Stress Disorders, Post-TraumaticNCT05309031
An Immersion Intervention for Symptoms of PTSD in Student Veterans
A study testing Water Immersion in people with Stress Disorders, Post-Traumatic, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
This study will explore the physical and psychological effects of warm water immersion to the chest on student Veterans who experience symptoms of Post-Traumatic Stress Disorder (PTSD) and may also have depression, anxiety and pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Water Immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Self-report of previous military service, current enrollment as a student at UNLV, and current PTSD symptoms. They must be able to enter and exit the pool without assistance.
Who cannot join
- Self-report of current dental, cardiac, pulmonary or kidney disease, uncontrolled diabetes, HIV, hepatitis, mental illness (except depression), traumatic brain injury, morbid obesity, open wounds, fear of water, or missing lower extremities and presumptive or confirmed pregnancy. Pharmacologics, including antidepressants, analgesics and non-steroidal anti-inflammatories, will not be controlled for because of the difficulty of recruiting participants without comorbid depression or pain.
Trial locations and contacts
1 site in 1 country.
About this study
This study will explore the physical and psychological effects of warm water immersion to the chest on student Veterans who experience symptoms of Post-Traumatic Stress Disorder (PTSD) and may also have depression, anxiety and pain.
Read the detailed description
Procedure/Protocol
Data collection will occur over 15+ consecutive weeks depending on recruitment success and scheduling availability of participants.
Day 1: After reviewing, answering questions and signing the consent form with the PI (5-20 min) , demographic information will be collected, the PCL-5 (10 min), PHQ-9 (10 min) and CES scale (5 min) will be administered by a clinical psychologist or psychiatric nurse practitioner in a private room at the SON Research Office using paper instruments.
Day 2: Data will be collected on one participant at each session at the same time of the day to control for circadian rhythms in salivary sAA, using Salimetrics protocols: 1. Collection Methods: SalivaBio Oral Swab and 2. Collecting Salivary Amylase (Appendix 11 Swab, Appendix 12 Collection). Data will be collected at the Centennial Hills YMCA and includes these activities:
Salivary Amylase
- Avoid foods with high sugar or acidity, immediately before sample collection, since they may compromise the assay by lowering saliva pH and increasing bacterial growth.
- Document consumption of alcohol, caffeine, nicotine, and prescription/over-the-counter medications within the prior 12 hours.
- Medications that specifically agonize or antagonize alpha- or beta-adrenergic processes should be avoided
- Document vigorous physical activity and the presence of oral diseases or injury.
- Consider documenting parameters to estimate saliva flow rate.
- Rinse mouth with water to remove food residue and wait at least 10 minutes after rinsing to avoid sample dilution before collecting saliva.
Protocol After arrival at the YMCA, participants will remain seated for 10 min in a quiet room adjacent to the pool area. Then pencil and paper instruments (VASA [20 sec], VASP [20 sec], MDMQ [ 7min]) will be administered and sAA collected (5min) by the PI . Next, participants will change into swimwear and enter the pool (Appendix 13 Pool Photo). A timer will be set for 15 and 45 min of immersion, with the same sequence of data collected while participants are in the water. A lifeguard will be in attendance. Following completion of the immersion intervention, participants will get dressed in the adjacent locker room and be escorted to a private room adjacent to the pool area where individual interviews will be conducted (30-60 min).
All participants are able to withdraw from the study at any time. If data has been collected on day 1 and on day 2 at baseline and 15 minutes it will be retained and analyzed.
An interview guide consisting of questions related to the intervention and participant cues will direct the conversation (Appendix 10 Interview Questions).
The interview will be initiated using a grand tour question, such as "Tell me about your experience while immersed in the water. How did you feel?" then proceed to more directed questions related to specific symptoms and specific emotional and psychological responses to the intervention (immersion). Participants may be asked to expand on specific items as applicable. At the conclusion, the participant will be asked if they have any questions or if there is anything else they would like to add. All interviews will be audio-recorded and transcribed, however, if any participants do not consent to be recorded, the researcher will take notes. Participants may conclude the interview at any time, and should they experience distress or strong emotions, the interview will be terminated. All participants will be provided with a list of available support resources.
Semi-structured interview and audio recording of the interview will be conducted in a private conference room. Only participant code numbers will be included. The audio recording on the digital recorder will never leave the investigator's presence and will be saved to the investigator's desktop on a private, pass coded protected UNLV computer, housed in a locked room. The audio recording will be immediately saved to the secure UNLV google shared drive and immediately deleted from the digital recorder and the computer desktop.
Before beginning the interview, participants will be informed that the meeting is being recorded prior to beginning the conversation. They will also be informed that the audio recording of the interview is being saved for analysis. Participants will be informed that a "code number" will be used during the interview to protect their identity.
A certified transcriptionist service Rev.com will transcribe the digitally audio recorded interview data verbatim. Rev.com has an established transcriber confidentiality agreement signed by all transcriptionists. The digitally audio recorded interview will be labeled with unique anonymous code number identifier and securely digitally delivered to the transcribing service. Transcribed transcripts will not contain personal identifying information about the participant. Once the audio recording has been converted to text, the recording residing on the secure UNLV google shared drive will be destroyed.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Water Immersion
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water ImmersionOther
Participants will enter the pool, which has a thermoneutral temperature of 33°C (92°F), warm enough to be comfortable, but cool enough to avoid an increase in HR with similar ambient air temperature. A maximum depth of 4 to 4 feet 6 inches allows ample room participants to be immersed to the chest, float vertically and move in the pool. During 45 min of immersion, they will be instructed to stand, walk and move ad lib. Noodles will be available to hang or rest on in a vertical position. Taller participants will remain at the pool's deep end. The timeframe was chosen to approximate our previous immersion intervention length.
| Study group | Role | What they receive |
|---|---|---|
| Immersion | Experimental | This group will receive the immersion intervention Receives: Other: Water Immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Alpha-Amylase change is being assessed
Salivary alpha-amylase samples will be analyzed by Salametrics, Carlsbad, CA using a Saliva Bio Oral Swab device and Swab Storage Tube, immediately placed on ice and frozen within 2 hours at -70 degrees. Frozen sample aliquots containing at least 325µL, will be shipped at one time, on dry ice for analysis using .25 µL, by a Kinetic Reaction assay, with a sensitivity of 0.4 U/ml, range of 2 - 400 U/ml. Samples are run in duplicate.
Measured: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Multidimensional Mood State Questionnaire (MDMQ) Change is being assessed
The Multidimensional Mood State Questionnaire (MDMQ) is an English version of the German Multidimensional Mood State Questionnaire. It is based on the condition diagnosis of three mood dimensions "elevated-depressed" (German) "good-bad" (English), (G Scale) "wakefulness drowsiness" (German) "awake-tired" (W Scale) and "restlessness" (German) "calm-nervous" (R scale) and considers situational effects. The reliabilities at four measurement times using split-half correlation with subsequent Spearman-Brown test extension calculation of the German version are G scale between .96 and .97, W scale between .94 and .96 and R scale between .87 and .94 (Steyer et al., 1994). Dr. Rolf Steyer confirms the scale has not been tested in English (personal communication). This scale is simple, easy to use and measures current mood.
Measured: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Visual Analogue Scale (VAS) for Anxiety Change is being assessed
Visual Analogue Scale (VAS) will measure anxiety. VAS reliability, validity, administration and scoring for anxiety and pain have been previously described (Benfield et al., 2001).Scores range between 0 and 100 mm. Lower scores mean less anxiety.
Measured: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Visual Analogue Scale (VAS) for Pain Change is being assessed
Visual Analogue Scale (VAS) will measure pain. VAS reliability, validity, administration and scoring for anxiety and pain have been previously described (Benfield et al., 2001)Scores range between 0 and 100 mm. Lower scores mean less pain.
Measured: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Semi-structured interview
Individual semi-structured interviews will be completed to explore participant's overall perceptions of the immersion intervention and its effect on their general well-being and symptoms. Interviews will be conducted in a conversational tone, using open-ended questions, and active listening techniques. An interview guide consisting of questions related to the intervention and participant cues will direct the conversation The interview will be initiated using a grand tour question, such as "Tell me about your experience while immersed in the water. How did you feel?" then proceed to more directed questions related to specific symptoms related to specific emotional and psychological responses to the intervention (immersion). All interviews will be audio-recorded and transcribed, however, if any participants do not consent to be recorded, the researcher will take notes. Interviews are expected to take approximately 30 - 60 minutes.
Measured: Immediately following immersion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- 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
- Model description
- Single group repeated measures
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Benfield, University of Nevada, Las Vegas
- Investigators
- Rebecca Benfield, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309031
- Sponsor's protocol ID
- UNevada
- Status last verified
- May 2024
- First submitted
- 16 Mar 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benfield RD, Hortobagyi T, Tanner CJ, Swanson M, Heitkemper MM, Newton ER. The effects of hydrotherapy on anxiety, pain, neuroendocrine responses, and contraction dynamics during labor. Biol Res Nurs. 2010 Jul;12(1):28-36. doi: 10.1177/1099800410361535. Epub 2010 May 7.
PubMed 20453024Epstein M, Preston S, Weitzman RE. Isoosmotic central blood volume expansion suppresses plasma arginine vasopressin in normal man. J Clin Endocrinol Metab. 1981 Feb;52(2):256-62. doi: 10.1210/jcem-52-2-256.
PubMed 7007402Farhi LE, Linnarsson D. Cardiopulmonary readjustments during graded immersion in water at 35 degrees C. Respir Physiol. 1977 Jun;30(1-2):35-50. doi: 10.1016/0034-5687(77)90020-2.
PubMed 877449Hammerum MS, Bie P, Pump B, Johansen LB, Christensen NJ, Norsk P. Vasopressin, angiotensin II and renal responses during water immersion in hydrated humans. J Physiol. 1998 Aug 15;511 ( Pt 1)(Pt 1):323-30. doi: 10.1111/j.1469-7793.1998.323bi.x.
PubMed 9679185Johansen LB, Jensen TU, Pump B, Norsk P. Contribution of abdomen and legs to central blood volume expansion in humans during immersion. J Appl Physiol (1985). 1997 Sep;83(3):695-9. doi: 10.1152/jappl.1997.83.3.695.
PubMed 9292451Nater UM, La Marca R, Florin L, Moses A, Langhans W, Koller MM, Ehlert U. Stress-induced changes in human salivary alpha-amylase activity -- associations with adrenergic activity. Psychoneuroendocrinology. 2006 Jan;31(1):49-58. doi: 10.1016/j.psyneuen.2005.05.010. Epub 2005 Jul 5.
PubMed 16002223Nater UM, Rohleder N, Schlotz W, Ehlert U, Kirschbaum C. Determinants of the diurnal course of salivary alpha-amylase. Psychoneuroendocrinology. 2007 May;32(4):392-401. doi: 10.1016/j.psyneuen.2007.02.007. Epub 2007 Apr 5.
PubMed 17418498Petrakova L, Doering BK, Vits S, Engler H, Rief W, Schedlowski M, Grigoleit JS. Psychosocial Stress Increases Salivary Alpha-Amylase Activity Independently from Plasma Noradrenaline Levels. PLoS One. 2015 Aug 6;10(8):e0134561. doi: 10.1371/journal.pone.0134561. eCollection 2015.
PubMed 26247781de Kloet CS, Vermetten E, Geuze E, Wiegant VM, Westenberg HG. Elevated plasma arginine vasopressin levels in veterans with posttraumatic stress disorder. J Psychiatr Res. 2008 Feb;42(3):192-8. doi: 10.1016/j.jpsychires.2006.11.009. Epub 2007 Jan 11.
PubMed 17222428
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Immersion Intervention for Symptoms of PTSD in Student Veterans
- ClinicalTrials.gov ID
- NCT05309031
- Acronym / sponsor ID
- UNevada
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- 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.
This study will explore the physical and psychological effects of warm water immersion to the chest on student Veterans who experience symptoms of Post-Traumatic Stress Disorder (PTSD) and may also have depression, anxiety and pain.
Detailed description
Procedure/Protocol
Data collection will occur over 15+ consecutive weeks depending on recruitment success and scheduling availability of participants.
Day 1: After reviewing, answering questions and signing the consent form with the PI (5-20 min) , demographic information will be collected, the PCL-5 (10 min), PHQ-9 (10 min) and CES scale (5 min) will be administered by a clinical psychologist or psychiatric nurse practitioner in a private room at the SON Research Office using paper instruments.
Day 2: Data will be collected on one participant at each session at the same time of the day to control for circadian rhythms in salivary sAA, using Salimetrics protocols: 1. Collection Methods: SalivaBio Oral Swab and 2. Collecting Salivary Amylase (Appendix 11 Swab, Appendix 12 Collection). Data will be collected at the Centennial Hills YMCA and includes these activities:
Salivary Amylase
- Avoid foods with high sugar or acidity, immediately before sample collection, since they may compromise the assay by lowering saliva pH and increasing bacterial growth.
- Document consumption of alcohol, caffeine, nicotine, and prescription/over-the-counter medications within the prior 12 hours.
- Medications that specifically agonize or antagonize alpha- or beta-adrenergic processes should be avoided
- Document vigorous physical activity and the presence of oral diseases or injury.
- Consider documenting parameters to estimate saliva flow rate.
- Rinse mouth with water to remove food residue and wait at least 10 minutes after rinsing to avoid sample dilution before collecting saliva.
Protocol After arrival at the YMCA, participants will remain seated for 10 min in a quiet room adjacent to the pool area. Then pencil and paper instruments (VASA [20 sec], VASP [20 sec], MDMQ [ 7min]) will be administered and sAA collected (5min) by the PI . Next, participants will change into swimwear and enter the pool (Appendix 13 Pool Photo). A timer will be set for 15 and 45 min of immersion, with the same sequence of data collected while participants are in the water. A lifeguard will be in attendance. Following completion of the immersion intervention, participants will get dressed in the adjacent locker room and be escorted to a private room adjacent to the pool area where individual interviews will be conducted (30-60 min).
All participants are able to withdraw from the study at any time. If data has been collected on day 1 and on day 2 at baseline and 15 minutes it will be retained and analyzed.
An interview guide consisting of questions related to the intervention and participant cues will direct the conversation (Appendix 10 Interview Questions).
The interview will be initiated using a grand tour question, such as "Tell me about your experience while immersed in the water. How did you feel?" then proceed to more directed questions related to specific symptoms and specific emotional and psychological responses to the intervention (immersion). Participants may be asked to expand on specific items as applicable. At the conclusion, the participant will be asked if they have any questions or if there is anything else they would like to add. All interviews will be audio-recorded and transcribed, however, if any participants do not consent to be recorded, the researcher will take notes. Participants may conclude the interview at any time, and should they experience distress or strong emotions, the interview will be terminated. All participants will be provided with a list of available support resources.
Semi-structured interview and audio recording of the interview will be conducted in a private conference room. Only participant code numbers will be included. The audio recording on the digital recorder will never leave the investigator's presence and will be saved to the investigator's desktop on a private, pass coded protected UNLV computer, housed in a locked room. The audio recording will be immediately saved to the secure UNLV google shared drive and immediately deleted from the digital recorder and the computer desktop.
Before beginning the interview, participants will be informed that the meeting is being recorded prior to beginning the conversation. They will also be informed that the audio recording of the interview is being saved for analysis. Participants will be informed that a "code number" will be used during the interview to protect their identity.
A certified transcriptionist service Rev.com will transcribe the digitally audio recorded interview data verbatim. Rev.com has an established transcriber confidentiality agreement signed by all transcriptionists. The digitally audio recorded interview will be labeled with unique anonymous code number identifier and securely digitally delivered to the transcribing service. Transcribed transcripts will not contain personal identifying information about the participant. Once the audio recording has been converted to text, the recording residing on the secure UNLV google shared drive will be destroyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group repeated measures
| Arm | Type | Receives |
|---|---|---|
| Immersion | Experimental | Other: Water ImmersionThis group will receive the immersion intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self-report of previous military service, current enrollment as a student at UNLV, and current PTSD symptoms. They must be able to enter and exit the pool without assistance.
Key exclusion criteria (1 listed)
- Self-report of current dental, cardiac, pulmonary or kidney disease, uncontrolled diabetes, HIV, hepatitis, mental illness (except depression), traumatic brain injury, morbid obesity, open wounds, fear of water, or missing lower extremities and presumptive or confirmed pregnancy. Pharmacologics, including antidepressants, analgesics and non-steroidal anti-inflammatories, will not be controlled for because of the difficulty of recruiting participants without comorbid depression or pain.
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 |
|---|---|---|
| Water ImmersionParticipants will enter the pool, which has a thermoneutral temperature of 33°C (92°F), warm enough to be comfortable, but cool enough to avoid an increase in HR with similar ambient air temperature. A maximum depth of 4 to 4 feet 6 inches allows ample room participants to be immersed to the chest, float vertically and move in the pool. During 45 min of immersion, they will be instructed to stand, walk and move ad lib. Noodles will be available to hang or rest on in a vertical position. Taller participants will remain at the pool's deep end. The timeframe was chosen to approximate our previous immersion intervention length. | Other | Immersion |
Primary outcome
Salivary Alpha-Amylase change is being assessed
Time frame: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Salivary alpha-amylase samples will be analyzed by Salametrics, Carlsbad, CA using a Saliva Bio Oral Swab device and Swab Storage Tube, immediately placed on ice and frozen within 2 hours at -70 degrees. Frozen sample aliquots containing at least 325µL, will be shipped at one time, on dry ice for analysis using .25 µL, by a Kinetic Reaction assay, with a sensitivity of 0.4 U/ml, range of 2 - 400 U/ml. Samples are run in duplicate.
Multidimensional Mood State Questionnaire (MDMQ) Change is being assessed
Time frame: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
The Multidimensional Mood State Questionnaire (MDMQ) is an English version of the German Multidimensional Mood State Questionnaire. It is based on the condition diagnosis of three mood dimensions "elevated-depressed" (German) "good-bad" (English), (G Scale) "wakefulness drowsiness" (German) "awake-tired" (W Scale) and "restlessness" (German) "calm-nervous" (R scale) and considers situational effects. The reliabilities at four measurement times using split-half correlation with subsequent Spearman-Brown test extension calculation of the German version are G scale between .96 and .97, W scale between .94 and .96 and R scale between .87 and .94 (Steyer et al., 1994). Dr. Rolf Steyer confirms the scale has not been tested in English (personal communication). This scale is simple, easy to use and measures current mood.
Visual Analogue Scale (VAS) for Anxiety Change is being assessed
Time frame: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Visual Analogue Scale (VAS) will measure anxiety. VAS reliability, validity, administration and scoring for anxiety and pain have been previously described (Benfield et al., 2001).Scores range between 0 and 100 mm. Lower scores mean less anxiety.
Visual Analogue Scale (VAS) for Pain Change is being assessed
Time frame: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)
Visual Analogue Scale (VAS) will measure pain. VAS reliability, validity, administration and scoring for anxiety and pain have been previously described (Benfield et al., 2001)Scores range between 0 and 100 mm. Lower scores mean less pain.
Semi-structured interview
Time frame: Immediately following immersion
Individual semi-structured interviews will be completed to explore participant's overall perceptions of the immersion intervention and its effect on their general well-being and symptoms. Interviews will be conducted in a conversational tone, using open-ended questions, and active listening techniques. An interview guide consisting of questions related to the intervention and participant cues will direct the conversation The interview will be initiated using a grand tour question, such as "Tell me about your experience while immersed in the water. How did you feel?" then proceed to more directed questions related to specific symptoms related to specific emotional and psychological responses to the intervention (immersion). All interviews will be audio-recorded and transcribed, however, if any participants do not consent to be recorded, the researcher will take notes. Interviews are expected to take approximately 30 - 60 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 20453024Benfield RD, Hortobagyi T, Tanner CJ, Swanson M, Heitkemper MM, Newton ER. The effects of hydrotherapy on anxiety, pain, neuroendocrine responses, and contraction dynamics during labor. Biol Res Nurs. 2010 Jul;12(1):28-36. doi: 10.1177/1099800410361535. Epub 2010 May 7.
- Background: PubMed 7007402Epstein M, Preston S, Weitzman RE. Isoosmotic central blood volume expansion suppresses plasma arginine vasopressin in normal man. J Clin Endocrinol Metab. 1981 Feb;52(2):256-62. doi: 10.1210/jcem-52-2-256.
- Background: PubMed 877449Farhi LE, Linnarsson D. Cardiopulmonary readjustments during graded immersion in water at 35 degrees C. Respir Physiol. 1977 Jun;30(1-2):35-50. doi: 10.1016/0034-5687(77)90020-2.
- Background: PubMed 9679185Hammerum MS, Bie P, Pump B, Johansen LB, Christensen NJ, Norsk P. Vasopressin, angiotensin II and renal responses during water immersion in hydrated humans. J Physiol. 1998 Aug 15;511 ( Pt 1)(Pt 1):323-30. doi: 10.1111/j.1469-7793.1998.323bi.x.
- Background: PubMed 9292451Johansen LB, Jensen TU, Pump B, Norsk P. Contribution of abdomen and legs to central blood volume expansion in humans during immersion. J Appl Physiol (1985). 1997 Sep;83(3):695-9. doi: 10.1152/jappl.1997.83.3.695.
- Background: PubMed 16002223Nater UM, La Marca R, Florin L, Moses A, Langhans W, Koller MM, Ehlert U. Stress-induced changes in human salivary alpha-amylase activity -- associations with adrenergic activity. Psychoneuroendocrinology. 2006 Jan;31(1):49-58. doi: 10.1016/j.psyneuen.2005.05.010. Epub 2005 Jul 5.
- Background: PubMed 17418498Nater UM, Rohleder N, Schlotz W, Ehlert U, Kirschbaum C. Determinants of the diurnal course of salivary alpha-amylase. Psychoneuroendocrinology. 2007 May;32(4):392-401. doi: 10.1016/j.psyneuen.2007.02.007. Epub 2007 Apr 5.
- Background: PubMed 26247781Petrakova L, Doering BK, Vits S, Engler H, Rief W, Schedlowski M, Grigoleit JS. Psychosocial Stress Increases Salivary Alpha-Amylase Activity Independently from Plasma Noradrenaline Levels. PLoS One. 2015 Aug 6;10(8):e0134561. doi: 10.1371/journal.pone.0134561. eCollection 2015.
- Background: PubMed 17222428de Kloet CS, Vermetten E, Geuze E, Wiegant VM, Westenberg HG. Elevated plasma arginine vasopressin levels in veterans with posttraumatic stress disorder. J Psychiatr Res. 2008 Feb;42(3):192-8. doi: 10.1016/j.jpsychires.2006.11.009. Epub 2007 Jan 11.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-Traumatic
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.
Rebecca Benfield, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Immersion in people with Stress Disorders, Post-Traumatic, run by University of Nevada, Las Vegas 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 May 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary Alpha-Amylase change is being assessed (time frame: Pre Immersion Baseline (dry) Immersion at 15 minutes (wet) and 45 minutes (wet)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309031, which also lists 9 linked publications.
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 13 May 2024.