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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Two Stepped Care Models for PTSD Among Cambodian Refugees With PTSD

Conditions
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Posttraumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Drug: Medication augmentation
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 43 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medication augmentation<br>In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD | Drug: Medication augmentation<br> <br> * Other names: Prazosin is the first choice agent in this Arm;|
| Active Comparator: CBT augmentation<br>In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD. | Behavioral: CBT<br> <br> * Other names: Cognitive-Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the PTSD Checklist (PCL) at 12 Weeks in Step II | 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. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the HSCL Anxiety Scale at 12 Weeks in Step II | A measure of anxiety severity, which is the HSCL Anxiety Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated. | Baseline and 12 weeks | 
| Change in the HSCL Depression Scale at 12 Weeks in Step II | A measure of depression severity, which is the HSCL Depression Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated. | Baseline and 12 weeks | 
| Change in the SCL Anger Severity at 12 Weeks in Step II | A measure of anger severity, which is the SCL Anger Scale. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated. | Baseline and 12 weeks | 
| Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II | A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated. | Baseline and 12 weeks | 
| Change in the SF-12 at 12 Weeks in Step II | A measure of severity of self-perceived functioning. Total score ranges from 0 to 100, with a higher score indicating better self-perceived functioning. Change scores were calculated. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Cognitive behavioral therapy (CBT), Medication augmentation, Treatment-resistant PTSD, Cambodian refugees, Culturally sensitive treatment