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Behavioral Intervention
Safe and Sound Protocol for Post-Traumatic Stress Disorder
N/A
Waitlist Available
Led By Jacek Kolacz, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2--4 months
Awards & highlights
Study Summary
This trial aims to study the effects of the SSP on individuals with PTSD.
Eligible Conditions
- Post Traumatic Stress Disorder
- Anxiety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2--4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2--4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Post Traumatic Stress Disorder Symptoms
Secondary outcome measures
Mean heart period during posture shifts [SSP arm only]
Respiratory sinus arrhythmia (RSA) during posture shifts [SSP arm only]
Self-reported disruption of autonomic reactivity
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psychotherapy + SSPExperimental Treatment2 Interventions
All subjects enrolled in this study will receive the SSP intervention
Group II: Psychotherapy (treatment as usual)Active Control1 Intervention
Subjects who are receiving psychotherapy but not the SSP intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Safe and Sound Protocol
2021
N/A
~50
Psychotherapy
2020
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,115 Total Patients Enrolled
Spencer PsychologyUNKNOWN
Jacek Kolacz, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but this is not a screening criterion. It appears to be a statement about a specific client at a psychology clinic.You have already agreed with your therapist to use SSP (Safe and Sound Protocol) as part of your therapy.You have been diagnosed with post-traumatic stress disorder (PTSD) or other unspecified trauma.
Research Study Groups:
This trial has the following groups:- Group 1: Psychotherapy (treatment as usual)
- Group 2: Psychotherapy + SSP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04999852 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacant positions available in this experiment for potential participants?
"According to clinicaltrials.gov, this particular medical study is not currently seeking any new participants. This trial was opened on July 12th 2021 and updated lastly on September 15th 2022; however there are almost 1,000 other studies that are actively recruiting patients at the present time."
Answered by AI
What are the major goals that this clinical experiment is aiming to achieve?
"Over a period of 2-4 months, this research is aiming to evaluate the impact of reducing Anxiety. To support these objectives, secondary metrics such as Mean heart period during posture shifts using Photoplethysmography, Self-reported disruption of autonomic reactivity with Body Perception Questionnaire and Respiratory sinus arrhythmia (RSA) measured through earlobe pulse sensor will be assessed. High values in each metric may lead to greater therapeutic efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Spencer Psychology
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been wanting to enter into a clinical trial to see how it was, but they have many interesting trials that genuinely seem helpful. I have severe PTSD and am open to see what kind of medicine will help me!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How much is the compensation, how long is the trial and what is the process?
PatientReceived 2+ prior treatments
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