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Minimal Contact Control for Post-Traumatic Stress Disorder (STRONG STAR Trial)

N/A
Waitlist Available
Led By Edna B. Foa, Ph.D.
Research Sponsored by University of Pennsylvania
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 baseline to 6-month follow-up (approximately 34 weeks for spaced pe and pct, 26 weeks for massed pe
Awards & highlights

STRONG STAR Trial Summary

The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).

Eligible Conditions
  • Post-Traumatic Stress Disorder

STRONG STAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6-month follow-up (approximately 34 weeks for spaced pe and pct, 26 weeks for massed pe
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-month follow-up (approximately 34 weeks for spaced pe and pct, 26 weeks for massed pe for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Secondary outcome measures
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment
PTSD Checklist-Stressor-specific version (PCL-S)

STRONG STAR Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: PE-MassedExperimental Treatment1 Intervention
Group II: Minimal Contact ControlExperimental Treatment1 Intervention
Group III: PE-SpacedActive Control1 Intervention
Group IV: Present-Centered Therapy (PCT)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure Therapy - Massed
2010
N/A
~370
Minimal Contact Control
2010
N/A
~370

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioOTHER
454 Previous Clinical Trials
90,410 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
286 Previous Clinical Trials
245,393 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,012 Previous Clinical Trials
42,896,843 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~25 spots leftby May 2025