Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01542372 · ClinicalTrials.gov registry record · Phase 4
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
NCT01542372: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01542372 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 114 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542372, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
Study Summary
This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those patients who still have PTSD, the second step is either another medication or a culturally sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients will improve in both models, but more so in the the CBT model.
Primary Outcome
A measure of PTSD severity, which is the PTSD Checklist. Total score range is 17 to 85, with a higher score indicating greater psychopathology. Change scores were calculated.
Interventions
- BEHAVIORAL CBT
- DRUG Medication augmentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
Why NCT01542372 stopped before completion
NCT01542372 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which CBT is the first listed.
NCT01542372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542372 about?
NCT01542372 is a clinical study titled "Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD". This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SSRN), wit...
What is the current status of trial NCT01542372?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2012-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01542372?
The interventions under investigation include: CBT (BEHAVIORAL), Medication augmentation (DRUG).
Who is sponsoring clinical trial NCT01542372?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01542372's enrollment target sits among peer trials
114 720th of 2000 higher than 1,278 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04522791 · 114 participants · Phase 2
Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
- NCT04875052 · 114 participants · NA
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
- NCT05100342 · 114 participants
Prospective Validation of a Points Score System Predicting 30-day Survival
- NCT05224089 · 114 participants · Phase 4
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia