Clinical trial NCT01542372: Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
Official title: Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD
Cognitive behavioral therapy (CBT)
Medication augmentation
Treatment-resistant PTSD
Cambodian refugees
Culturally sensitive treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 114
Sex: ALL
Minimum age (years): 43
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* PTSD;
* PCL great or equal to 44;
* Survivor of the Cambodian genocide;
* At least 7 years old at the time of the Cambodian genocide

Exclusion Criteria:

* Pregnant;
* Active suicidality;
* Mental retardation;
* Organic mental disorder;
* Bipolar disorder;
* Alcohol dependence;
* Marijuana dependence;
* Unable to give conformed consent

Primary outcomes:
measure: Change in the PTSD Checklist (PCL) at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in the HSCL Anxiety Scale at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
measure: Change in the HSCL Depression Scale at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
measure: Change in the SCL Anger Severity at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
measure: Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
measure: Change in the SF-12 at 12 Weeks in Step II
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Devon E. Hinton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: