NCT01542372

Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD

Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 43 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project aims to investigate the efficacy of two models to treat PTSD for Cambodian refugees in primary care. The first step in both models is giving a medication (an SSRI/SSRN, e.g., paroxetine). For those who still have PTSD, the second step is either adding another medication (e.g., prazosin) or providing culturally sensitive cognitive behavioral therapy (CBT). We hypothesize that patients will improve in both models, but more so in the the CBT model. The primary outcome measure is PTSD severity as assessed by the PTSD Checklist (PCL). Eligibility requirements include having PTSD and having been old enough to remember the Khmer Rouge period.

Conditions

• Posttraumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
DRUG	Medication augmentation
BEHAVIORAL	CBT

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-03-02
• Last updated: 2017-05-17
• Results posted: 2017-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study