subsequent assessments will be assessed.
- Change in Scores on the Brief COPE Measure [ Time Frame: Baseline, 1 and 4 weeks following WBH Intervention ]Percent change in scores between baseline and subsequent assessments will be assessed.
- Change in scores on the Post Traumatic Stress Disorder Checklist (Military) [ Time Frame: Baseline, 1 and 4 weeks following the WBH intervention ]Percent change in scores between baseline and subsequent assessments will be assessed using the PCL-Military checklist.
- Change in scores on the Primary Care PTSD Screen [ Time Frame: Baseline, 1 and 4 weeks following the WBH intervention ]Percent change in scores between baseline and subsequent assessments will be assessed using the Primary Care PTSD Screen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077972
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85741|
|Principal Investigator:||Charles Raison, MD||University of Arizona, Department of Psychiatry, College of Medicine|