An Immersion Intervention for Symptoms of PTSD in Student Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Multidimensional Mood State Questionnaire (MDMQ) Change is being assessed
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Multidimensional Mood State Questionnaire (MDMQ) Change is being assessed
时间窗: 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 Pain Change is being assessed
时间窗: 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.
Visual Analogue Scale (VAS) for Anxiety Change is being assessed
时间窗: 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.
Salivary Alpha-Amylase change is being assessed
时间窗: 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.
Semi-structured interview
时间窗: 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.
次要结局
未报告次要终点
研究者
Rebecca Benfield
Principal Investigator
University of Nevada, Las Vegas