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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
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 weeks
Treatment ~ Varies
Follow Up ~2--4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2--4 months for reporting.

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
1,039 Previous Clinical Trials
1,219,012 Total Patients Enrolled
Spencer PsychologyUNKNOWN
Jacek Kolacz, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Psychotherapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04999852 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Psychotherapy (treatment as usual), Psychotherapy + SSP
Post-Traumatic Stress Disorder Clinical Trial 2023: Psychotherapy Highlights & Side Effects. Trial Name: NCT04999852 — N/A
Psychotherapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999852 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04999852 — N/A
~11 spots leftby Nov 2025
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