The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD
- Conditions
- Post-Traumatic Stress Disorders
- Interventions
- Other: Floatation-based reduced environmental stimulation therapy
- Registration Number
- NCT04368689
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
- 18-60 years of age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Floating Floatation-based reduced environmental stimulation therapy Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.
- Primary Outcome Measures
Name Time Method Change in Positive and Negative Affect 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 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) 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 Baseline, week 2, week 3 Center for Epidemiologic Studies Depression Scale - Revised Diagnostic tool for criteria for a major depressive episode
Change in stress symptom score 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.
Change in Sheehan Disability Scale score 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) 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 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 Baseline, week 2, week 3 Wong-Baker Pain scale Rates current level of pain from 0 to 10.
Change in Visual Analogue Scales score 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 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 Baseline, week 2, week 3 Fordyce Happiness Measure Measures emotional well being by perceived happiness
Change in present moment sleepiness Baseline, week 2, week 3 Karolinska Sleepiness Scale Single item measure of present moment sleepiness
Change in Skin Conductance response post float 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.
Overall Anxiety Severity and Impairment score pre float 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.
Occurrence of adverse events post float 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/MaybeChange in blood pressure post float 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States