Post Traumatic Stress Disorder (PTSD)PTSD + WBHNCT02077972
Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)
A study testing High intensity whole-body infrared heating in people with Post Traumatic Stress Disorder (PTSD), run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- High intensity whole-body infrared heating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2016
- 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.
- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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),
- individuals with hypersensitivity to heat,
- individuals with recent acute joint injury (i.e. arthritis),
- 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.
- Presence of clinically significant suicide risk, based on the investigator's opinion, or a Columbia Suicide Severity Risk Scale (C-SSRS) suicidal ideation score of 4 or 5. Any suicide attempt within 3 months of the Screening visit is exclusionary.
- Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of a stable dosage of benzodiazepine or non-benzodiazepine hypnotic medications (e.g. zolpidem (Ambien), zaleplon (Sonata), eszopiclone (Lunesta), lorazepam (Ativan), diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax),
- Need for any non-protocol psychotropic medication once enrolled, with the exception of benzodiazepine or non-benzodiazepine hypnotics used at a stable dosage.
- Use of any psychoactive dietary or herbal products in the 2 weeks prior to screening visit 2, or at any time during the trial.
- 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 at the PI's discretion to 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, except for fully resected non-melanoma skin cancer.
- Diabetes mellitus types I or II.
- Any clinically significant autoimmune disease (compensated hypothyroidism allowed).
- Active alcohol/drug abuse in 2 weeks prior to screening for those who have been dependent or have abused on drugs/alcohol in the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Being tested
- High intensity whole-body infrared heating
- Keywords
- PTSD, Military service, depression, Whole Body Hyperthermia (WBH)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High intensity whole-body infrared heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 and 4 weeks post Intervention
Secondary outcomes (4)
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Percent change in scores between baseline and subsequent assessments will be assessed.
Measured: Baseline, 1 and 4 weeks following WBH intervention
Change in Scores on the Brief COPE Measure
Percent change in scores between baseline and subsequent assessments will be assessed.
Measured: Baseline, 1 and 4 weeks following WBH Intervention
Change in scores on the Post Traumatic Stress Disorder Checklist (Military)
Percent change in scores between baseline and subsequent assessments will be assessed using the PCL-Military checklist.
Measured: Baseline, 1 and 4 weeks following the WBH intervention
Change in scores on the Primary Care PTSD Screen
Percent change in scores between baseline and subsequent assessments will be assessed using the Primary Care PTSD Screen.
Measured: Baseline, 1 and 4 weeks following the WBH intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (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 Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles (Chuck) Raison, University of Arizona
- Investigators
- Charles Raison, MD, Principal investigator, University of Arizona, Department of Psychiatry, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077972
- Sponsor's protocol ID
- 13-1216-7558
- Acronym
- PTSD + WBH
- Status last verified
- Aug 2015
- First submitted
- 28 Feb 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02077972
- Acronym / sponsor ID
- PTSD + WBH / 13-1216-7558
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Military service, depression, Whole Body Hyperthermia (WBH)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator transferred to the University of Wisconsin - Madison
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 4 Mar 2014 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High intensity whole-body infrared heating | Experimental | Device: High intensity whole-body infrared heatingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
- 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.
Key exclusion criteria (34 listed)
- 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
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 |
Primary outcome
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.
4 secondary outcomes
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Time frame: Baseline, 1 and 4 weeks following WBH intervention
Change in Scores on the Brief COPE Measure
Time frame: Baseline, 1 and 4 weeks following WBH Intervention
Change in scores on the Post Traumatic Stress Disorder Checklist (Military)
Time frame: Baseline, 1 and 4 weeks following the WBH intervention
Change in scores on the Primary Care PTSD Screen
Time frame: Baseline, 1 and 4 weeks following the WBH 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 10 Aug 2015.
Related trials for Post Traumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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
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 in people with Post Traumatic Stress Disorder (PTSD), run by University of Arizona 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 6 inclusion and 34 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 10 Aug 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. 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?
Clinician Assessment of PTSD Scale (CAPS) (time frame: Baseline, 1 and 4 weeks post Intervention). 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 10 Aug 2015.