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NCT01492348 · ClinicalTrials.gov registry record · NA
Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- NA
- Development phase
- 666
- Enrollment target
NCT01492348: Completed NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT01492348 is a NA study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 666 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01492348, a NA study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 666 participants
- Enrollment target
Study Summary
The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More specifically, the investigators will test the effectiveness of a telephone care management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC). Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and depression symptom severity compared to participants assigned to OUC over 12-months of follow-up. Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater improvements in somatic symptom severity, alcohol use, mental health functioning, and work functioning compared to participants assigned to OUC over 12-months of follow-up. Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in terms of dollars per quality adjusted life years saved. Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians, care managers, and family members will report that STEPS UP is acceptable, effective, satisfying, and appropriate PTSD and depression care.
Primary Outcome
The PDS (Foa, 1996) is a 49-item self-report measure that assesses both severity of PTSD symptoms related to a single identified traumatic event and probable diagnosis of PTSD.
Interventions
- BEHAVIORAL STEPS UP
- BEHAVIORAL OUC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01492348 record still lists
NCT01492348 is an interventional study that assigns participants to a tested intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which STEPS UP is the first listed.
NCT01492348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01492348 about?
NCT01492348 is a clinical study titled "Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial". The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More specifically, the investigators will test the effectiveness of a telephone care management with preferenc...
What is the current status of trial NCT01492348?
This trial is currently completed. It is a NA study. The enrollment target is 666 participants. The study started on 2012-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01492348?
The interventions under investigation include: STEPS UP (BEHAVIORAL), OUC (BEHAVIORAL).
Who is sponsoring clinical trial NCT01492348?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01492348's enrollment target sits among peer trials
666 155th of 2000 higher than 1,846 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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