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临床试验/NCT04368689
NCT04368689招募中不适用

The Feasibility and Examination of the Effects of Floatation-based Reduced Environmental Stimulation Therapy (REST) on a Community Sample With Posttraumatic Stress Disorder (PTSD)

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Change in stress symptom score

研究概览

简要总结

This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.

详细描述

This pilot study looks to further the current floatation-based REST literature by exploring the therapy's effectiveness within a community-based sample of adults with PTSD. This type of sample allows the study the opportunity to recruit both veteran and civilian subjects, two populations that can suffer from this clinical diagnosis and stand to benefit from this therapy. This study will:

  1. Evaluate the psychological effects of floating for a clinical, community sample with PTSD.
  2. Evaluate the physiological effects of floating for a clinical, community sample with PTSD.
  3. Evaluate the subjective effects of floating for a clinical, community sample with PTSD.

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
  • •18-60 years of age

排除标准

  • •History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
  • •Any skin conditions or open wounds that could cause pain when exposed to saltwater
  • •Has floated previously
  • •Has Schizophrenia spectrum or other psychotic disorders
  • •Refuses to adhere to the Pre-Float Checklist
  • •Non-English speaking
  • •Inability to lay comfortably in a shallow pool of water
  • •Refuses participation in the floatation-REST sessions
  • •Refuses to sign the Float Liability Waiver prior to floating
  • •No Communicable disease (e.g.- HIV, Hepatitis A, B& C, tuberculosis, or measles)
  • •No psychoactive drugs or laxatives within the past week from scheduled float. Psychoactive drugs include, but are not limited to: methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), psilocybin, peyote, phencyclidine, ketamine).No recreational drug use (e.g.tetrahydrocannabinol,abuse of prescription medicine) day before or day of study visit. No antihistamine that causes drowsiness and no alcohol the day of the float sessions.
  • •Lack of control of bodily functions prior to scheduled float
  • •Fresh tattoos that would inhibit ability to float (consult with tattoo artist)
  • •Colored/dyed hair less than one week old from scheduled float
  • •Body tanning/spay/paint less than one week old from scheduled float
  • •Active suicidal ideation

研究组 & 干预措施

Floating

Experimental

Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.

干预措施: Floatation-based reduced environmental stimulation therapy (Other)

结局指标

主要结局

Change in stress symptom score

时间窗: Baseline, week 2, week 3

Perceived Stress Scale The Perceived Stress Scale is a psychological instrument used for measuring an individual's perception of stress.

Overall Anxiety Severity and Impairment score pre float

时间窗: Baseline

Overall Anxiety Severity and Impairment Scale A 5-item questionnaire that can be used across the different anxiety disorders as a continuous measure of anxiety severity and impairment over the past week. Each item is rated on a 5-point scale and the ratings are summed to obtain a total score ranging from 0 to 20.

Change in Positive and Negative Affect

时间窗: Baseline, week 2, week 3

Positive and Negative Affect Schedule - Expanded Form 20-items survey assessing general states of positive and negative affect using on a 5 point scale

Change in Side effect checklist score

时间窗: Baseline, week 2, week 3

Side effect checklist 43-item side effect checklist to assess the safety of Floatation- REST, and potential adverse experiences.

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

时间窗: Baseline, week 2, week 3

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) A clinician-administered structured diagnostic interview that is considered the gold standard for assessing and diagnosing PTSD.

Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised

时间窗: Baseline, week 2, week 3

Center for Epidemiologic Studies Depression Scale - Revised Diagnostic tool for criteria for a major depressive episode

Change in Sheehan Disability Scale score

时间窗: Baseline, week 2, week 3

Sheehan Disability Scale How much mental health issues have affected their daily activities: work/school, social/leisure activities, and family life/home responsibilities. Total disability scores range between 0 to 30, with scores ≥ 5 signifying impairment.

Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9)

时间窗: Baseline, week 2, week 3

Patient Health Questionnaire (PHQ-9) The PHQ-9 is a 9-Item measure for assessing the severity of depressive symptoms over the past 2 weeks. Scores of 1-4 are considered indicative of minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.

Change in anxiety symptom severity score

时间窗: Baseline, week 2, week 3

State-Trait Anxiety Inventory 20-item self-report questionnaire designed to assess an individual's level of anxiety.

Change in pain score

时间窗: Baseline, week 2, week 3

Wong-Baker Pain scale Rates current level of pain from 0 to 10.

Change in Visual Analogue Scales score

时间窗: Baseline, week 2, week 3

Visual Analogue Scales- Relaxation, Muscle tension, Content/Peaceful, Refreshed, Energy \& Overall Well-Being 7 measures rating on a 100-point scale and assessing overall well-being using a bipolar valence scale that goes from "Pretty Bad" to "Pretty Good"

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5

时间窗: Baseline, week 2, week 3

PTSD Checklist for DSM-5 The PCL-5 consists of 20 items and it takes 5 to 10 minutes to administer. Participants are instructed to answer items based on their experience of symptoms since the trauma (hospitalization) or in the last month (1 month). Each item corresponds to a symptom in the DSM-5.

Change in perceived happiness score

时间窗: Baseline, week 2, week 3

Fordyce Happiness Measure Measures emotional well being by perceived happiness

Change in present moment sleepiness

时间窗: Baseline, week 2, week 3

Karolinska Sleepiness Scale Single item measure of present moment sleepiness

Change in Skin Conductance response post float

时间窗: Baseline, Week 2, week 3

Skin Conductance This will be measured using a program called "eSense". eSense (Mindfield Biosystems LLC), an ambulatory system for collecting skin conductance, or sweat gland activity. eSense samples skin conductance at 5 Hz, substantially lower than more traditional (and more expensive) laboratory systems. This will be done during the Trauma Narrative where subjects are asked to describe an event that they consider to be the most traumatic in their life including: who was there, what they were doing, where they were, how things looked, what they heard, etc.

Occurrence of adverse events post float

时间窗: Week 3

Debriefing Interview Occurrence of adverse events and qualitative information about floating. How was your float today? What did you think about while floating? Did anything surprise you? Did you learn anything about yourself? Follow-up Questions At the end of your float, how did you feel about the duration? Wanted to get out before/Perfect amount of time/Wish I could have stayed longer. Other techniques tried to help relax and feel less anxious and stressed? anti-anxiety medication/psychotherapy/massage/exercise/alcohol/breathing techniques/cigarettes/marijuana/progressive muscle relaxation/meditation/yoga/other Experience during and after today's float session compared to the other relaxation techniques tired? More relaxation with others/Equally as good as the others/More relaxation with floating than any others Interested in floating again in the future and thoughts on specialized pools being effective therapy for reducing symptom severity? Yes/No/Maybe

Change in blood pressure post float

时间窗: Baseline, Week 2, week 3

-Blood Pressure This will be measured using a blood pressure cuff. This is performed before and after each float.

Change in number of mental health disorder diagnostic criteria met

时间窗: Baseline, Week 3

-Mini International Neuropsychiatric Interview - Depression (M.I.N.I. 7.0.2) The MINI is a short structured diagnostic interview designed to meet the need for a short but accurate psychiatric interview determining diagnostic criteria for 17 of the most common disorders in mental health. This version is for DSM-5 and ICD-10 diagnoses. The measure's psychometric properties of diagnostic validity and reliability have been determined to be strong

Anxiety sensitivity severity score pre float

时间窗: Baseline

-Anxiety Sensitivity Index (ASI-3) 18-item questionnaire using a 4-point scale and total ASI scores can range from 0 to 72. A meta-analysis \[46\] found that patient groups with anxiety and depression commonly have a total ASI score above 30, and other studies have used a cutoff score ≥ 30 to recruit individuals with very high levels of anxiety sensitivity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Terri deRoon Cassini

Associate Professor

Medical College of Wisconsin

研究点 (1)

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