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Behavioral Intervention
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
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
No Placebo-Only Group
Summary
This trial tests a sound-based treatment called SSP to help people with Autism or trauma manage stress and emotions better. It involves listening to special sounds that train the nervous system. The study will observe the effects of SSP on participants.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety
Post Traumatic Stress Disorder Symptoms
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2014
Completed Phase 3
~3440
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,838 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